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Ziprasidone in the Psychosis Prodrome (ZIP)

Primary Purpose

Psychosis Prodrome

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ziprasidone
placebo
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis Prodrome focused on measuring psychosis, schizophrenia, prodrome, ziprasidone, placebo

Eligibility Criteria

16 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • SIPS criteria for psychosis prodrome
  • clinically referred

Exclusion Criteria:

  • prolonged QTc
  • history of syncope

Sites / Locations

  • University of California at San Diego
  • University of California at Los Angeles
  • University of California, San Francisco
  • Yale University School of Medicine
  • Emory University
  • Beth Israel Deaconess Hospital
  • University of Massachusetts
  • Wayne State University School of Medicine
  • North Shore, Long Island Jewish Health System
  • University of North Carolina
  • University of Calgary

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ziprasidone

Placebo

Arm Description

Patients will be treated with Ziprasidone for 6 months

Patients will be treated with placebo for 6 months

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 6, 2008
Last Updated
March 3, 2023
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT00635700
Brief Title
Ziprasidone in the Psychosis Prodrome
Acronym
ZIP
Official Title
Ziprasidone vs Placebo in the Prevention of Psychosis Among Symptomatic Adolescents and Young Adults at Prodromal Risk
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis Prodrome
Keywords
psychosis, schizophrenia, prodrome, ziprasidone, placebo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ziprasidone
Arm Type
Experimental
Arm Description
Patients will be treated with Ziprasidone for 6 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will be treated with placebo for 6 months
Intervention Type
Drug
Intervention Name(s)
ziprasidone
Other Intervention Name(s)
Geodon
Intervention Description
20-160 mg/d
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Conversion to Psychosis
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in Scale of Psychosis-risk Symptoms Total Score
Description
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.
Time Frame
baseline and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott W Woods, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California at San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
University of California at Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Beth Israel Deaconess Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Massachusetts
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01604
Country
United States
Facility Name
Wayne State University School of Medicine
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
North Shore, Long Island Jewish Health System
City
Glen Oaks
State/Province
New York
ZIP/Postal Code
11004
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N2T9
Country
Canada

12. IPD Sharing Statement

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Ziprasidone in the Psychosis Prodrome

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