Ziprasidone in the Psychosis Prodrome

Psychosis Prodrome Clinical Trial

— ZIP  

Official title:

Ziprasidone vs Placebo in the Prevention of Psychosis Among Symptomatic Adolescents and Young Adults at Prodromal Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00635700
• Other study ID #: 0801003386
• Secondary ID: IIR GA1281GE
• Status: Completed
• Phase: Phase 2
• Start date: March 2008
• Est. completion date: November 2012

Study information

• Verified date: March 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to determine whether ziprasidone is superior to placebo over 24 weeks for patients with the psychosis prodrome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 40 Years

Eligibility

Inclusion Criteria:

• Structured Interview for Psychosis-risk Syndromes criteria for Clinical High Risk for Psychosis

• clinically referred

Exclusion Criteria:

• prolonged corrected QT interval

• history of syncope

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis Prodrome
• Psychotic Disorders

Intervention

Drug:
• ziprasidone
20-160 mg/d
• placebo
placebo

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
United States	Emory University	Atlanta	Georgia
United States	Beth Israel Deaconess Hospital	Boston	Massachusetts
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Wayne State University School of Medicine	Detroit	Michigan
United States	North Shore, Long Island Jewish Health System	Glen Oaks	New York
United States	University of California at San Diego	La Jolla	California
United States	University of California at Los Angeles	Los Angeles	California
United States	Yale University School of Medicine	New Haven	Connecticut
United States	University of California, San Francisco	San Francisco	California
United States	University of Massachusetts	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conversion to Psychosis	Conversion to psychosis according to the Structured Interview for Psychosis-risk Syndromes (SIPS) require psychotic symptom severity ratings in the frankly psychotic range, along with meeting persistence or urgency criteria.	6 months
Secondary	Change in Scale of Psychosis-risk Symptoms Total Score	The Scale of Psychosis-risk Symptoms, a 19-item scale with items scored 0-6. Positive Symptom scores on the SOPS in the 1 to 2 range are considered non-prodromal. Scores of 6 are considered psychotic. Scores in the 3 to 5 range are considered at the clinical high risk level. Minimum value 0. Maximum value 114. Higher score means worse outcome.	baseline and 8 weeks