NIMH Data Archive - Data

Genomics

Neuroimaging

Phenotype¹

New Trial
Clinical Trial

¹ Numbers reported are subjects by age

New Project
Grant/Project Number

Format should be in the following format: Activity Code, Institute Abbreviation, and Serial Number. Grant Type, Support Year, and Suffix should be excluded. For example, grant 1R01MH123456-01A1 should be entered R01MH123456

Collection - Use Existing Experiment

To associate an experiment to the current collection, just select an axperiment from the table below then click the associate experiment button to persist your changes (saving the collection is not required). Note that once an experiment has been associated to two or more collections, the experiment will not longer be editable.

The table search feature is case insensitive and targets the experiment id, experiment name and experiment type columns. The experiment id is searched only when the search term entered is a number, and filtered using a startsWith comparison. When the search term is not numeric the experiment name is used to filter the results.

Select	Experiment Id	Experiment Name	Experiment Type	Created On

24	HI-NGS_R1	Omics	02/16/2011
475	MB1-10 (CHOP)	Omics	06/07/2016
490	Illumina Infinium PsychArray BeadChip Assay	Omics	07/07/2016
501	PharmacoBOLD Resting State	fMRI	07/27/2016
506	PVPREF	Omics	08/05/2016
509	ABC-CT Resting v2	EEG	08/18/2016
13	Comparison of FI expression in Autistic and Neurotypical Homo Sapiens	Omics	12/28/2010
18	AGRE/Broad Affymetrix 5.0 Genotype Experiment	Omics	01/06/2011
22	Stitching PCR Sequencing	Omics	02/14/2011
26	ASD_Methylation	Omics	03/01/2011
29	Microarray family 03 (father, mother, sibling)	Omics	03/24/2011
37	Standard paired-end sequencing of BCRs	Omics	04/19/2011
38	Illumina Mate-Pair BCR sequencing	Omics	04/19/2011
39	Custom Jumping Libraries	Omics	04/19/2011
40	Custom CapBP	Omics	04/19/2011
41	Immunofluorescence	Omics	05/11/2011
43	Autism brain sample genotyping, Illumina	Omics	05/16/2011
47	ARRA Autism Sequencing Collaboration at Baylor. SOLiD 4 System	Omics	08/01/2011
53	AGRE Omni1-quad	Omics	10/11/2011
59	AGP genotyping	Omics	04/03/2012
60	Ultradeep 454 sequencing of synaptic genes from postmortem cerebella of individuals with ASD and neurotypical controls	Omics	06/23/2012
63	Microemulsion PCR and Targeted Resequencing for Variant Detection in ASD	Omics	07/20/2012
76	Whole Genome Sequencing in Autism Families	Omics	01/03/2013
519	Resting	fMRI	11/08/2016
90	Genotyped IAN Samples	Omics	07/09/2013
91	NJLAGS Axiom Genotyping Array	Omics	07/16/2013
93	AGP genotyping (CNV)	Omics	09/06/2013
106	Longitudinal Sleep Study. H20 200. Channel set 2	EEG	11/07/2013
107	Longitudinal Sleep Study. H20 200. Channel set 3	EEG	11/07/2013
108	Longitudinal Sleep Study. AURA 200	EEG	11/07/2013
105	Longitudinal Sleep Study. H20 200. Channel set 1	EEG	11/07/2013
109	Longitudinal Sleep Study. AURA 400	EEG	11/07/2013
116	Gene Expression Analysis WG-6	Omics	01/07/2014
131	Jeste Lab UCLA ACEii: Charlie Brown and Sesame Street - Project 1	Eye Tracking	02/27/2014
132	Jeste Lab UCLA ACEii: Animacy - Project 1	Eye Tracking	02/27/2014
133	Jeste Lab UCLA ACEii: Mom Stranger - Project 2	Eye Tracking	02/27/2014
134	Jeste Lab UCLA ACEii: Face Emotion - Project 3	Eye Tracking	02/27/2014
145	AGRE/FMR1_Illumina.JHU	Omics	04/14/2014
146	AGRE/MECP2_Sanger.JHU	Omics	04/14/2014
147	AGRE/MECP2_Junior.JHU	Omics	04/14/2014
151	Candidate Gene Identification in familial Autism	Omics	06/09/2014
152	NJLAGS Whole Genome Sequencing	Omics	07/01/2014
154	Math Autism Study - Vinod Menon	fMRI	07/15/2014
155	Resting	fMRI	07/25/2014
156	Speech	fMRI	07/25/2014
159	Emotion	fMRI	07/25/2014
160	syllable contrast	EEG	07/29/2014
167	School-age naturalistic stimuli	Eye Tracking	09/19/2014
44	AGRE/Broad Affymetrix 5.0 Genotype Experiment	Omics	06/27/2011
45	Exome Sequencing of 20 Sporadic Cases of Autism Spectrum Disorder	Omics	07/15/2011

Collection - Add Experiment

Add Supporting Documentation

Funding Source:
URL:

To add an existing Data Structure, enter its title in the search bar. If you need to request changes, select the indicator "No, it requires changes to meet research needs" after selecting the Structure, and upload the file with the request changes specific to the selected Data Structure. Your file should follow the Request Changes Procedure. If the Data Structure does not exist, select "Request New Data Structure" and upload the appropriate zip file.

