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Ziprasidone in the Psychosis Prodrome (ZIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00635700
Recruitment Status : Completed
First Posted : March 14, 2008
Results First Posted : October 27, 2016
Last Update Posted : October 27, 2016
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Psychosis Prodrome Drug: ziprasidone Drug: placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ziprasidone vs Placebo in the Prevention of Psychosis Among Symptomatic Adolescents and Young Adults at Prodromal Risk
Study Start Date : March 2008
Primary Completion Date : November 2012
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: ziprasidone
20-160 mg/d
Other Name: Geodon
Placebo Comparator: 2 Drug: placebo
placebo


Outcome Measures

Primary Outcome Measures :
  1. Conversion to Psychosis [ Time Frame: 6 months ]
    Conversion to psychosis according to the SIPS require psychotic symptom severity ratings in the frankly psychotic range, along with meeting persistence or urgency criteria.


Secondary Outcome Measures :
  1. Improvement SOPS Total Score [ Time Frame: 8 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • SIPS criteria for psychosis prodrome
  • clinically referred

Exclusion Criteria:

  • prolonged QTc
  • history of syncope
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00635700


Locations
United States, California
University of California at San Diego
La Jolla, California, United States, 92093
University of California at Los Angeles
Los Angeles, California, United States, 90095
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06519
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Beth Israel Deaconess Hospital
Boston, Massachusetts, United States, 02215
University of Massachusetts
Worcester, Massachusetts, United States, 01604
United States, Michigan
Wayne State University School of Medicine
Detroit, Michigan, United States, 48201
United States, New York
North Shore, Long Island Jewish Health System
Glen Oaks, New York, United States, 11004
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N2T9
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Scott W Woods, MD Yale University
More Information

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00635700     History of Changes
Other Study ID Numbers: 0801003386
IIR GA1281GE
First Posted: March 14, 2008    Key Record Dates
Results First Posted: October 27, 2016
Last Update Posted: October 27, 2016
Last Verified: September 2016

Keywords provided by Yale University:
psychosis
schizophrenia
prodrome
ziprasidone
placebo

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents