Ziprasidone in the Psychosis Prodrome

Phase 2

Completed

• Conditions: Psychosis Prodrome
• Interventions: Drug: placebo; Drug: ziprasidone

• Registration Number: NCT00635700
• Lead Sponsor: Yale University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-06
• Study First Submitted QC: 2008-03-13
• Study First Posted: 2008-03-14
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Results First Submitted: 2016-09-06
• Results First Submitted QC: 2016-09-06
• Results First Posted: 2016-10-27
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-03
• Last Update Posted: 2023-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Patients will be treated with placebo for 6 months
Ziprasidone	ziprasidone	Patients will be treated with Ziprasidone for 6 months

Primary Outcome Measures

Name	Time	Method
Conversion to Psychosis	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in Scale of Psychosis-risk Symptoms Total Score	baseline and 8 weeks	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.

Trial Locations

Locations (11)

University of California at Los Angeles; 🇺🇸 Los Angeles, California, United States

Beth Israel Deaconess Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Massachusetts; 🇺🇸 Worcester, Massachusetts, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

University of Calgary; 🇨🇦 Calgary, Alberta, Canada

University of California at San Diego; 🇺🇸 La Jolla, California, United States

Emory University; 🇺🇸 Atlanta, Georgia, 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