Use/Modify Existing Data Structure

Request New Data Structure

Targeted Enrollment:

Initial Submission Date:

Initial Share Date:

Data Structure Search:

Data Structures:

Submit

Request Submission Exemption

Not Eligible

The Data Expected list for this Collection shows some raw data as missing. Contact the NDA Help Desk with any questions.

Please confirm that you will not be enrolling any more subjects and that all raw data has been collected and submitted.

Collection Updated

Your Collection is now in Data Analysis phase and exempt from biannual submissions. Analyzed data is still expected prior to publication or no later than the project end date.

[CMS] Error

[CMS]

Unable to change collection phase where targeted enrollment is less than 90%

You have requested to move the sharing dates for the following assessments:

Data Expected Item	Original Sharing Date	New Sharing Date

Please provide a reason for this change, which will be sent to the Program Officers listed within this collection:

Explanation must be between 20 and 200 characters in length.

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Treatment for Adolescents with Depression Study (TADS)/Substance Use and Other Outcomes Following Treatment for Adolescent Depression (SOFTAD ) #2145

General
Experiments (0)
Shared Data
Publications (5)
Associated Studies (4)

Collection Title	Collection Investigators	Collection Description
Collection Title:	Treatment for Adolescents with Depression Study (TADS)/Substance Use and Other Outcomes Following Treatment for Adolescent Depression (SOFTAD )
Collection Investigators:	John F. Curry and John March
Collection Description:	TADS is designed to compare the effectiveness of established treatments for teenagers suffering from major depressive disorder (MDD). The treatments are: psychotherapy ("talking therapy"); medication; and the combination of psychotherapy and medication. Altogether, 432 teenagers (both males and females) ages 12 to 17, will take part in this study at 12 sites in the United States.The TADS design will provide answers to the following questions: What is the long-term effectiveness of medication treatment of teenagers who have major depression? What is the long-term effectiveness of a specific psychotherapy (talking therapy) in the treatment of teenagers who have major depression? How does medication treatment compare with psychotherapy in terms of effectiveness, tolerability and teenager and family acceptance? And, What is the cost-effectiveness of medication, psychotherapy and combined treatments? The medication being used in this study is called fluoxetine. Fluoxetine is also known as Prozac. Research has shown that medications like Prozac help depression in young persons. Fluoxetine has been approved by the FDA for use in the treatment of child and adolescent (ages 7 to 17 years) depression.The psychotherapy or "talking therapy" being used in this study is called Cognitive Behavioral Therapy (CBT). CBT is a talking therapy that will teach both the teenager and his or her family member (e.g., parent) new skills to cope better with depression. Specific topics include education about depression and the causes of depression, setting goals, monitoring mood, increasing pleasant activities, social problem-solving, correcting negative thinking, negotiation, compromise and assertiveness. CBT sessions may also help with resolving disagreements as they affect families. SOFTAD is a 3.5 year follow-up to the treatment study entitled Treatment for Adolescents with Depression Study (TADS). TADS was a multi-center, randomized clinical trial designed to evaluate the short and long-term effectiveness of four treatments for 439 adolescents with major depressive disorder (MDD): fluoxetine (FLX, n=109), MDD-specific cognitive-behavior therapy (CBT, n=111); their combination (COMB, n=107); and, acutely, pill placebo (PBO, n=112). Both illicit drug use and SUDs are associated with leading causes of death in adolescents: homicide, suicide and motor vehicle accidents. Not surprisingly, adolescent psychopathology is a risk factor for SUDs. Additionally, comorbid MDD and SUDs are common and are associated with more severe SUDs and with higher risk for suicide. In adolescent clinical samples, MDD often precedes SUDs. Therefore, effective treatment of MDD may lower the risk for development of subsequent SUDs. The SOFTAD recruited 196 of 439 adolescents enrolled and randomized to treatment in TADS. In SOFTAD, the TADS participants were followed for an additional 3.5 years to assess whether successful treatment of MDD reduces risk of subsequent Substance Use Disorders (SUDs) and other outcomes.
Data Repository:	NIMH Data Archive
Permission Group:
Collection Creation Date:	09/27/2015
NIH Research Initiative:	NIMH Repository & Genomics Resource (NRGR)
Collection Phase:	Funding Completed
Collection Sub-Phase:	Close Out
Blinded Clinical Trial:	No
Total Funded Amount:	$2,764,421.00
Subjects Shared:	439

{"values":[]}

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Funding Sources:

Funding Source Name	Funding Source URL
NIH - Extramural	None
NIH - Contract	None

Supporting Documentation:

File Name	File Type	Description	Audience
SOFTAD Protocol.pdf	Analysis Protocol	SOFTAD Protocol	Qualified Researchers
SOFTAD Published Reports.pdf	Analysis Protocol	SOFTAD Published Reports	Qualified Researchers
TADS_Overview.pdf	Objectives	TADS Overview	Qualified Researchers
TADS_Protocol_2000_Jan_04.pdf	Analysis Protocol	TADS Protocol	Qualified Researchers
TADS_Protocol_Revisions_2001_JAN_03.pdf	Analysis Protocol	TADS Protocol Revisions	Qualified Researchers
TADS_Publications_2008_Oct.pdf	Publication	TADS Publications	Qualified Researchers
TADS_Methods_JAACAP_2003_MAY.pdf	Methods	TADS Methods	Qualified Researchers
TADS_Assessment_Tables.pdf	Methods	TADS Assessment Tables	Qualified Researchers
TADS_Baseline_JAACAP_2005_JAN.pdf	Methods	TADS Baseline	Qualified Researchers
SOFTAD_site.xlsx	Other	Coded Site Number	Qualified Researchers
TADS_hwk.xlsx	Other	CBT Homework Completion Form	Qualified Researchers
TADS_icd10.xlsx	Other	ICD-10 Coding of Baseline Depression	Qualified Researchers
TADS_ieb.xlsx	Other	Independent Evaluator Blindness	Qualified Researchers
TADS_site.xlsx	Other	Coded Site Number	Qualified Researchers
NDA Dictionary to TADS_SOFTADS Instruments.pdf	Methods	NDCT Dictionary to TADS/SOFTADS Instrument	Qualified Researchers

Grant Information:

Project Number	Project Title	Start Date	End Date	Planned Enrollment	Actual Enrollment	Organization	Funds Obligated
R01MH070494-01	SOFTAD Substance Use Outcomes Following TAD	09/01/2003	11/30/2010	300	196	DUKE UNIVERSITY	$2,764,421.00

Clinical Trials:

Brief Summary	Status	Clinical Trial ID	Study ID	Principal Investigator	Start Date	End Date
TADS is designed to compare the effectiveness of established treatments for teenagers suffering from major depressive disorder (MDD). The treatments are: psychotherapy ("talking therapy"); medication; and the combination of psychotherapy and medication. Altogether, 432 teenagers (both males and females) ages 12 to 17, will take part in this study at 12 sites in the United States. The TADS design will provide answers to the following questions: What is the long-term effectiveness of medication treatment of teenagers who have major depression? What is the long-term effectiveness of a specific psychotherapy ("talking therapy) in the treatment of teenagers who have major depression? How does medication treatment compare with psychotherapy in terms of effectiveness, tolerability and teenager and family acceptance? And, What is the cost-effectiveness of medication, psychotherapy and combined treatments? The medication being used in this study is called fluoxetine. Fluoxetine is also known as Prozac. Research has shown that medications like Prozac help depression in young persons. Fluoxetine has been approved by the FDA for use in the treatment of child and adolescent (ages 7 to 17 years) depression. The psychotherapy or "talking therapy" being used in this study is called Cognitive Behavioral Therapy (CBT). CBT is a talking therapy that will teach both the teenager and his or her family member (e.g., parent) new skills to cope better with depression. Specific topics include education about depression and the causes of depression, setting goals, monitoring mood, increasing pleasant activities, social problem-solving, correcting negative thinking, negotiation, compromise and assertiveness. CBT sessions may also help with resolving disagreements as they affect families.	Completed	NCT00006286	N01 MH80008	Anne Marie Albano	September 1998	March 2004

helpcenter.collection.general-tab

Collection - General Tab

Fields available for edit on the top portion of the page include:

Collection Title
Investigators
Collection Description
Collection Phase
Funding Source
Clinical Trials

Collection Phase: The current status of a research project submitting data to an NDA Collection, based on the timing of the award and/or the data that have been submitted.

Pre-Enrollment: The default entry made when the NDA Collection is created.
Enrolling: Data have been submitted to the NDA Collection or the NDA Data Expected initial submission date has been reached for at least one data structure category in the NDA Collection.
Data Analysis: Subject level data collection for the research project is completed and has been submitted to the NDA Collection. The NDA Collection owner or the NDA Help Desk may set this phase when they’ve confirmed data submission is complete and submitted subject counts match at least 90% of the target enrollment numbers in the NDA Data Expected. Data submission reminders will be turned off for the NDA Collection.
Funding Completed: The NIH grant award (or awards) associated with the NDA Collection has reached its end date. NDA Collections in Funding Completed phase are assigned a subphase to indicate the status of data submission.
- The Data Expected Subphase indicates that NDA expects more data will be submitted
- The Closeout Subphase indicates the data submission is complete.
- The Sharing Not Met Subphase indicates that data submission was not completed as expected.

Blinded Clinical Trial Status:

This status is set by a Collection Owner and indicates the research project is a double blinded clinical trial. When selected, the public view of Data Expected will show the Data Expected items and the Submission Dates, but the targeted enrollment and subjects submitted counts will not be displayed.
Targeted enrollment and subjects submitted counts are visible only to NDA Administrators and to the NDA Collection or as the NDA Collection Owner.
When an NDA Collection that is flagged Blinded Clinical Trial reaches the maximum data sharing date for that Data Repository (see https://nda.nih.gov/nda/sharing-regimen.html), the embargo on Data Expected information is released.

Funding Source

The organization(s) responsible for providing the funding is listed here.

Supporting Documentation

Users with Submission privileges, as well as Collection Owners, Program Officers, and those with Administrator privileges, may upload and attach supporting documentation. By default, supporting documentation is shared to the general public, however, the option is also available to limit this information to qualified researchers only.

Grant Information

Identifiable details are displayed about the Project of which the Collection was derived from. You may click in the Project Number to view a full report of the Project captured by the NIH.

Clinical Trials

Any data that is collected to support or further the research of clinical studies will be available here. Collection Owners and those with Administrator privileges may add new clinical trials.

Frequently Asked Questions

How does the NIMH Data Archive (NDA) determine which Permission Group data are submitted into?

During Collection creation, NDA staff determine the appropriate Permission Group based on the type of data to be submitted, the type of access that will be available to data access users, and the information provided by the Program Officer during grant award.
How do I know when a NDA Collection has been created?

When a Collection is created by NDA staff, an email notification will automatically be sent to the PI(s) of the grant(s) associated with the Collection to notify them.
Is a single grant number ever associated with more than one Collection?

The NDA system does not allow for a single grant to be associated with more than one Collection; therefore, a single grant will not be listed in the Grant Information section of a Collection for more than one Collection.
Why is there sometimes more than one grant included in a Collection?

In general, each Collection is associated with only one grant; however, multiple grants may be associated if the grant has multiple competing segments for the same grant number or if multiple different grants are all working on the same project and it makes sense to hold the data in one Collection (e.g., Cooperative Agreements).

Glossary

Administrator Privilege

A privilege provided to a user associated with an NDA Collection or NDA Study whereby that user can perform a full range of actions including providing privileges to other users.
Collection Owner

Generally, the Collection Owner is the contact PI listed on a grant. Only one NDA user is listed as the Collection owner. Most automated emails are primarily sent to the Collection Owner.
Collection Phase
The Collection Phase provides information on data submission as opposed to grant/project completion so while the Collection phase and grant/project phase may be closely related they are often different. Collection users with Administrative Privileges are encouraged to edit the Collection Phase. The Program Officer as listed in eRA (for NIH funded grants) may also edit this field. Changes must be saved by clicking the Save button at the bottom of the page. This field is sortable alphabetically in ascending or descending order. Collection Phase options include:
- Pre-Enrollment: A grant/project has started, but has not yet enrolled subjects.
- Enrolling: A grant/project has begun enrolling subjects. Data submission is likely ongoing at this point.
- Data Analysis: A grant/project has completed enrolling subjects and has completed all data submissions.
- Funding Completed: A grant/project has reached the project end date.
Collection Title

An editable field with the title of the Collection, which is often the title of the grant associated with the Collection.
Grant

Provides the grant number(s) for the grant(s) associated with the Collection. The field is a hyperlink so clicking on the Grant number will direct the user to the grant information in the NIH Research Portfolio Online Reporting Tools (RePORT) page.
Supporting Documentation

Various documents and materials to enable efficient use of the data by investigators unfamiliar with the project and may include the research protocol, questionnaires, and study manuals.
NIH Research Initiative

NDA Collections may be organized by scientific similarity into NIH Research Initiatives, to facilitate query tool user experience. NIH Research Initiatives map to one or multiple Funding Opportunity Announcements.
Permission Group

Access to shared record-level data in NDA is provisioned at the level of a Permission Group. NDA Permission Groups consist of one or multiple NDA Collections that contain data with the same subject consents.
Planned Enrollment

Number of human subject participants to be enrolled in an NIH-funded clinical research study. The data is provided in competing applications and annual progress reports.
Actual Enrollment

Number of human subjects enrolled in an NIH-funded clinical research study. The data is provided in annual progress reports.
NDA Collection

A virtual container and organization structure for data and associated documentation from one grant or one large project/consortium. It contains tools for tracking data submission and allows investigators to define a wide array of other elements that provide context for the data, including all general information regarding the data and source project, experimental parameters used to collect any event-based data contained in the Collection, methods, and other supporting documentation. They also allow investigators to link underlying data to an NDA Study, defining populations and subpopulations specific to research aims.
Data Use Limitations

Data Use Limitations (DULs) describe the appropriate secondary use of a dataset and are based on the original informed consent of a research participant. NDA only accepts consent-based data use limitations defined by the NIH Office of Science Policy.
Total Subjects Shared

The total number of unique subjects for whom data have been shared and are available for users with permission to access data.

