NIMH Data Archive - Data

Genomics

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Phenotype¹

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Clinical Trial

¹ Numbers reported are subjects by age

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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

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Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) for Schizophrenia #2081

General
Experiments (0)
Shared Data
Publications (0)
Associated Studies (6)

Collection Title	Collection Investigators	Collection Description
Collection Title:	Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) for Schizophrenia
Collection Investigators:	Jeffrey A Lieberman
Collection Description:	The CATIE Schizophrenia Trial is a randomized controlled trial of 1600 patients with schizophrenia involving the following medications: perphenazine, fluphenazine decanoate, clozapine, olanzapine, quetiapine, risperidone and ziprasidone (which was activated in February 2002). Patients will be followed for 18 months and rerandomized to a new treatment in the event of treatment failure.
Data Repository:	NIMH Data Archive
Permission Group:
Collection Creation Date:	05/01/2014
NIH Research Initiative:	NIMH Repository & Genomics Resource (NRGR)
Collection Phase:	Funding Completed
Collection Sub-Phase:	Close Out
Blinded Clinical Trial:	No
Subjects Shared:	1,460

{"values":[]}

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Funding Sources:

Funding Source Name	Funding Source URL
NIH - Contract	None

Supporting Documentation:

File Name	File Type	Description	Audience
drug_concentration.xlsx	Methods	PK Drug Concentration, mg	Qualified Researchers
VISIT.csv	Methods	Visit Information	Qualified Researchers
Clinical Trial Design.pdf	Methods	Trial Design	Qualified Researchers
SOE_Follow-up Phase.pdf	Methods	Schedule of Events on Follow Up	Qualified Researchers
SOE.pdf	Methods	Schedule of Events	Qualified Researchers
eCRFs.pdf	Methods	Study Forms	Qualified Researchers
CATIE-Sz Protocol.pdf	Methods	Study Protocol	Qualified Researchers
Clinical Trial Overview.pdf	Objectives	Overview	Qualified Researchers
Forms List.xlsx	Other	Forms mapping to NDCT Data Dictionary	Qualified Researchers

Grant Information:

Clinical Trials:

Brief Summary	Status	Clinical Trial ID	Study ID	Principal Investigator	Start Date	End Date
The CATIE Schizophrenia Trial is part of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Project. The schizophrenia trial is being conducted to determine the long-term effects and usefulness of antipsychotic medications in persons with schizophrenia. It is designed for people with schizophrenia who may benefit from a medication change. The study involves the newer atypical antipsychotics (olanzapine, quetiapine, risperidone, clozapine, and ziprasidone)and the typical antipsychotics (perphenazine and fluphenazine decanoate). All participants will receive an initial comprehensive medical and psychiatric evaluation and will be closely followed throughout the study. For most participants the study will last up to 18 months. Everyone in the study will be offered an educational program about schizophrenia and family members will be encouraged to participate.	Completed	NCT00014001	N01 MH090001-06	Jeffrey A Lieberman, MD	December 2000	December 2004

helpcenter.collection.general-tab

Collection - General Tab

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

Collection Title
Investigators
Collection Description
Collection Phase
Funding Source
Clinical Trials

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

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

Blinded Clinical Trial Status:

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

Funding Source

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

Supporting Documentation

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

Grant Information

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

Clinical Trials

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

Frequently Asked Questions

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

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

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

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

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

Glossary

Administrator Privilege

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

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

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

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

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

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

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

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

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

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

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

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

Contact NDA Help Desk

ID	Name	Created Date	Status	Type
No records found.

helpcenter.collection.experiments-tab

Collection - Experiments

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

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

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

Frequently Asked Questions

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

Glossary

Experiment Status

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

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

Contact NDA Help Desk

Shared Data:

Title	Type	Number of Subjects
Abnormal Involuntary Movement Scale	Clinical Assessments	1452
Adverse Events - Spontaneously Reported/Systematic Inquiry	Clinical Assessments	1451
Calgary Depression Rating Scale	Clinical Assessments	1451
Cataract Assessment	Clinical Assessments	1307
Clinical Global Impression of Severity	Clinical Assessments	1452
Concomitant Medications	Clinical Assessments	1449
Demographics and Baseline Characteristics	Clinical Assessments	1458
Dose Compliance Variables	Clinical Assessments	1460
Drug Attitude Inventory	Clinical Assessments	1445
ECG Results	Clinical Assessments	1457
End of Phase Form	Clinical Assessments	1460
End of Study Form	Clinical Assessments	1460
Family Interview	Clinical Assessments	753
Hair Drug Test	Clinical Assessments	1310
Insight and Treatment Attitudes Questionnaire	Clinical Assessments	1448
Lab Results	Clinical Assessments	1460
MacArthur Competency Assessment	Clinical Assessments	1460
MacArthur Violence Assessment	Clinical Assessments	1449
Medical Diagnoses	Clinical Assessments	1451
Medical Outcomes Survey SF-12	Clinical Assessments	1447
Medication Dispensing Record	Clinical Assessments	1460
Neurocognitive Battery	Clinical Assessments	1434
Phase Discontinuation Variables	Clinical Assessments	1460
Protocol Violators	Clinical Assessments	1460
Quality of Life	Clinical Assessments	1450
Research Subject	Clinical Assessments	1458
Screening Form	Clinical Assessments	1460
Serious Adverse Events	Clinical Assessments	442
Service Utilization and Resources Monthly Form for Schizophrenia	Clinical Assessments	1449
Service Utilization and Resources Quarterly Form for Schizophrenia	Clinical Assessments	1447
Structured Clinical Interview for DSM-IV: Psychiatric History	Clinical Assessments	1460
Structured Clinical Interview for the Positive and Negative Syndrome Scale	Clinical Assessments	1450
Treatment Variables	Clinical Assessments	1460
Vital Signs	Clinical Assessments	1459

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.

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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:

