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NDAR provides a single access to de-identified autism research data. For permission to download data, you will need an NDAR account with approved access to NDAR or a connected repository (AGRE, IAN, or the ATP). For NDAR access, you need to be a research investigator sponsored by an NIH recognized institution with federal wide assurance. See Request Access for more information.

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The filters you have selected from various query interfaces will be stored here, in the 'Filter Cart'. The database will be queried using filters added to your 'Filter Cart', when multiple filters are defined, each will be executed using 'AND' logic, so with each filter that is applied the result set gets smaller.

From the 'Filter Cart' you can inspect each of the filters that have been defined, and you also have the option to remove filters. The 'Filter Cart' itself will display the number of filters applied along with the number of subjects that are identified by the combination of those filters. For example a GUID filter with two subjects, followed by a GUID filter for just one of those subjects would return only data for the subject that is in both GUID filters.

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1 Numbers reported are subjects by age
New Trial
New Project

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

Please select an experiment type below

New Documentation

Please enter the name of the data structure to search or if your definition does not exist, please upload that definition so that it can be appropriately defined for submission. Multiple data structures may be associated with a single Data Expected entry. Please add only one data structure per assessment.

Please provide a reason for the requested submission exemption and the
time-frame during which the exemption will be active.
Shared

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

General

Title, investigators, and Collection Description may be edited along with the Collection Phase. For Collection Phase, the options Pre-enrollment, Enrollment, and Completed can be chosen allowing the Collection Owner to indicate the stage of data collection.

Funding Source

The ability to associate the funding source for the project is provided. For NIH funded grants, linkage to Project Reporter information (e.g. R01MH123456) is supported. Projects funded by others, including the URL of the project, are listed. Non NIH funded projects will become available here to link that data with the appropriate funding agency.

Supporting Documentation

Any documents related to the project may be uploaded clarifying the data or acquisition methods used may be uploaded and made available here. The default is to share these documents to the general public. An option to share only to qualified Researchers is also an option.

Clinical Trials

For clinical trials, the option to link to the clinical trial in clinicaltrials.gov is optionally provided.

Collection Summary Collection Charts
Collection Title Collection Investigators Collection Description
Targeting GABA-A for the Treatment of Social Disability in Young Adults with Autism Spectrum Disorders: A Phase II Proof of Mechanism Trial
James T. McCracken 
Autism Spectrum Disorders (ASD) (DSM-V, APA 2013) include the Pervasive Developmental Disorders (PDDs) previously referred to as Autistic Disorder, Asperger's disorder and PDD-Not Otherwise Specified (NOS). ASD are chronic neurodevelopmental disorders of early childhood onset that are associated with substantial disability, sharing core delays in the development of social communication and interaction skills, and impairing restricted, repetitive behaviors. These disorders occur in all racial, ethnic, and social groups. Recently, there has been an increase in the number of children diagnosed with ASD and seeking services, likely due to broadened case definition and awareness (Fombonne et al., 2006; Schechter & Grether, 2008). The wider spectrum of ASD is estimated to have a prevalence of 1 per 88 children (Autism and Developmental Disorders Monitoring Network, 2012). For individuals with ASD and their families, the impact of these disorders may be considerable and enduring, indeed, the cost of the disability associated with PDD is estimated at 30 billion dollars annually in the U.S. alone. Parent surveys indicate that the use of psychotropic medications has increased by 50% over the past decade, with the majority of individuals with ASD reported taking at least one psychotropic in surveys (Aman et al., 2003; Oswald & Sonenklar, 2007; Esbensen et al, 2010). While use of psychotropics for managing comorbid behavioral problems have some empirical support (McCracken et al, 2002; King and Bostic, 2006; Scahill, 2008; Doyle and McDougle, 2012), there is no identified compound which directly addresses the core domains of ASD, forming a major unmet need for ASD therapeutics. Fortunately, due to advances in the understanding of the biology of ASD, a number of biological targets have been identified which could represent opportunities to intervene to ameliorate core pathophysiology which underpins the disorder. The proposed protocol aims to evaluate one compound, AZD7325, for its suitability for larger-scale testing, by examining its target engagement, safety and tolerability, and preliminary efficacy indices.
NDAR, Clinical Trials
Closed
Shared
$0.00
110
0
0