Contact NDA Help Desk

ID	Name	Created Date	Status	Type
No records found.

helpcenter.collection.experiments-tab

Collection - Experiments

The number of Experiments included is displayed in parentheses next to the tab name. You may download all experiments associated with the Collection via the Download button. You may view individual experiments by clicking the Experiment Name and add them to the Filter Cart via the Add to Cart button.

Collection Owners, Program Officers, and users with Submission or Administrative Privileges for the Collection may create or edit an Experiment.

Please note: The creation of an NDA Experiment does not necessarily mean that data collected, according to the defined Experiment, has been submitted or shared.

Frequently Asked Questions

Can an Experiment be associated with more than one Collection?
Yes -see the “Copy” button in the bottom left when viewing an experiment. There are two actions that can be performed via this button:
1. Copy the experiment with intent for modifications.
2. Associate the experiment to the collection. No modifications can be made to the experiment.

Glossary

Experiment Status

An Experiment must be Approved before data using the associated Experiment_ID may be uploaded.
Experiment ID

The ID number automatically generated by NDA which must be included in the appropriate file when uploading data to link the Experiment Definition to the subject record.

Contact NDA Help Desk

Shared Data:

Title	Type	Number of Subjects
Across-Trial Core Variables	Clinical Assessments	439
Adjunct Services Attrition Prevention	Clinical Assessments	180
Adverse Events	Clinical Assessments	192
Affective Disorders Screen	Clinical Assessments	434
Beck Depression Inventory	Clinical Assessments	439
Beck Hopelessness Scale	Clinical Assessments	437
Brief Symptom Inventory	Clinical Assessments	438
CBT Expectations	Clinical Assessments	211
CBT Treatment Session Checklist	Clinical Assessments	271
Child and Adolescent Impact Assessment	Clinical Assessments	436
Child and Adolescent Services Assessment	Clinical Assessments	439
Children's Attributional Style Questionnaire	Clinical Assessments	433
Childrens Depression Rating Scale Revised	Clinical Assessments	439
Childrens Negative Cognitive Error Questionnaire	Clinical Assessments	434
Clinical Global Impression (CGI)	Clinical Assessments	439
Clinical Trials. Demographics	Clinical Assessments	196
Cognitive Triad Inventory for Children	Clinical Assessments	431
Concomitant Treatment	Clinical Assessments	439
Conflict Behavior - Parent about Teen	Clinical Assessments	438
Conflict Behavior - Teen about Parents	Clinical Assessments	434
Conners Adult ADHD Rating Scales	Clinical Assessments	434
Conners Parent Rating Scales Revised (CPRS) 2002	Clinical Assessments	437
Conners-Wells Self-Report Scale	Clinical Assessments	436
Consent Form Questionnaire	Clinical Assessments	326
Consumer Satisfaction Survey	Clinical Assessments	389
Demographic Questionnaire	Clinical Assessments	439
Dyadic Adjustment Scale	Clinical Assessments	314
Dysfunctional Attitudes Scale	Clinical Assessments	436
Family Assessment Measure	Clinical Assessments	439
Family History Form	Clinical Assessments	196
Health of Nation Outcomes Scales	Clinical Assessments	439
Issues Checklist	Clinical Assessments	438
Kiddie-Sads Summary Diagnoses	Clinical Assessments	439
Major Depressive Episodes Log	Clinical Assessments	196
Medication Count Log Summary and Medication Compliance	Clinical Assessments	328
Menstrual History	Clinical Assessments	239
Multidimensional Anxiety Scale for Children Parent and Self	Clinical Assessments	438
Pediatric Life Events Screen	Clinical Assessments	428
Pediatric Quality of Life Scale	Clinical Assessments	428
Peer Substance Use	Clinical Assessments	194
Peer Tolerance of Substance Use	Clinical Assessments	194
Perceived Criticism Questionnaire	Clinical Assessments	196
Personal Experience Screening Form	Clinical Assessments	436
Pharmacotherapy Session Checklist	Clinical Assessments	326
Physical Examination	Clinical Assessments	435
Physical Symptom Checklist	Clinical Assessments	433
Psychiatric Treatment Log	Clinical Assessments	196
Research Subject	Clinical Assessments	171
Reynolds Adolescent Depression Scale	Clinical Assessments	439
Smoking History Questionnaire	Clinical Assessments	194
Social Problem-Solving Inventory	Clinical Assessments	434
Stages of Change	Clinical Assessments	418
Study Screening Log	Clinical Assessments	439
Substance Abuse Disorders Log	Clinical Assessments	196
Suicidal Ideation Questionnaire	Clinical Assessments	437
Tanner Sexual Maturity Scale	Clinical Assessments	428
Teen Trauma History	Clinical Assessments	439
Treatment Assignment Reaction	Clinical Assessments	438
Treatment Blindness	Clinical Assessments	245
Treatment Expectancy: Parent and Adolescent	Clinical Assessments	432
Wechsler Individual Achievement Test Third Edition. Part II	Clinical Assessments	429
Wechsler Intelligence Scale for Children III	Clinical Assessments	429

helpcenter.collection.shared-data-tab

Collection - Shared Data

This tab provides a quick overview of the Data Structure title, Data Type, and Number of Subjects that are currently Shared for the Collection. The information presented in this tab is automatically generated by NDA and cannot be edited. If no information is visible on this tab, this would indicate the Collection does not have shared data or the data is private.

