Ziprasidone in the Psychosis Prodrome

NCT ID: NCT00635700

Last Updated: 2023-03-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2012-11-30

Brief Summary

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

Detailed Description

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Conditions

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Psychosis Prodrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ziprasidone

Patients will be treated with Ziprasidone for 6 months

Group Type EXPERIMENTAL

ziprasidone

Intervention Type DRUG

20-160 mg/d

Placebo

Patients will be treated with placebo for 6 months

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo

Interventions

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ziprasidone

20-160 mg/d

Intervention Type DRUG

placebo

placebo

Intervention Type DRUG

Other Intervention Names

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Geodon

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Scott W Woods, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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University of California at San Diego

La Jolla, California, United States

Site Status

University of California at Los Angeles

Los Angeles, California, United States

Site Status

University of California, San Francisco

San Francisco, California, United States

Site Status

Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Beth Israel Deaconess Hospital

Boston, Massachusetts, United States

Site Status

University of Massachusetts

Worcester, Massachusetts, United States

Site Status

Wayne State University School of Medicine

Detroit, Michigan, United States

Site Status

North Shore, Long Island Jewish Health System

Glen Oaks, New York, United States

Site Status

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

University of Calgary

Calgary, Alberta, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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IIR GA1281GE

Identifier Type: -

Identifier Source: secondary_id

0801003386

Identifier Type: -

Identifier Source: org_study_id

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