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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05905003




Registration number
NCT05905003
Ethics application status
Date submitted
17/05/2023
Date registered
15/06/2023

Titles & IDs
Public title
AMP SCZ® Observational Study: PREDICT-DPACC
Scientific title
Accelerating Medicines Partnership® Schizophrenia Observational Study: Psychosis Risk Evaluation, Data Integration, and Computational Technologies -Data Processing, Analysis, and Coordination Center and Coordination Center
Secondary ID [1] 0 0
U24MH124629
Secondary ID [2] 0 0
2020P002267
Universal Trial Number (UTN)
Trial acronym
AMP SCZ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clinical High Risk 0 0
Psychosis 0 0
Remission 0 0
Conversion 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
CHR - Clinical High Risk (CHR) for psychosis subjects meeting diagnostic criteria for CHR on the Positive SYmptoms and Diagnostic Criteria for the CAARMS Harmonized with the SIPS (PSYCHS).

HC - Healthy Control (HC) Subjects
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Conversion to Psychosis
Timepoint [1] 0 0
By 24 month follow-up.
Secondary outcome [1] 0 0
Remission
Timepoint [1] 0 0
By 24 month follow-up.
Secondary outcome [2] 0 0
Non-conversion/Non-remission
Timepoint [2] 0 0
By 24 month follow-up.

Eligibility
Key inclusion criteria
* Individuals between 12 and 30 years old;
* Understand and sign an informed consent (or assent for minors) document;
* Meet diagnostic criteria for CHR from the Positive SYmptoms and Diagnostic Criteria for the CAARMS Harmonized with the SIPS (PSYCHS).
Minimum age
12 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Antipsychotic medication exposure equivalent to a total lifetime haloperidol dose of >50 mg or current antipsychotic medication at time of screening assessment;
* Documented history of intellectual disability;
* Past or current clinically relevant central nervous system disorder;
* Traumatic brain injury that is rated as 7 or above on the Traumatic Brain Injury screening instrument;
* Current or past treated or untreated psychotic episode, as determined using the PSYCHS.

See also the AMP SCZ website link for a description of eligibility criteria (https://www.ampscz.org/participate/eligible/).

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/05/2025
Actual
Sample size
Target
2617
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
HEP and co-located Headspace Adelaide - Adelaide
Recruitment hospital [2] 0 0
Headspace, Craigieburn - Craigieburn
Recruitment hospital [3] 0 0
Headspace, Glenroy - Glenroy
Recruitment hospital [4] 0 0
Headspace Melton - Melton South
Recruitment hospital [5] 0 0
Orygen Specialist Programs, Melbourne - Parkville
Recruitment hospital [6] 0 0
Headspace, Sunshine - Sunshine
Recruitment hospital [7] 0 0
Headspace, Werribee - Werribee
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3064 - Craigieburn
Recruitment postcode(s) [3] 0 0
3046 - Glenroy
Recruitment postcode(s) [4] 0 0
3338 - Melton South
Recruitment postcode(s) [5] 0 0
3122 - Parkville
Recruitment postcode(s) [6] 0 0
3020 - Sunshine
Recruitment postcode(s) [7] 0 0
3030 - Werribee
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
Canada
State/province [11] 0 0
Alberta
Country [12] 0 0
Canada
State/province [12] 0 0
Quebec
Country [13] 0 0
Chile
State/province [13] 0 0
Región Metropolitana
Country [14] 0 0
China
State/province [14] 0 0
Shanghai
Country [15] 0 0
Denmark
State/province [15] 0 0
Copenhagen
Country [16] 0 0
Germany
State/province [16] 0 0
Brescia
Country [17] 0 0
Germany
State/province [17] 0 0
Thuringia
Country [18] 0 0
Germany
State/province [18] 0 0
Munich
Country [19] 0 0
Hong Kong
State/province [19] 0 0
Hong Kong
Country [20] 0 0
Italy
State/province [20] 0 0
Pavia
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Gwangju
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Seoul
Country [23] 0 0
Singapore
State/province [23] 0 0
Singapore
Country [24] 0 0
Spain
State/province [24] 0 0
Madrid
Country [25] 0 0
Switzerland
State/province [25] 0 0
Lausanne
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Birmingham
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Cambridge
Country [28] 0 0
United Kingdom
State/province [28] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
Brigham and Women's Hospital
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Orygen
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Yale University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Government body
Name [3] 0 0
National Institute of Mental Health (NIMH)
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Martha E Shenton, Ph.D.
Address 0 0
Brigham and Women's Hospital/Harvard Medical School
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Martha E Shenton, Ph.D.
Address 0 0
Country 0 0
Phone 0 0
617-699-6152
Fax 0 0
Email 0 0
shenton@bwh.harvard.edu
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
AMP SCZ will be collecting a wide range of data types as described below:

* Ascertainment \& outcome measures - will be stored as tabular data (multiple formats possible, csv)
* Neurocognitive measures - will be stored as tabular data (multiple formats possible, csv)
* EEG data
* MRI data
* Audio/Video data
* Digital Biomarkers (EMA) including

* Phone Surveys
* Phone GPS
* Phone Accelerometry
* Phone Audio diary
* Watch/sensor actigraphy (captured by an Axivity device)
* Genetics \& Fluid Biomarkers metadata forms

Data will include QCed raw data as well as processed data and derivatives. Sensitive data will be identified and separated from non-sensitive data.

Data sharing will be consistent with subject consent data use limitations.

Supporting document/s available: Study protocol
When will data be available (start and end dates)?
NIMH Data Archive (NDA) Curated Release Environment. Curated releases will be made available to the larger research community approximately every 6 months. The Psychosis Risk Evaluation, Data Integration, and Computational Technologies (PREDICT) Data Processing, Analysis and Coordination Center (PREDICT-DPACC) will be responsible for packaging the data from the project that will be shared in curated releases and submitted to the NDA. This will follow standard NDA procedures with all NDA dictionaries and NDA QA/QC protocols. Data will include QCed raw data as well as processed data and derivatives. Sensitive data will be identified and separated from non-sensitive data. Qualified researchers will need to submit a Data Access Request to the NDA to see these data. The PREDICT-DPACC will not be responsible for granting access to these data on the NDA. NDA may decide to require separate agreements for sensitive vs non-sensitive data.
Available to whom?
For accessing data on the NDA please see https://nda.nih.gov/ampscz/access-data-info.html
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://nda.nih.gov/ampscz/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05905003