The shared data is available to other researchers who have permission to access data in the Collection's designated Permission Group(s). Use the Download button to get all shared data from the Collection to the Filter Cart.

Frequently Asked Questions

How will I know if another researcher uses data that I shared through the NIMH Data Archive (NDA)?

To see what data your project have submitted are being used by a study, simply go the Associated Studies tab of your collection. Alternatively, you may review an NDA Study Attribution Report available on the General tab.
Can I get a supplement to share data from a completed research project?

Often it becomes more difficult to organize and format data electronically after the project has been completed and the information needed to create a GUID may not be available; however, you may still contact a program staff member at the appropriate funding institution for more information.
Can I get a supplement to share data from a research project that is still ongoing?

Unlike completed projects where researchers may not have the information needed to create a GUID and/or where the effort needed to organize and format data becomes prohibitive, ongoing projects have more of an opportunity to overcome these challenges. Please contact a program staff member at the appropriate funding institution for more information.

Glossary

Data Structure

A defined organization and group of Data Elements to represent an electronic definition of a measure, assessment, questionnaire, or collection of data points. Data structures that have been defined in the NDA Data Dictionary are available at https://nda.nih.gov/general-query.html?q=query=data-structure
Data Type

A grouping of data by similar characteristics such as Clinical Assessments, Omics, or Neurosignal data.
Shared

The term 'Shared' generally means available to others; however, there are some slightly different meanings based on what is Shared. A Shared NDA Study is viewable and searchable publicly regardless of the user's role or whether the user has an NDA account. A Shared NDA Study does not necessarily mean that data used in the NDA Study have been shared as this is independently determined. Data are shared according the schedule defined in a Collection's Data Expected Tab and/or in accordance with data sharing expectations in the NDA Data Sharing Terms and Conditions. Additionally, Supporting Documentation uploaded to a Collection may be shared independent of whether data are shared.

Contact NDA Help Desk

Collection Owners and those with Collection Administrator permission, may edit a collection. The following is currently available for Edit on this page:

Publications

Publications relevant to NDA data are listed below. Most displayed publications have been associated with the grant within Pubmed. Use the "+ New Publication" button to add new publications. Publications relevant/not relevant to data expected are categorized. Relevant publications are then linked to the underlying data by selecting the Create Study link. Study provides the ability to define cohorts, assign subjects, define outcome measures and lists the study type, data analysis and results. Analyzed data and results are expected in this way.

PubMed ID	Study	Title	Journal	Authors	Date	Status
26576820	Create Study	Trajectories of Functioning Into Emerging Adulthood Following Treatment for Adolescent Depression.	The Journal of adolescent health : official publication of the Society for Adolescent Medicine	Peters, Amy T; Jacobs, Rachel H; Feldhaus, Claudia; Henry, David B; Albano, Anne Marie; Langenecker, Scott A; Reinecke, Mark A; Silva, Susan G; Curry, John F	March 2016	Not Determined
24661263	Create Study	Mental health service use among adolescents following participation in a randomized clinical trial for depression.	Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53	Brenner, Sharon L; Burns, Barbara J; Curry, John F; Silva, Susan G; Kratochvil, Christopher J; Domino, Marisa Elena	2015	Not Determined
22250853	Create Study	Onset of alcohol or substance use disorders following treatment for adolescent depression.	Journal of consulting and clinical psychology	Curry J, Silva S, Rohde P, Ginsburg G, Kennard B, Kratochvil C, Simons A, Kirchner J, May D, Mayes T, Feeny N, Albano AM, Lavanier S, Reinecke M, Jacobs R, Becker-Weidman E, Weller E, Emslie G, Walkup J, Kastelic E, Burns B, Wells K, March J	April 2012	Not Determined
21041606	Create Study	Recovery and recurrence following treatment for adolescent major depression.	Archives of general psychiatry	Curry J, Silva S, Rohde P, Ginsburg G, Kratochvil C, Simons A, Kirchner J, May D, Kennard B, Mayes T, Feeny N, Albano AM, Lavanier S, Reinecke M, Jacobs R, Becker-Weidman E, Weller E, Emslie G, Walkup J, Kastelic E, Burns B, Wells K, March J	March 2011	Not Determined
20438153	Create Study	Ethnic differences among adolescents beginning treatment for depression.	Cultural diversity & ethnic minority psychology	Stein GL, Curry JF, Hersh J, Breland-Noble A, March J, Silva SG, Reinecke MA, Jacobs R	April 2010	Not Determined

helpcenter.collection.publications-tab

Collection - Publications

The number of Publications is displayed in parentheses next to the tab name. Clicking on any of the Publication Titles will open the Publication in a new internet browsing tab.

