NIMH Data Archive - Data

Genomics

Neuroimaging

Phenotype¹

New Trial
Clinical Trial

¹ Numbers reported are subjects by age

New Project
Grant/Project Number

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

Collection - Use Existing Experiment

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

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

Select	Experiment Id	Experiment Name	Experiment Type	Created On

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

Collection - Add Experiment

Add Supporting Documentation

Funding Source:
URL:

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

Use/Modify Existing Data Structure

Request New Data Structure

Targeted Enrollment:

Initial Submission Date:

Initial Share Date:

Data Structure Search:

Data Structures:

Submit

Request Submission Exemption

Not Eligible

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

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

Collection Updated

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

[CMS] Error

[CMS]

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

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

Data Expected Item	Original Sharing Date	New Sharing Date

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

Explanation must be between 20 and 200 characters in length.

Please press Save or Cancel

Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) #2147

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

Collection Title	Collection Investigators	Collection Description
Collection Title:	Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD)
Collection Investigators:	Gary Sachs and Michael Thase
Collection Description:	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.
Data Repository:	NIMH Data Archive
Permission Group:
Collection Creation Date:	09/27/2015
NIH Research Initiative:	NIMH Repository & Genomics Resource (NRGR)
Collection Phase:	Funding Completed
Collection Sub-Phase:	Close Out
Blinded Clinical Trial:	No
Subjects Shared:	4,551

{"values":[]}

Loading Chart...

Funding Sources:

Funding Source Name	Funding Source URL
NIH - Contract	None

Supporting Documentation:

File Name	File Type	Description	Audience
STEP-BD Overview Questions&Answers.pdf	Objectives	Overview	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
Assessment Notes STEP-BD OM3.pdf	Results	OM3	Qualified Researchers
Documentation Summary STEP-BD OM3.pdf	Methods	OM3	Qualified Researchers
Protocol STEP-BD OM3.pdf	Analysis Protocol	OM3	Qualified Researchers
Randomization & Drug Dist Proc STEP-BD OM3.pdf	Methods	OM3	Qualified Researchers
Study Visit Flowsheet OM3.pdf	Methods	OM3	Qualified Researchers
Data Presentation Step-BD PCOS.pdf	Results	PCOS	Qualified Researchers
Protocol STEP-BD PCOS.pdf	Analysis Protocol	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
2 RAD Randomization.pdf	Methods	RAD Randomization Protocol	Qualified Researchers
PAD_id_status.csv	Results	Patient's Status at each PAD Timepoint	Qualified Researchers
3 PAD Randomization.pdf	Methods	PAD Randomization Protocol	Qualified Researchers
SCP_id_status.csv	Results	Patient's Status at Each SCP Visit	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.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
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
LtdSiteStatusSOP.7.16.041.pdf	Software	SCP Manual of Study Operations	Qualified Researchers
CMF Pathways.pdf	Other	Trial Pathways	Qualified Researchers

Grant Information:

Clinical Trials:

Brief Summary	Status	Clinical Trial ID	Study ID	Principal Investigator	Start Date	End Date
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

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
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

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
No records found.

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.

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:

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
The relationship between Misuse/Abuse of Treatment and Quality of Life among Adults 18 and Over with Bipolar Disorder by Race/Ethnicity	The 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.	4508/4508	Secondary Analysis	Shared
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.	4454/4454	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.

Contact NDA Help Desk

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