NIMH Data Archive - Data

Genomics

Neuroimaging

Phenotype¹

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Clinical Trial

¹ Numbers reported are subjects by age

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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.

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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.

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Treatment of SSRI-Resistant Depression in Adolescents (TORDIA) #2150

General
Experiments (0)
Shared Data
Publications (29)
Associated Studies (2)

Collection Title	Collection Investigators	Collection Description
Collection Title:	Treatment of SSRI-Resistant Depression in Adolescents (TORDIA)
Collection Investigators:	David A. Brent
Collection Description:	In this seven-year, multisite study, we propose to compare four strategies for the treatment of SSRI-resistant adolescent major depressive disorder (MDD) and/or Dysthymic Disorder. Up to four hundred adolescents, aged 12-18, who continue to be depressed despite an adequate trial with any of the commonly used SSRIs for which there is some evidence of efficacy (i.e., citalopram, escitalopram, fluoxetine, fluvoxamine, or sertraline) will be randomly assigned to one of four conditions to be delivered over 12 weeks. Adolescents currently taking paroxetine will not be entered into the protocol. The rate of clinically acceptable response to treatment and direct cost of treatment will be compared across the four cells in a 2 x 2 factorial design:a. Switch within SSRI class (those on fluoxetine switch to citalopram; those on citalopram or escitalopram switch to fluoxetine; those on fluvoxamine or sertraline are randomly assigned to either fluoxetine or citalopram) b. Switch to a different class of agent (venlafaxine) c. Switch within SSRI class plus cognitive behavior therapy (CBT); ord. Switch to a different class of agent (venlafaxine) plus CBT
Data Repository:	NIMH Data Archive
Permission Group:
Collection Creation Date:	03/31/2015
Collection Phase:	Funding Completed
Collection Sub-Phase:	Close Out
Blinded Clinical Trial:	No
Total Funded Amount:	$2,924,178.00
Subjects Shared:	429

{"values":[]}

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Funding Sources:

Funding Source Name	Funding Source URL
NIH - Extramural	None

Supporting Documentation:

File Name	File Type	Description	Audience
AMTF.pdf	Background	Additional Monitoring Tracking Form	Qualified Researchers
COST DATA FORM.csv	Results	COST Data	Qualified Researchers
COST.pdf	Background	COST Data Form	Qualified Researchers
Additional Monitoring and Tracking Form.csv	Results	AMTF Data	Qualified Researchers
2.1 Data Collection Instruments and Tables.PDF	Methods	List of instruments	Qualified Researchers
1.1 Brief overview of the TORDIA trial.pdf	Methods	Trial Overview	Qualified Researchers
1.2 TORDIA protocol.PDF	Methods	Trial Protocol	Qualified Researchers

Grant Information:

Project Number	Project Title	Start Date	End Date	Planned Enrollment	Actual Enrollment	Organization	Funds Obligated
U01MH061835-01	TREATMENT OF SSRI RESISTANT DEPRESSION IN ADOLESCENTS	09/22/2000	08/31/2007	Not Reported	61	UNIVERSITY OF PITTSBURGH AT PITTSBURGH	$2,924,178.00

Clinical Trials:

Brief Summary	Status	Clinical Trial ID	Study ID	Principal Investigator	Start Date	End Date
The purpose of the study is to determine how best to treat adolescents with depression that is "resistant" to the first SSRI antidepressant they have tried. Participants receive one of three other antidepressant medications, either alone or in combination with cognitive behavioral therapy.	Completed	NCT00018902	U01MH061835	David A. Brent, MD	January 2001	March 2007