Collection Owners, Program Officers, and users with Submission or Administrative Privileges for the Collection may mark a publication as either Relevant or Not Relevant in the Status column.

Frequently Asked Questions

How can I determine if a publication is relevant?

Publications are considered relevant to a collection when the data shared is directly related to the project or collection.
Where does the NDA get the publications?

PubMed, an online library containing journals, articles, and medical research. Sponsored by NiH and National Library of Medicine (NLM).

Glossary

Create Study

A link to the Create an NDA Study page that can be clicked to start creating an NDA Study with information such as the title, journal and authors automatically populated.
Not Determined Publication

Indicates that the publication has not yet been reviewed and/or marked as Relevant or Not Relevant so it has not been determined whether an NDA Study is expected.
Not Relevant Publication

A publication that is not based on data related to the aims of the grant/project associated with the Collection or not based on any data such as a review article and, therefore, an NDA Study is not expected to be created.
PubMed

PubMed provides citation information for biomedical and life sciences publications and is managed by the U.S. National Institutes of Health's National Library of Medicine.
PubMed ID

The PUBMed ID is the unique ID number for the publication as recorded in the PubMed database.
Relevant Publication

A publication that is based on data related to the aims of the grant/project associated with the Collection and, therefore, an NDA Study is expected to be created.

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Associated Studies

Studies that have been defined using data from a Collection are important criteria to determine the value of data shared. The number of subjects column displays the counts from this Collection that are included in a Study, out of the total number of subjects in that study. The Data Use column represents whether or not the study is a primary analysis of the data or a secondary analysis. State indicates whether the study is private or shared with the research community.

