NCT00635700

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2008

Longer than P75 for phase_2

Geographic Reach
2 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 14, 2008

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
4 years until next milestone

Results Posted

Study results publicly available

October 27, 2016

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

4.7 years

First QC Date

March 6, 2008

Results QC Date

September 6, 2016

Last Update Submit

March 3, 2023

Conditions

Psychosis Prodrome

Keywords

psychosisschizophreniaprodromeziprasidoneplacebo

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in Scale of Psychosis-risk Symptoms Total Score

    baseline and 8 weeks

Study Arms (2)

Ziprasidone

EXPERIMENTAL

Patients will be treated with Ziprasidone for 6 months

Drug: ziprasidone

Placebo

PLACEBO COMPARATOR

Patients will be treated with placebo for 6 months

Drug: placebo

Interventions

ziprasidoneDRUG

20-160 mg/d

Also known as: Geodon
Ziprasidone
placeboDRUG

placebo

Placebo

Eligibility Criteria

Age16 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • prolonged corrected QT interval
  • history of syncope

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

University of California at San Diego

La Jolla, California, 92093, United States

Location

University of California at Los Angeles

Los Angeles, California, 90095, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06519, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Beth Israel Deaconess Hospital

Boston, Massachusetts, 02215, United States

Location

University of Massachusetts

Worcester, Massachusetts, 01604, United States

Location

Wayne State University School of Medicine

Detroit, Michigan, 48201, United States

Location

North Shore, Long Island Jewish Health System

Glen Oaks, New York, 11004, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

University of Calgary

Calgary, Alberta, T2N2T9, Canada

Location

MeSH Terms

Conditions

Psychotic DisordersSchizophrenia

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Results Point of Contact

Title
Scott W. Woods, M.D.
Organization
Yale University
scott.woods@yale.edu
203-974-7038

Study Officials

  • Scott W Woods, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2008

First Posted

March 14, 2008

Study Start

March 1, 2008

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

March 27, 2023

Results First Posted

October 27, 2016

Record last verified: 2023-03

Locations

CA(1)US(10)