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
Adverse Events	Clinical Assessments	177
Beck Anxiety Inventory	Clinical Assessments	330
Beck Depression Inventory	Clinical Assessments	334
Beck Hopelessness Scale	Clinical Assessments	334
CBT Expectations	Clinical Assessments	126
Change in Study Status	Clinical Assessments	236
Child Behavior Checklist (CBCL) 6-18	Clinical Assessments	333
Child and Adolescent Services Assessment	Clinical Assessments	315
Childrens Depression Rating Scale Revised	Clinical Assessments	334
Clinical Global Impression (CGI)	Clinical Assessments	334
Clinical Global Impression of Severity	Clinical Assessments	334
Clinical Monitoring Form	Clinical Assessments	151
Clinical Trials: Inclusion/Exclusion Criteria	Clinical Assessments	334
Clinical Trials: Randomization	Clinical Assessments	334
Conflict Behavior - Parent about Teen	Clinical Assessments	330
Conflict Behavior - Teen about Parents	Clinical Assessments	334
Demographics	Clinical Assessments	334
Drug Screen	Clinical Assessments	6
ECG Results	Clinical Assessments	332
Family History	Clinical Assessments	331
Guess of Treatment Condition	Clinical Assessments	291
Kiddie Post Traumatic Stress Scale	Clinical Assessments	334
Kiddie-Sads ADHD Supplement	Clinical Assessments	131
Kiddie-Sads CD CU	Clinical Assessments	85
Kiddie-Sads Depression	Clinical Assessments	334
Kiddie-Sads Mania Rating Scale	Clinical Assessments	334
Kiddie-Sads Manic Hypomania	Clinical Assessments	221
Kiddie-Sads OCD	Clinical Assessments	42
Kiddie-Sads ODD	Clinical Assessments	116
Kiddie-Sads PTSD	Clinical Assessments	334
Kiddie-Sads Summary Diagnoses	Clinical Assessments	334
Kiddie-SadsSubstance Use	Clinical Assessments	334
Medical History	Clinical Assessments	334
Medications	Clinical Assessments	334
Pharmacotherapy Session Checklist	Clinical Assessments	334
Screen for Child Anxiety Related Disorders (SCARED), Parent/Child	Clinical Assessments	334
Serious Adverse Events	Clinical Assessments	52
Side Effects	Clinical Assessments	334
Social Adjustment Scale	Clinical Assessments	334
Suicidal Ideation Questionnaire	Clinical Assessments	334
Suicide Questionnaire	Clinical Assessments	334

