Longitudinal Multimodal Neuroimaging Studies in Patients... | NCT01688765

Studies
Longitudinal Multimodal Neuroimaging Studies in Patients With First Episode Psychosis

NCT01688765

Sponsor

Mclean Hospital

Status

Completed

Last Update Posted

Sep 27, 2022Actual

Enrollment

187Actual

Phase

Not provided

Conditions

Psychotic Disorders

Interventions

Observational

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 17, 2012Actual

Primary Completion Date

Sep 23, 2022Actual

Completion Date

Sep 23, 2022Actual

First Submitted Date

Sep 17, 2012

First Submission Date that Met QC Criteria

Sep 17, 2012

First Posted Date

Sep 20, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2022

Last Update Posted Date

Sep 27, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to investigate the structural, functional and chemical brain abnormalities in patients with first episode psychosis and assess the evolution of these abnormalities during the course of the disease.

Detailed Description

The study design is case-control, there are no interventions.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

187Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
First Episode Psychosis Patients		Individuals experiencing a first episode of psychosis	Other: Observational
Healthy Controls		Psychiatrically healthy individuals	Other: Observational

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observational	Other		First Episode Psychosis Patients Healthy Controls

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of first episode of a psychotic disorder
Healthy controls with no psychiatric disorder history

Exclusion Criteria:

Significant neurological or medical illness history
Ages <18 or >45

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

First episode psychosis patients Healthy controls

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dost Ongur, MD PhD	Mclean Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
McLean Hospital		Belmont	Massachusetts	02478	United States

Condition Browse Module

MeSH Terms

ID	Term
D011618	Psychotic Disorders
D012559	Schizophrenia
D001714	Bipolar Disorder

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D057832	Watchful Waiting

Ancestor Terms

ID	Term
D017063	Outcome Assessment, Health Care
D010043	Outcome and Process Assessment, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration

Browse Leaves

Not provided

Browse Branches

Not provided