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 Frequency of Symptom-Based Phenotypes of Mental Disorders is Long-Tailed	The heterogeneity of symptoms among individuals diagnosed with the same mental disorder has been blamed to hinder research in mental health and the development of effective treatments. Although widely acknowledged as problematic, the characteristics of this heterogeneity are largely unknown. We assessed the frequency of symptom phenotypes across a variety of clinical and non-clinical populations and found a consistent, long-tailed distribution. This distribution represents a mixture of a few very commonly expressed phenotypes and the sum of many, each only rarely displayed ones. As a consequence, the non-normality of this distribution induces a systematic bias, affecting all research and treatments relying on a symptom-based definition of mental disorders.	1450/5743	Secondary Analysis	Shared
Antipsychotic Adherence and Weight Change	Background: The relationship between weight change and adherence to antipsychotic medications in the treatment of schizophrenia is unclear. Methods: We used limited-access data from the Clinical Antipsychotic Trials of Intervention Effectiveness Project Schizophrenia Trial (CATIE-Sz) to estimate survival models predicting time to first and repeated discontinuation/switch of antipsychotics during the first 48 weeks of follow-up in CATIE-Sz. Explanatory variables included lagged percentage weight changes, lagged changes in Positive and Negative Syndrome Scale (PANSS) total scores, a lagged weight change/PANSS total score change interaction term, and other covariates that have been found to be associated with time to discontinuation/switch. Results: Data from 1,148 participants were included in the analysis. 692 (60.3%) had a first discontinuation/switch during the 48 weeks and median time to discontinuation/switch was 197 days. For both first and repeated events, PANSS total score change (first event HR 1.37 per 10-point change, P<0.001, repeated event HR 1.34, P<0.001) was a significant predictor of longer time to discontinuation/switch while percentage weight change (first event HR 1.04 per 10 percent change, P=0.41; repeated event HR 1.04, P=0.46) was not. The Wald test for interaction was significant (P=0.0001) and the interaction’s hazard ratio was 1.12 for first and repeated events, P=0<0.001. Age (HR 0.89 per 10-year change, P=0.002), baseline PANSS score (HR 1.23 per 10-point change, P<0.001), previous antipsychotic use (HR 1.30, P=0.003), and previous hospitalization (HR 1.09, P=0.02) were also significant predictors. Discussion: Weight change had a mixed effect on time to discontinuation/switch through its interaction with PANSS total score change, significantly increasing time to discontinuation/ switch for some and decreasing it for others. Participants with the best responses – decreases in both PANSS scores and weight – to antipsychotics were among those for whom time to discontinuation/switch was increased.	1460/1460	Secondary Analysis	Shared
Long-term Waist Circumference Changes with Olanzapine Treatment: A post-hoc analysis of CATIE Phase I Data	This study explores changes in waist circumference in patients with schizophrenia who were treated with olanzapine in the Clinical Antipsychotic Trial of Intervention Effectiveness (CATIE) study. In the CATIE study, 1493 patients were randomized to treatment with olanzapine, quetiapine, risperidone, perphenazine and later ziprasidone for up to 18 months. The primary outcome measure was time to all cause discontinuation. Olanzapine showed the lowest overall rate of discontinuation, but the highest rate of discontinuation due to weight gain or metabolic reasons. Over the 18 month trial, olanzapine was associated with the highest total weight gain and rate of weight gain compared to the other antipsychotics tested. Waist circumference was collected as a measure in this study but by-visit changes in waist circumference for the olanzapine treatment arm have not been previously reported. This study assesses the by-visit changes in waist circumference for patients treated with olanzapine over the18-month treatment period.	1460/1460	Secondary Analysis	Shared
Bifactor Model of Cognition in Schizophrenia: Evidence for General and Specific Abilities	Background: Despite extensive study of cognition in schizophrenia, it remains unclear as to whether cognitive deficits and their latent structure are best characterized as reflecting a generalized deficit, specific deficits, or some combination of general and specific constructs. Method: To clarify latent structure of cognitive abilities, confirmatory factor analysis was used to examine the latent structure of cognitive data collected for the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) for Schizophrenia study. Baseline assessment data (n = 813) were randomly divided into calibration (n = 413) and cross-validation samples (n = 400). To examine whether generalized or specific deficit models provided better explanation of the data, we estimated first-order, hierarchical, and bifactor models. Results: A bifactor model with seven specific factors and one general factor provided the best fit to the data for both the calibration and cross-validation samples. Conclusions: These findings lend support for a replicable bifactor model of cognition in schizophrenia, characterized by both a general cognitive factor and specific domains. This suggests that cognitive deficits in schizophrenia might be best understood by separate general and specific contributions.	813/813	Secondary Analysis	Shared
Causal Pathways to Social and Occupational Functioning in the First Episode of Schizophrenia: Uncovering Unmet Treatment Needs	We aimed to identify unmet treatment needs for improving social and occupational functioning in early schizophrenia using a data-driven causal discovery analysis. Demographic, clinical, and psychosocial measures were obtained for 279 participants from the Recovery After an Initial Schizophrenia Episode Early Treatment Program (RAISE-ETP) trial at baseline and six-months, along with measures of social and occupational functioning from the Quality of Life Scale. The Greedy Fast Causal Inference algorithm was used to learn a partial ancestral graph modeling causal relationships across baseline variables and six-month functioning. Effect sizes were estimated using a structural equation model. Results were validated in an independent dataset (N=187). In the data-generated model, greater baseline socio-affective capacity was a cause of greater baseline motivation (ES = 0.77), and motivation was a cause of greater baseline social and occupational functioning (ES = 1.5 and 0.96, respectively), which in turn were causes of their own six-month outcomes. Six-month motivation was also identified as a cause of occupational functioning (ES = 0.92). Cognitive impairment and duration of untreated psychosis were not direct causes of functioning at either timepoint. The graph for the validation dataset was less determinate, but otherwise supported the findings. Results from our data-generated model suggest baseline socio-affective capacity and motivation may be the most direct causes of occupational and social functioning six months after entering treatment in early schizophrenia. These findings indicate that social cognitive abilities and motivation are specific high-impact treatment needs that must be addressed in order to promote optimal social and occupational recovery.	187/591	Secondary Analysis	Shared
Deep Learning Methods applied to Drug Concentration Prediction of Olanzapine from the CATIE Trials	Pharmacometrics and the utilization of population pharmacokinetics play an integral role in model-informed drug discovery and development (MIDD). Recently, there has been a growth in the application of deep learning approaches to aid in areas within MIDD. In this study, a deep learning model, LSTM-ANN, was developed to predict olanzapine drug concentrations from the CATIE study. A total of 1,527 olanzapine drug concentrations from 523 individuals along with eleven patient-specific covariates were used in model development. The hyperparameters of the LSTM-ANN model were optimized through a Bayesian optimization algorithm. A population pharmacokinetic model using the NONMEM model was constructed as a reference to compare to the performance of the LSTM-ANN model. The RMSE of the LSTM-ANN model was 29.566 in the validation set, while the RMSE of the NONMEM model was 31.129. Permutation importance revealed age, sex, and smoking were highly influential covariates in the LSTM-ANN model. The LSTM-ANN model showed potential in the application of drug concentration predictions as it was able to capture the relationships within a sparsely sampled pharmacokinetic dataset and perform comparably to the NONMEM model.	405/522	Secondary Analysis	Shared

* Data not on individual level

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Collection - Associated Studies

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

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

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

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

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Associated Studies Tab

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

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