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
32579280	Create Study	What next? A Bayesian hierarchical modeling re-examination of treatments for adolescents with selective serotonin reuptake inhibitor-resistant depression.	Depression and anxiety	Suresh, Vikram; Mills, Jeffrey A; Croarkin, Paul E; Strawn, Jeffrey R	September 2020	Not Determined
24290459	Create Study	Protecting adolescents from self-harm: a critical review of intervention studies.	Journal of the American Academy of Child and Adolescent Psychiatry	Brent DA, McMakin DL, Kennard BD, Goldstein TR, Mayes TL, Douaihy AB	December 2013	Not Determined
24024532	Create Study	The bidirectional relationship between body mass index and treatment outcome in adolescents with treatment-resistant depression.	Journal of child and adolescent psychopharmacology	Mansoor, Brandon; Rengasamy, Manivel; Hilton, Robert; Porta, Giovanna; He, Jiayan; Spirito, Anthony; Emslie, Graham J; Mayes, Taryn L; Clarke, Gregory; Wagner, Karen Dineen; Shamseddeen, Wael; Birmaher, Boris; Ryan, Neal; Brent, David	September 2013	Not Determined
23975354	Create Study	Concurrent trajectories of change in adolescent and maternal depressive symptoms in the TORDIA study.	Journal of youth and adolescence	Perloe A, Esposito-Smythers C, Curby TW, Renshaw KD	April 2014	Not Determined
23622849	Create Study	Impact of treatments for depression on comorbid anxiety, attentional, and behavioral symptoms in adolescents with selective serotonin reuptake inhibitor-resistant depression.	Journal of the American Academy of Child and Adolescent Psychiatry	Hilton RC, Rengasamy M, Mansoor B, He J, Mayes T, Emslie GJ, Porta G, Clarke GN, Wagner KD, Birmaher B, Keller MB, Ryan N, Shamseddeen W, Asarnow JR, Brent DA	May 2013	Not Determined
23582868	Create Study	The bi-directional relationship between parent-child conflict and treatment outcome in treatment-resistant adolescent depression.	Journal of the American Academy of Child and Adolescent Psychiatry	Rengasamy M, Mansoor BM, Hilton R, Porta G, He J, Emslie GJ, Mayes T, Clarke GN, Wagner KD, Keller MB, Ryan ND, Birmaher B, Shamseddeen W, Asarnow JR, Brent DA	April 2013	Not Determined
22449646	Create Study	Anhedonia predicts poorer recovery among youth with selective serotonin reuptake inhibitor treatment-resistant depression.	Journal of the American Academy of Child and Adolescent Psychiatry	McMakin DL, Olino TM, Porta G, Dietz LJ, Emslie G, Clarke G, Wagner KD, Asarnow JR, Ryan ND, Birmaher B, Shamseddeen W, Mayes T, Kennard B, Spirito A, Keller M, Lynch FL, Dickerson JF, Brent DA	April 2012	Not Determined
22284022	Create Study	Do sub-syndromal manic symptoms influence outcome in treatment resistant depression in adolescents? A latent class analysis from the TORDIA study.	Journal of affective disorders	Maalouf, Fadi T; Porta, Giovanna; Vitiello, Benedetto; Emslie, Graham; Mayes, Taryn; Clarke, Gregory; Wagner, Karen D; Asarnow, Joan Rosenbaum; Spirito, Anthony; Keller, Martin; Birmaher, Boris; Ryan, Neal; Shamseddeen, Wael; Iyengar, Satish; Brent, David	April 2012	Not Determined
22251024	Create Study	Adjunctive sleep medications and depression outcome in the treatment of serotonin-selective reuptake inhibitor resistant depression in adolescents study.	Journal of child and adolescent psychopharmacology	Shamseddeen W, Clarke G, Keller MB, Wagner KD, Birmaher B, Emslie GJ, Ryan N, Asarnow JR, Porta G, Brent DA	February 2012	Not Determined
22251022	Create Study	Out of the black box: treatment of resistant depression in adolescents and the antidepressant controversy.	Journal of child and adolescent psychopharmacology	Wagner KD, Asarnow JR, Vitiello B, Clarke G, Keller M, Emslie GJ, Ryan N, Porta G, Iyengar S, Ritz L, Zelanzny J, Onorato M, Brent D	February 2012	Not Determined
22024002	Create Study	Treatment-resistant depressed youth show a higher response rate if treatment ends during summer school break.	Journal of the American Academy of Child and Adolescent Psychiatry	Shamseddeen, Wael; Clarke, Gregory; Wagner, Karen Dineen; Ryan, Neal D; Birmaher, Boris; Emslie, Graham; Asarnow, Joan Rosenbaum; Porta, Giovanna; Mayes, Taryn; Keller, Martin B; Brent, David A	November 2011	Not Determined
21784297	Create Study	Suicide attempts and nonsuicidal self-injury in the treatment of resistant depression in adolescents: findings from the TORDIA study.	Journal of the American Academy of Child and Adolescent Psychiatry	Asarnow JR, Porta G, Spirito A, Emslie G, Clarke G, Wagner KD, Vitiello B, Keller M, Birmaher B, McCracken J, Mayes T, Berk M, Brent DA	August 2011	Not Determined
21515198	Create Study	Pharmacokinetically and clinician-determined adherence to an antidepressant regimen and clinical outcome in the TORDIA trial.	Journal of the American Academy of Child and Adolescent Psychiatry	Woldu H, Porta G, Goldstein T, Sakolsky D, Perel J, Emslie G, Mayes T, Clarke G, Ryan ND, Birmaher B, Wagner KD, Asarnow JR, Keller MB, Brent D	May 2011	Not Determined
21383263	Create Study	Incremental cost-effectiveness of combined therapy vs medication only for youth with selective serotonin reuptake inhibitor-resistant depression: treatment of SSRI-resistant depression in adolescents trial findings.	Archives of general psychiatry	Lynch FL, Dickerson JF, Clarke G, Vitiello B, Porta G, Wagner KD, Emslie G, Asarnow JR, Keller MB, Birmaher B, Ryan ND, Kennard B, Mayes T, DeBar L, McCracken JT, Strober M, Suddath RL, Spirito A, Onorato M, Zelazny J, Iyengar S, Brent D	March 2011	Not Determined
