NCT00237874

Brief Summary

We hypothesize that symptoms will improve in patients who meet diagnostic criteria for the schizophrenia prodrome when they are prescribed aripiprazole.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_2 schizophrenia

Timeline
Completed

Started Feb 2004

Typical duration for phase_2 schizophrenia

Geographic Reach
1 country

2 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

February 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

June 6, 2014

Status Verified

June 1, 2014

Enrollment Period

3 years

First QC Date

October 7, 2005

Last Update Submit

June 5, 2014

Conditions

SchizophreniaPsychosis

Keywords

prodromeultra high riskaripiprazole

Outcome Measures

Primary Outcomes (1)

  • Total Score of the Scale Of Prodromal Symptoms

    This is a 19-item scale with items scores 0-6. Treatment response is defined as all 5 Scale of Prodromal Syndromes positive symtpom items being rate below the prodromal range (\< or equal to 2).

    8 weeks

Interventions

AripiprazoleDRUG

Eligibility Criteria

Age13 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • age 13 to 40 meet criteria for the prodrome for schizophrenia

You may not qualify if:

  • history of psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institute of Living

Hartford, Connecticut, 06106, United States

Location

Yale School of Medicine

New Haven, Connecticut, 06512, United States

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Scott W Woods, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2005

First Posted

October 12, 2005

Study Start

February 1, 2004

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

June 6, 2014

Record last verified: 2014-06

Locations

US(2)