Aripiprazole Treatment of Prodromal Patients

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00237874

Enrollment

Registered

2005-10-12

Start date

2004-02-29

Completion date

2007-02-28

Last updated

2014-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychosis, Schizophrenia

Keywords

prodrome, ultra high risk, aripiprazole

Brief summary

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

Detailed description

This is an 8 week trial with extension for responders out to one year. All patients receive active medication; there is no placebo. Patients must meet criteria for the schizophrenia prodrome according to the Structured Interview for Prodromal Syndromes. Patients receive counseling as well. All counseling and medication are free of charge.

Interventions

DRUGAripiprazole

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

13 Years to 40 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* history of psychosis

Design outcomes

Primary

Measure	Time frame	Description
Total Score of the Scale Of Prodromal Symptoms	8 weeks	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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026