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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

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.
SelectExperiment IdExperiment NameExperiment Type
Created On
24HI-NGS_R1Omics02/16/2011
475MB1-10 (CHOP)Omics06/07/2016
490Illumina Infinium PsychArray BeadChip AssayOmics07/07/2016
501PharmacoBOLD Resting StatefMRI07/27/2016
506PVPREFOmics08/05/2016
509ABC-CT Resting v2EEG08/18/2016
13Comparison of FI expression in Autistic and Neurotypical Homo SapiensOmics12/28/2010
18AGRE/Broad Affymetrix 5.0 Genotype ExperimentOmics01/06/2011
22Stitching PCR SequencingOmics02/14/2011
26ASD_MethylationOmics03/01/2011
29Microarray family 03 (father, mother, sibling)Omics03/24/2011
37Standard paired-end sequencing of BCRsOmics04/19/2011
38Illumina Mate-Pair BCR sequencingOmics04/19/2011
39Custom Jumping LibrariesOmics04/19/2011
40Custom CapBPOmics04/19/2011
41ImmunofluorescenceOmics05/11/2011
43Autism brain sample genotyping, IlluminaOmics05/16/2011
47ARRA Autism Sequencing Collaboration at Baylor. SOLiD 4 SystemOmics08/01/2011
53AGRE Omni1-quadOmics10/11/2011
59AGP genotypingOmics04/03/2012
60Ultradeep 454 sequencing of synaptic genes from postmortem cerebella of individuals with ASD and neurotypical controlsOmics06/23/2012
63Microemulsion PCR and Targeted Resequencing for Variant Detection in ASDOmics07/20/2012
76Whole Genome Sequencing in Autism FamiliesOmics01/03/2013
519RestingfMRI11/08/2016
90Genotyped IAN SamplesOmics07/09/2013
91NJLAGS Axiom Genotyping ArrayOmics07/16/2013
93AGP genotyping (CNV)Omics09/06/2013
106Longitudinal Sleep Study. H20 200. Channel set 2EEG11/07/2013
107Longitudinal Sleep Study. H20 200. Channel set 3EEG11/07/2013
108Longitudinal Sleep Study. AURA 200EEG11/07/2013
105Longitudinal Sleep Study. H20 200. Channel set 1EEG11/07/2013
109Longitudinal Sleep Study. AURA 400EEG11/07/2013
116Gene Expression Analysis WG-6Omics01/07/2014
131Jeste Lab UCLA ACEii: Charlie Brown and Sesame Street - Project 1Eye Tracking02/27/2014
132Jeste Lab UCLA ACEii: Animacy - Project 1Eye Tracking02/27/2014
133Jeste Lab UCLA ACEii: Mom Stranger - Project 2Eye Tracking02/27/2014
134Jeste Lab UCLA ACEii: Face Emotion - Project 3Eye Tracking02/27/2014
145AGRE/FMR1_Illumina.JHUOmics04/14/2014
146AGRE/MECP2_Sanger.JHUOmics04/14/2014
147AGRE/MECP2_Junior.JHUOmics04/14/2014
151Candidate Gene Identification in familial AutismOmics06/09/2014
152NJLAGS Whole Genome SequencingOmics07/01/2014
154Math Autism Study - Vinod MenonfMRI07/15/2014
155RestingfMRI07/25/2014
156SpeechfMRI07/25/2014
159EmotionfMRI07/25/2014
160syllable contrastEEG07/29/2014
167School-age naturalistic stimuliEye Tracking09/19/2014
44AGRE/Broad Affymetrix 5.0 Genotype ExperimentOmics06/27/2011
45Exome Sequencing of 20 Sporadic Cases of Autism Spectrum DisorderOmics07/15/2011
Collection - Add Experiment
Add Supporting Documentation
Select File

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

[CMS]

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

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You have requested to move the sharing dates for the following assessments:
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Collection Summary Collection Charts
Collection Title Collection Investigators Collection Description
Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD)
Gary Sachs and Michael Thase 
STEP-BD is the largest, federally funded treatment study ever conducted for bipolar disorder (1). It was a long-term outpatient study that enrolled a total of 4,360 participants (1). STEP-BD aimed to find out which treatments, or combinations of treatments, are most effective for treating episodes of depression and mania and for preventing recurrent episodes in people with bipolar disorder. STEP-BD is different from typical clinical trials that test one potential new treatment; it was a broad research program that included several different studies, each aimed at a different aspect of treatment for the illness.
NIMH Data Archive
09/27/2015
NIMH Repository & Genomics Resource (NRGR)
Funding Completed
Close Out
No
4,551
Loading Chart...
NIH - Contract None