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NIH - Contract None

Final Data Drug Blood.xlsx Results Drug Blood Results Qualified Researchers
Treatment Group Assignment.docx Background Description of Treatment Group Assignments Qualified Researchers


This study is a NIMH-funded multi-site clinical trial that includes UCLA as the coordinating site, with Emory University and Seattle Children's Hospital, as other recruiting sites, and the Nathan Kline Institute as the Data Management Center. The purpose of the study is to examine the effects of an investigational drug, AZD7325, as a potential treatment for high-functioning adults 18 -35 years old with Autism Spectrum Disorders (ASD). The primary study measures are effects on brain waves as measured by non-invasive brain wave recordings (electroencephalograms or EEGs), assessments of side effects, and measures of attention and learning. The study drug, AZD7325, is manufactured by Astra Zeneca, and was initially tested as a medication for anxiety disorders in over 488 subjects, but was not pursued for marketing due to too few benefits for anxiety. AZD7325 was found to have a very good safety profile and was tolerated by the majority of subjects. AZD7325 has some similar actions to currently marketed anxiety drugs in the benzodiazepine class, but lacks the sedative and negative effects on attention of the benzodiazepines. The study drug is designed to target the GABA neurotransmitter system which is believed to be abnormal in this population. There are 2 study phases. Phase 1 includes the recruitment of 24 healthy volunteers without mental disorder (6 per site) in order to establish normal EEG reference ranges. Controls will only be seen for one study visit which includes a clinical evaluation, physical exam, routine blood tests, and an EEG. Once control recruitment is complete, Phase 2 will begin. Phase 2 involves the recruitment of 40 adults (10 per site) 18 - 35 years old with a diagnosis of ASD, normal intelligence, and specific EEG patterns compared to control values. Screening for eligibility will be performed in one visit, which includes a clinical evaluation, tests of learning and intelligence, blood and urine tests, and an EEG. Those subjects who are found to be eligible will be enrolled in a 6-week medication study. Subjects with ASD who are enrolled will be randomly assigned to receive the study drug AZD7325 or placebo in matching capsules. Subjects will be seen weekly by study physicians and clincians for the 7 study visits, including 3 additional EEG recordings, and then for a final follow-up visit (9 total visits including screening lasting up to 11 weeks to complete). Study physicians can adjust the dose of study medication to reduce any side effects. Completed NCT01966679 HHS-NIH-DA-12-241 James McCracken, MD October 2013 July 2015

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

Experiments

To create a new Omics, eye tracking, fMRI, or EEG experiment, press the "+ New Experiment" button. Once an experiment is created, then raw files for these types of experiments should be provided, associating the experiment – through Experiment_ID – with the metadata defined in the experiments interface.

IDNameCreated DateStatusType
391Faces/ANT tasks10/28/2015ApprovedEEG

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

Shared Data

Data structures with the number of subjects submitted and shared are provided.