21334569	Create Study	Impact of physical and sexual abuse on treatment response in the Treatment of Resistant Depression in Adolescent Study (TORDIA).	Journal of the American Academy of Child and Adolescent Psychiatry	Shamseddeen, Wael; Asarnow, Joan Rosenbaum; Clarke, Gregory; Vitiello, Benedetto; Wagner, Karen Dineen; Birmaher, Boris; Keller, Martin B; Emslie, Graham; Iyengar, Satish; Ryan, Neal D; McCracken, James T; Porta, Giovanna; Mayes, Taryn; Brent, David A	March 2011	Not Determined
21208583	Create Study	Long-term outcome of adolescent depression initially resistant to selective serotonin reuptake inhibitor treatment: a follow-up study of the TORDIA sample.	The Journal of clinical psychiatry	Vitiello B, Emslie G, Clarke G, Wagner KD, Asarnow JR, Keller MB, Birmaher B, Ryan ND, Kennard B, Mayes TL, DeBar L, Lynch F, Dickerson J, Strober M, Suddath R, McCracken JT, Spirito A, Onorato M, Zelazny J, Porta G, Iyengar S, Brent DA	March 2011	Not Determined
21192150	Create Study	Antidepressant exposure as a predictor of clinical outcomes in the Treatment of Resistant Depression in Adolescents (TORDIA) study.	Journal of clinical psychopharmacology	Sakolsky DJ, Perel JM, Emslie GJ, Clarke GN, Wagner KD, Vitiello B, Keller MB, Birmaher B, Asarnow JR, Ryan ND, McCracken JT, Strober MJ, Iyengar S, Porta G, Brent DA	February 2011	Not Determined
20504254	Create Study	Pharmacogenomics of suicidal events.	Pharmacogenomics	Brent D, Melhem N, Turecki G	June 2010	Not Determined
20478877	Create Study	Treatment of Resistant Depression in Adolescents (TORDIA): week 24 outcomes.	The American journal of psychiatry	Emslie GJ, Mayes T, Porta G, Vitiello B, Clarke G, Wagner KD, Asarnow JR, Spirito A, Birmaher B, Ryan N, Kennard B, DeBar L, McCracken J, Strober M, Onorato M, Zelazny J, Keller M, Iyengar S, Brent D	July 2010	Not Determined
20008943	Create Study	Association of FKBP5 polymorphisms with suicidal events in the Treatment of Resistant Depression in Adolescents (TORDIA) study.	The American journal of psychiatry	Brent, David; Melhem, Nadine; Ferrell, Robert; Emslie, Graham; Wagner, Karen Dineen; Ryan, Neal; Vitiello, Benedetto; Birmaher, Boris; Mayes, Taryn; Zelazny, Jamie; Onorato, Matthew; Devlin, Bernie; Clarke, Greg; DeBar, Lynn; Keller, Marty	February 2010	Not Determined
19858762	Create Study	Substance use and the treatment of resistant depression in adolescents.	Journal of the American Academy of Child and Adolescent Psychiatry	Goldstein, Benjamin I; Shamseddeen, Wael; Spirito, Anthony; Emslie, Graham; Clarke, Greg; Wagner, Karen Dineen; Asarnow, Joan Rosenbaum; Vitiello, Benedetto; Ryan, Neal; Birmaher, Boris; Mayes, Taryn; Onorato, Matthew; Zelazny, Jamie; Brent, David A	December 2009	Not Determined
19798756	Create Study	The treatment of SSRI-resistant depression in adolescents (TORDIA): in search of the best next step.	Depression and anxiety	Brent DA	2009	Not Determined
19485586	Create Study	Sources of site differences in the efficacy of a multisite clinical trial: the Treatment of SSRI-Resistant Depression in Adolescents.	Journal of consulting and clinical psychology	Spirito A, Abebe KZ, Iyengar S, Brent D, Vitiello B, Clarke G, Wagner KD, Asarnow J, Emslie G, Keller M	June 2009	Not Determined
19223438	Create Study	Predictors of spontaneous and systematically assessed suicidal adverse events in the treatment of SSRI-resistant depression in adolescents (TORDIA) study.	The American journal of psychiatry	Brent DA, Emslie GJ, Clarke GN, Asarnow J, Spirito A, Ritz L, Vitiello B, Iyengar S, Birmaher B, Ryan ND, Zelazny J, Onorato M, Kennard B, Mayes TL, Debar LL, McCracken JT, Strober M, Suddath R, Leonard H, Porta G, Keller MB	April 2009	Not Determined
19220597	Create Study	Pediatric depression: is there evidence to improve evidence-based treatments?	Journal of child psychology and psychiatry, and allied disciplines	Brent DA, Maalouf FT	January 2009	Not Determined
19182688	Create Study	Treatment of selective serotonin reuptake inhibitor-resistant depression in adolescents: predictors and moderators of treatment response.	Journal of the American Academy of Child and Adolescent Psychiatry	Asarnow, Joan Rosenbaum; Emslie, Graham; Clarke, Greg; Wagner, Karen Dineen; Spirito, Anthony; Vitiello, Benedetto; Iyengar, Satish; Shamseddeen, Wael; Ritz, Louise; Birmaher, Boris; Ryan, Neal; Kennard, Betsy; Mayes, Taryn; DeBar, Lynn; McCracken, James; Strober, Michael; Suddath, Robert; Leonard, Henrietta; Porta, Giovanna; Keller, Martin; Brent, David	March 2009	Not Determined
18314433	Create Study	Switching to another SSRI or to venlafaxine with or without cognitive behavioral therapy for adolescents with SSRI-resistant depression: the TORDIA randomized controlled trial.	JAMA	Brent, David; Emslie, Graham; Clarke, Greg; Wagner, Karen Dineen; Asarnow, Joan Rosenbaum; Keller, Marty; Vitiello, Benedetto; Ritz, Louise; Iyengar, Satish; Abebe, Kaleab; Birmaher, Boris; Ryan, Neal; Kennard, Betsy; Hughes, Carroll; DeBar, Lynn; McCracken, James; Strober, Michael; Suddath, Robert; Spirito, Anthony; Leonard, Henrietta; Melhem, Nadine; Porta, Giovanna; Onorato, Matthew; Zelazny, Jamie	February 27, 2008	Not Determined
16952773	Create Study	Treatment-resistant depression in adolescents: recognition and management.	Child and adolescent psychiatric clinics of North America	Brent DA, Birmaher B	October 2006	Not Determined
16952763	Create Study	Depressive disorders in childhood and adolescence: an overview: epidemiology, clinical manifestation and risk factors.	Child and adolescent psychiatric clinics of North America	Zalsman G, Brent DA, Weersing VR	October 2006	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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Collection Owners and those with Collection Administrator permission, may edit a collection. The following is currently available for Edit on this page:

