NCT00291200

Brief Summary

This study will gather information on the natural history of the basic symptoms of psychosis to identify factors that may affect the improvement or persistence of the symptoms.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
268

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2003

Longer than P75 for all trials

Geographic Reach
2 countries

3 active sites

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

Study Start

First participant enrolled

August 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 13, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

June 10, 2014

Status Verified

June 1, 2014

Enrollment Period

5.5 years

First QC Date

February 10, 2006

Last Update Submit

June 9, 2014

Conditions

SchizophreniaPsychotic Disorders

Keywords

PsychosisBasic Symptoms

Outcome Measures

Primary Outcomes (2)

  • Information on the natural history of basic symptoms of psychosis

    Measured monthly during Year 1; every 2 months during Year 2; and every 3 months during Years 3, 4, and 5

  • Factors that may affect the improvement or persistence of basic symptoms of psychosis

    Measured monthly during Year 1; every 2 months during Year 2; and every 3 months during Years 3, 4, and 5

Study Arms (2)

1

Participants with basic symptoms of psychosis

2

Control participants

Eligibility Criteria

Age12 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

The study population consists of participants who meet the basic symptoms for psychosis and control participants recruited at three sites: the PRIME Clinics at University of North Carolina, Yale University, and the Center for Addiction and Mental Health (CAMH) in Toronto, Canada.

You may qualify if:

  • Meets modified criteria of prodromal syndromes (COPS) for schizophrenia prodrome or help-seeking control

You may not qualify if:

  • History of psychosis
  • Antipsychotic treatment in the month prior to study entry
  • More than 16 weeks of lifetime antipsychotic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Prevention through Risk Identification Management and Education (PRIME) Clinic

New Haven, Connecticut, 06519, United States

Location

PRIME Clinic

Chapel Hill, North Carolina, 27599, United States

Location

PRIME Clinic

Toronto, Ontario, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for routine laboratory studies

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Scott W. Woods, MD

    Yale University

    PRINCIPAL INVESTIGATOR

  • Jean Addington, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

  • Diana O. Perkins, MD, MPH

    University of North Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2006

First Posted

February 13, 2006

Study Start

August 1, 2003

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

June 10, 2014

Record last verified: 2014-06

Locations

US(2)CA(1)