LtdSiteStatusSOP.7.16.041.pdf Software SCP Manual of Study Operations Qualified Researchers
Documentation Summary STEP-BD OM3.pdf Methods OM3 Qualified Researchers
Randomization & Drug Dist Proc STEP-BD OM3.pdf Methods OM3 Qualified Researchers
Study Visit Flowsheet OM3.pdf Methods OM3 Qualified Researchers
2 RAD Randomization.pdf Methods RAD Randomization Protocol Qualified Researchers
3 PAD Randomization.pdf Methods PAD Randomization Protocol Qualified Researchers
4 REFD Randomization.pdf Methods REFD Randomization Protocol Qualified Researchers
NDCT Dictionary to STEP BD Instruments.pdf Methods Map of NDCT Dictionaries to STEP-BD Instruments Qualified Researchers
RAD_ID_STATUS_info.pdf Methods ID Status Documentation Qualified Researchers
PAD_ID_STATUS_info.pdf Methods ID Status Documentation Qualified Researchers
REFD_ID_STATUS_info.pdf Methods ID Status Documentation Qualified Researchers
SCP_ID_STATUS_info.pdf Methods ID Status Documentation Qualified Researchers
STEP-BD Overview Questions&Answers.pdf Objectives Overview Qualified Researchers
Assessment Notes STEP-BD OM3.pdf Results OM3 Qualified Researchers
Data Presentation Step-BD PCOS.pdf Results PCOS Qualified Researchers
cptf_final.xlsx Results Community Partners Tracking Form Qualified Researchers
SCP_reactivation.xlsx Results STEP-BD SCP Reactivation Form Qualified Researchers
days_well_final.xlsx Results Days Well Dataset Qualified Researchers
O3_RCP_FINAL.xlsx Results RCP_OMEGA3_FINAL Qualified Researchers
PAD_id_status.csv Results Patient's Status at each PAD Timepoint Qualified Researchers
SCP_id_status.csv Results Patient's Status at Each SCP Visit Qualified Researchers
RAD_id_status.csv Results Patient's Status at each RAD Timepoint Qualified Researchers
REFD_id_status.csv Results Patient's Status at each REFD Timepoint Qualified Researchers
CMF Pathways.pdf Other Trial Pathways Qualified Researchers
STEP-BD Protocol 09 12 2000.pdf Analysis Protocol Protocol Qualified Researchers
STEP-BD Protocol 08 17 2004 Revised.pdf Analysis Protocol Revised Protocol Qualified Researchers
Protocol STEP-BD OM3.pdf Analysis Protocol OM3 Qualified Researchers
Protocol STEP-BD PCOS.pdf Analysis Protocol PCOS Qualified Researchers



A long-term study of current treatments for bipolar disorder, including medications and psychosocial therapies. Completed NCT00012558 N01 MH80001 Gary Sachs, M.D. September 1998 September 2005
helpcenter.collection.general-tab

NDA Help Center

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.
IDNameCreated DateStatusType
No records found.
helpcenter.collection.experiments-tab

NDA Help Center

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.
ADHD Symptom Checklist Clinical Assessments 248
Adverse Events Clinical Assessments 39
Affective Disorders Evaluation Clinical Assessments 4107
Attributional Style Scale Clinical Assessments 265
Beck Depression Inventory Clinical Assessments 300
Beck Hopelessness Scale Clinical Assessments 3179
Birth Form Clinical Assessments 3
Care Satisfaction Questionnaire Clinical Assessments 3377
Care Utilization Clinical Assessments 3908
Change in Diagnosis Form Clinical Assessments 1658
Clinical Monitoring Form Clinical Assessments 3732
Clinical Trials: Inclusion/Exclusion Criteria Clinical Assessments 10
Concomitant Medications Clinical Assessments 113
Davidson Trauma Scale Clinical Assessments 310
Demographic Form Clinical Assessments 3867
Depression Entry Form Clinical Assessments 537
Dietary Questionnaire Clinical Assessments 10
Dysfunctional Attitudes Scale Clinical Assessments 285
ECG Results Clinical Assessments 39
Eating Disorder Inventory -3 Clinical Assessments 96
Edinburgh Handedness Inventory Clinical Assessments 2977
End of Study Form Clinical Assessments 2367
End of Treatment Form Clinical Assessments 376
Enrollment Form Clinical Assessments 4551
Examination Form Clinical Assessments 100
Family Contacts Clinical Assessments 3098
Family History Form Clinical Assessments 2860
Fear Questionnaire Clinical Assessments 306
Helping Alliance Questionnaire Clinical Assessments 2595
Hospitalization Form Clinical Assessments 3073
Interpersonal Support Evaluation List Clinical Assessments 283
Kennerley Blues Questionnaire Clinical Assessments 13
Lab Results Form Clinical Assessments 1776
Liebowitz Social Anxiety Scale (LSAS) Clinical Assessments 490
Life - RIFT (The Range of Impaired Functioning Tool) Clinical Assessments 3904
Life Experience Survey Clinical Assessments 3118
Medication History Clinical Assessments 2963
Menstrual History Clinical Assessments 1769
Mini International Neuropsychiatric Interview. Part I Clinical Assessments 3790
Montgomery-Asberg Depression Rating Scale Clinical Assessments 3931
NEO-Five Factor Inventory Clinical Assessments 2338
Panic Disorder Severity Scale Clinical Assessments 613
Perceived Criticism Scale Clinical Assessments 1225
Personal Diagnostic Questionnaire Clinical Assessments 2897
Pregnancy Outcome Form Clinical Assessments 67
Protocol Violators Clinical Assessments 4
Psychosocial Intervention Session Tracking Form Clinical Assessments 234
Psychosocial Therapy Exit Form Clinical Assessments 293
Quality of Life Enjoyment and Satisfaction Questionnaire Clinical Assessments 3371
Quarterly Summary Clinical Assessments 3799
Refractory Depression Randomized Care Pathway Exit Form Clinical Assessments 66
Religiosity Form Clinical Assessments 2574
Research Subject Clinical Assessments 1889
SF-36 Health Survey Clinical Assessments 2920
Serious Adverse Events Clinical Assessments 785
Social Attainment Scale Clinical Assessments 381
Social Rhythm Metric Clinical Assessments 31
Suicide Questionnaire Clinical Assessments 1468
Work Impact Clinical Assessments 3899
Yale-Brown Obsessive Compulsive Scale Clinical Assessments 256
Young Mania Rating Scale Clinical Assessments 3927
helpcenter.collection.shared-data-tab