Aberrant Behavior Checklist (ABC) - Community Clinical Assessments 43
Adverse Events Clinical Assessments 37
Analyzed EED Data Form Part 2 Imaging 46
Analyzed EEG Data Form Imaging 46
Anxiety Depression and Mood Scale Clinical Assessments 92
Autism Diagnostic Observation Schedule, 2nd Edition (ADOS-2) - Module 4 Clinical Assessments 44
Biospecimen Shipping Form Clinical Assessments 62
Clinical Global Impression (CGI) Clinical Assessments 97
Clinical Lab Tests Clinical Assessments 96
Clinical Trials: Inclusion/Exclusion Criteria Clinical Assessments 97
Clinical Trials: Randomization Clinical Assessments 44
Columbia Suicide Severity Rating Scale Clinical Assessments 44
Concomitant Medications Clinical Assessments 54
Demographics Data Clinical Assessments 97
ECG Results Clinical Assessments 44
EEG Form Imaging 94
EEG Subject Files Imaging 97
End of Study Form Clinical Assessments 44
Medical History Clinical Assessments 97
Medications Dispensing Form Clinical Assessments 44
Mini International Neuropsychiatric Interview. Part I Clinical Assessments 52
Physical Examination Clinical Assessments 97
Physician Withdrawal Checklist Clinical Assessments 43
Psychiatric History Clinical Assessments 97
Reading the Mind in the Eyes Task (RMET) Clinical Assessments 96
Research Subject Clinical Assessments 97
SRS-2. Adult, Preschool and School Age Clinical Assessments 50
Side Effects Clinical Assessments 95
Social Communication Interaction Test Clinical Assessments 44
Vineland-II - Survey Form (2005) Clinical Assessments 41
Vital Signs Clinical Assessments 95
Wechsler Abbreviated Scale of Intelligence (WASI) Clinical Assessments 96

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 NDAR 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 IDStudyTitleJournalAuthorsDateStatus
No records found.

This tab provides a general status on the data expected to be shared. There are two types of data expected.

  1. By Relevant publications — Those publications that reported for the collection's grant and have a status of "relevant" for sharing are listed first. The grantee is expected to share the data specific to those publications using the NDA Study feature. If a publication is erroneously marked relevant, the PI should simply change the status. When sharing a study, only the outcome measures for the subjects/time-points are shared. Other data that have not met the share date, defined below, will remain embargoed. To initiate study creation, simply login, mark your publication as relevant and click on the link listed to begin.

  2. By Data Structure — The number of subjects expected, received and shared is provided. Investigators are expected to update the data that they are collecting, the initial submission date and initial share dates. The NIMH Data Archive shares data when those dates are met.

  3. Submission Exemption — Those with Administrative or Submission Access to the Collection may request an exemption for submission for a defined period by stating the reason and timeframe. Note that the program officer on the grant may review this request.


Relevant Publications
PubMed IDStudyTitleJournalAuthorsDate
No records found.

For those with privileges to edit the collection, it is possible to upload your data definitions using this interface. NDA support staff will then follow up with a harmonized data definition for you to use in providing additional data.

Data Expected
Data ExpectedTargeted EnrollmentInitial SubmissionSubjects SharedStatus
Research Subject and Pedigree info iconApproved
Analyzed EEG info iconApproved
Medications Dispensing Form info iconApproved
Mini-International Neuropsychiatric Interview (MINI) info iconApproved
ABC Community info iconApproved
Clinical Lab Tests info iconApproved
Columbia Suicide Severity Rating Scale info iconApproved
ECG info iconApproved
Medical History info iconApproved
ADOS info iconApproved
Clinical Global Impression (CGI) info iconApproved
Reading the Mind in the Eyes info iconApproved
Social Responsiveness Scale (SRS) info iconApproved
Social Communication Interaction Test (SCIT) info iconApproved
Adverse Event (AE) and Serious Adverse Event (SAE) info iconApproved
EEG info iconApproved
Vineland (Parent and Caregiver) info iconApproved
Side Effects info iconApproved
Clinical Trials: Inclusion/Exclusion Criteria info iconApproved
Vital Signs Assessment info iconApproved
Biospecimen Shipping Form info iconApproved
Wechsler Abbreviated Scale of Intelligence (WASI) info iconApproved
Demographics info iconApproved
End of Study Form info iconApproved
Concomitant Medication info iconApproved
Physical Exam info iconApproved
Medical History info iconApproved
Anxiety Depression and Mood Scale info iconApproved
Physician Withdrawal Checklist info iconApproved
Clinical Trials: Randomization info iconApproved
Structure not yet defined

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.