NCT01688765

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
187

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2012

Completed
27 days until next milestone

Study Start

First participant enrolled

October 17, 2012

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2022

Completed
Last Updated

September 27, 2022

Status Verified

September 1, 2022

Enrollment Period

9.9 years

First QC Date

September 17, 2012

Last Update Submit

September 24, 2022

Conditions

Psychotic Disorders

Keywords

SchizophreniaSchizoaffective disorderBipolar disorder

Study Arms (2)

First Episode Psychosis Patients

Individuals experiencing a first episode of psychosis

Other: Observational

Healthy Controls

Psychiatrically healthy individuals

Other: Observational

Interventions

ObservationalOTHER
First Episode Psychosis PatientsHealthy Controls

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

First episode psychosis patients Healthy controls

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Psychotic DisordersSchizophreniaBipolar Disorder

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood Disorders

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Dost Ongur, MD PhD

    Mclean Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D, PhD, Clinical Director

Study Record Dates

First Submitted

September 17, 2012

First Posted

September 20, 2012

Study Start

October 17, 2012

Primary Completion

September 23, 2022

Study Completion

September 23, 2022

Last Updated

September 27, 2022

Record last verified: 2022-09

Locations

US(1)