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OpenTrials
Completed

NCT Number: NCT00237874

Aripiprazole Treatment of Prodromal Patients

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

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Key information

Conditions

Schizophrenia Mental Disorders Psychosis Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

13 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Institute of Living, Hartford, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • history of psychosis

Treatment and study plan

Aripiprazole

Drug

Primary outcomes

  1. Total Score of the Scale Of Prodromal Symptoms

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Oct 12, 2005
Registry last updated
Jun 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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