Study NameFilter by Study Name	AbstractFilter by Abstract	Collection/Study SubjectsFilter by Collection/Study Subjects	Data UsageFilter by Data Usage	StateFilter by State
Combining selective serotonin reuptake inhibitors and cognitive behavioral therapy in youth with depression and anxiety	Background Treatment studies of children and adolescents with internalizing disorders suggest that the combination of a selective serotonin reuptake inhibitor (SSRI) and cognitive behavioral therapy (CBT) consistently produces greater improvement than either treatment alone. We sought to determine how response to combined treatment varies across disorders (anxiety versus depression), and by specific patient characteristics. Methods Three large National Institutes of Health-funded trials of children and adolescents with major depression (n = 2) and anxiety disorders (n = 1) were evaluated, each comparing CBT + SSRI to SSRI only, Bayesian Hierarchical Models (BHMs) were used, for endpoint response, time course of response and predictors of response in participants who received SSRI or SSRI+CBT. Results SSRI+CBT significantly decreased symptoms by week 4 (p<0.001) across disorders. This improvement continued at week 8 and 12 (p<0.001); however, the additive benefit of CBT over SSRI monotherapy was not statistically significant until week 12 (p<0.001). The fastest response to SSRI+CBT was for patients who were younger, with milder baseline anxiety/depression symptoms and depressive disorders. The slowest response for SSRI+CBT was for boys, adolescents, minoritized children, those with severe symptoms and externalizing disorders. Limitations Limitations included inconsistent moderators, variation in the number of observations over time and a lack of genetic or pharmacokinetic variables related to SSRI exposure across studies. Conclusions The superiority of SSRI+CBT for youth with depression and anxiety is further supported. For purposes of rapid and greater relief, combination treatment is the superior approach across anxiety and depression and is robust to a range of participant characteristics. However, the added value of CBT (with an SSRI) occurs late in treatment. These findings represent a step towards understanding heterogeneity of treatment response and raise the possibility that interventions could be better tailored or adapted based on patient characteristics.	439/1356	Secondary Analysis	Shared
A Restoring Invisible and Abandoned Trials (RIAT) Reanalysis of the Treatment for Adolescents with Depression Study (TADS): Barriers to access to clinical trial data	Increasing numbers of children and adolescents are being prescribed antidepressants, despite uncertainty about the benefits and harms. Most antidepressants remain contraindicated for use in juveniles, because they significantly increase the risk of self-harm and suicidal behaviour. Despite this, dispensing rates have increased in many countries, with trends led largely by guidelines from the United States that have asserted the safety and effectiveness of fluoxetine for adolescents. Funded by the US National Institutes of Health (NIH), the Treatment for Adolescents with Depression Study (TADS) was an influential trial of fluoxetine and Cognitive Behavioural Therapy (CBT), with over 48 publications and 1000 citations. Its methodology and reporting have been strongly criticized. We will reanalyze the original TADS dataset, to assess the validity of its published reports and to investigate unreported findings. The Restoring Invisible and Abandoned Trials (RIAT) initiative provides an important mechanism for increasing accountability in clinical trials. RIAT’s systematic methodology aims to address selective and misleading outcome reporting in clinical trials through rigorous reanalysis of trial data. We will reanalyze the TADS dataset, reporting on key effectiveness and safety outcomes as specified by the original protocol, alongside additional safety outcomes. The TADS study recruited 12-17 year old adolescents with a primary diagnosis of major depressive disorder (MDD) and randomized them to fluoxetine, CBT, combined fluoxetine and CBT, or placebo-based intervention. The TADS team reported that fluoxetine was effective and safe for use in adolescents and that participants who received combined therapy demonstrated the best outcomes. The present paper describes our unsuccessful efforts to obtain more detailed SAE data from TADS' data custodians, highlighting several problematic blocks to comprehensive safety reporting.	439/439	Secondary Analysis	Shared
Treating a broader range of depressed adolescents with combined therapy	Background: Traditional statistical analyses of clinical trials encompass the central tendency of outcomes and, hence, are restricted to a treatment's average effectiveness. Our aim was to get a more complete picture of the effectiveness of standard treatment options for adolescent depression, by analyzing treatment effects across low, middle, and high levels of response. Methods: Secondary data analysis was performed of the Treatment for Adolescents with Depression Study (TADS, ClinicalTrials.gov, NCT00006286), a randomized controlled trial comparing fluoxetine (FLX), cognitive-behavioral therapy (CBT), and their combination (COMB) against placebo treating adolescents with major depression (n=439). The proportional change from baseline to week 12 in the Children's Depression Rating Scale-Revised was used as an index of response. Response levels were analyzed via quantile regression models, thereby estimating treatment effects across the entire response level distribution, adjusted for baseline depression, study site, and patients’ treatment expectancies. Results: Whereas CBT was no more effective than placebo across response levels, COMB was more effective than FLX in that its quantile treatment effects were both larger in magnitude and spread out across a broader range of response levels, including the low end of the response level distribution. Cohen's d of the difference was 1.39 (95% confidence interval 1.33-1.45). Limitations: Ad-hoc analysis using data from a trial that was not originally designed to accommodate such analysis. Conclusion: The combination of cognitive-behavioral therapy and fluoxetine was more effective than either treatment used alone, not just in average effectiveness, but in the breadth of patients in whom it was effective.	439/439	Secondary Analysis	Shared
Estimating patient-specific treatment advantages in the ‘Treatment for Adolescents with Depression Study’	The ‘Treatment for Adolescents with Depression Study’ (TADS, ClinicalTrials.gov, identifier: NCT00006286) was a cornerstone, randomized controlled trial evaluating the effectiveness of standard treatment options for major depression in adolescents. Whereas previous TADS analyses examined primarily effect modifications of treatment-placebo differences by various patient characteristics, less is known about the modification of inter-treatment differences, and hence, patient characteristics that might guide treatment selection. We sought to fill this gap by estimating patient-specific inter-treatment differences as a function of patients’ baseline characteristics. We did so by applying the ‘model-based random forest’, a recently-introduced machine learning-based method for evaluating effect heterogeneity that allows for the estimation of patient-specific treatment effects as a function of arbitrary baseline characteristics. Treatment conditions were cognitive-behavioural therapy (CBT) alone, fluoxetine (FLX) alone, and the combination of CBT and fluoxetine (COMB). All inter-treatment differences (CBT vs. FLX; CBT vs. COMB; FLX vs. COMB) were evaluated across 23 potential effect modifiers extracted from previous studies. Overall, FLX was superior to CBT, while COMB was superior to both CBT and FLX. Evidence for effect heterogeneity was found for the CBT-FLX difference and the FLX-COMB difference, but not for the CBT-COMB difference. Baseline depression severity modified the CBT-FLX difference; whereas baseline depression severity, patients’ treatment expectations, and childhood trauma modified the FLX-COMB difference. All modifications were quantitative rather than qualitative, however, meaning that the differences varied only in magnitude, but not direction. These findings imply that combining CBT with fluoxetine may be superior to either therapy used alone across a broad range of patients.	327/327	Secondary Analysis	Shared

* Data not on individual level

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Collection - Associated Studies

Clicking on the Study Title will open the study details in a new internet browser tab. The Abstract is available for viewing, providing the background explanation of the study, as provided by the Collection Owner.

Primary v. Secondary Analysis: The Data Usage column will have one of these two choices. An associated study that is listed as being used for Primary Analysis indicates at least some and potentially all of the data used was originally collected by the creator of the NDA Study. Secondary Analysis indicates the Study owner was not involved in the collection of data, and may be used as supporting data.

Private v. Shared State: Studies that remain private indicate the associated study is only available to users who are able to access the collection. A shared study is accessible to the general public.

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Studies are associated to the Collection automatically when the data is defined in the Study.

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Associated Studies Tab

A tab in a Collection that lists the NDA Studies that have been created using data from that Collection including both Primary and Secondary Analysis NDA Studies.

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