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.	429/1356	Secondary Analysis	Shared
What next? A Bayesian Hierarchical Modeling Re-Examination of Treatments for Adolescents with Selective Serotonin Reuptake Inhibitor-Resistant Depression	Background: Psychiatrists frequently struggle with how to sequence treatment for depressed adolescents who do not respond to an adequate trial of a selective serotonin reuptake inhibitor (SSRI). This study leveraged recent statistical and computational advances to create Bayesian Hierarchal Models (BHMs) of response in the Treatment of SSRI-resistant Depression (TORDIA) study to inform treatment planning. Methods: BHMs of individual treatment trajectories were developed and estimated using Hamiltonian Monte Carlo No U-Turn Sampling. From the Monte Carlo pseudorandom sample, 95% credible intervals, means, posterior tail probabilities, etc. were determined. Then, for random effects models, posterior tail probabilities were used to create Bayesian two-tailed p-values to evaluate the null hypotheses: no difference in efficacy between SSRIs and venlafaxine. The robustness of the results was examined using fixed effects models of treatment comparisons. Results: In patients not receiving cognitive behavioral therapy (CBT) (n=168), SSRIs produced greater and faster improvement in depressive symptoms compared to venlafaxine (p=0.015). No differences in response or trajectory of response for symptoms of anxiety were detected between SSRIs and venlafaxine (p=0.168). For patients receiving CBT (n=162), SSRIs and venlafaxine produced similar improvements in symptoms of anxiety and depression. Conclusions: Findings from this novel computational approach suggest that a second trial of an SSRI is warranted for depressed adolescents who fail to respond to initial SSRI treatment.	429/429	Secondary Analysis	Shared

* Data not on individual level

helpcenter.collection.associated-studies-tab

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.

Frequently Asked Questions

How do I associate a study to my collection?

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

Glossary

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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