NDA Help Center

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.

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 IDStudyTitleJournalAuthorsDateStatus
No records found.
helpcenter.collection.publications-tab

NDA Help Center

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.

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 NameAbstractCollection/Study SubjectsData UsageState
The relationship between Misuse/Abuse of Treatment and Quality of Life among Adults 18 and Over with Bipolar Disorder by Race/EthnicityThe objective of the study was to determine the relationship of misuse/abuse of pharmacological treatment and the quality of life by race/ethnicity for adults 18 and over with bipolar disorder. This was an analysis of secondary data from the Step BD project, which is a longitudinal controlled trial. Analysis was of baseline data and included 2576 subjects over the age of 18 with data for all variables of interest. The main independent variable was treatment adherence, based on reported adherence to prescribed medications. Non-adherence was defined as taking <75% of prescribed medications. Outcomes included quality of life, depression, and hopelessness, as assessed by the Quality of Life Enjoyment and Satisfaction Questionnaire, Montgomery-Asberg Depression Rating Scale, and Beck Hopelessness Scale, respectively. Descriptive and bivariate statistics were used to describe the sample, and multivarible regression analyses were used to determine the association between treatment adherence and outcomes, correcting for sociodemographics, co-morbid physical and mental health conditions, and use of psychosocial services. The majority of the sample identified as White, with approximately 5% identifying as Black/African American and 5% identifying as Hispanic. 89% of participants were adherent to prescription medication. Adherence did not differ by racial/ethnic group. In multivariable analysis, poor medication adherence was associated with a poorer quality of life score only among White patients (p=0.0014). Medication adherence was not significantly associated with hopelessness or depression scores in any racial/ethnic groups. Overall, our results provide limited evidence for associations between treatment adherence and quality of life and negative outcomes. These findings highlight the need for treatment strategies beyond pharmaceutical medication to improve the lives of people living with bipolar disorder, particularly those of minoritized racial/ethnic groups.4508/4508Secondary AnalysisShared
Identifying Clinical Net Benefit of Psychotropic Medication Use with Latent Variable Techniques: Evidence from Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD)Background: Poor medication adherence is common among individuals with Bipolar Disorder (BD). Understanding the sources of heterogeneity in clinical net benefit (CNB) and how it is related to psychotropic medications can provide new insight into ways to improve adherence. Methods: Data come from the baseline assessments of the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD). Latent class analysis identified groups of CNB, and validity of this construct was assessed using the SF-36. Adherence was defined as taking 75% or more of medications as prescribed. Associations between CNB and adherence were tested using multiple logistic regression adjusting for sociodemographic characteristics. Results: Five classes of CNB were identified: High (24%), Moderately high (12%), Moderate (26%), Moderately low (27%) and Low (12%). Adherence to psychotropic medications did not differ across classes (71% to 75%, χ2=3.43, p=0.488). Medication regimens differed by class: 57% of the High CNB were taking ≤2 medications, whereas 49% of the Low CNB were taking ≥4. CNB classes had good concordance with the SF-36. Limitations: Missing data limited measures used to define CNB. Participants’ perceptions of their illness and treatment were not assessed. Conclusions: This novel operationalization of CNB has construct validity as indicated by the SF-36. Although CNB and polypharmacy regimens are heterogeneous in this sample, adherence is similar across CNB. Studying adherent individuals, despite suboptimal CNB, may provide novel insights into aspects influencing adherence.4454/4454Secondary AnalysisShared
* Data not on individual level
helpcenter.collection.associated-studies-tab

NDA Help Center

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.
Edit