Ziprasidone in the Psychosis Prodrome (ZIP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00635700
First received: March 6, 2008
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Psychosis Prodrome
Drug: ziprasidone
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • conversion to psychosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • improvement SOPS total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: March 2008
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: ziprasidone
20-160 mg/d
Other Name: Geodon
Placebo Comparator: 2 Drug: placebo
placebo

  Eligibility

Ages Eligible for Study:   16 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • SIPS criteria for psychosis prodrome
  • clinically referred

Exclusion Criteria:

  • prolonged QTc
  • history of syncope
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00635700     History of Changes
Other Study ID Numbers: 0801003386, IIR GA1281GE
Study First Received: March 6, 2008
Last Updated: May 14, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Canada: Health Canada Clinical Trials Application control number 120085

Keywords provided by Yale University:
psychosis
schizophrenia
prodrome
ziprasidone
placebo

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on July 24, 2014