Ziprasidone in the Psychosis Prodrome (ZIP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Yale University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00635700
First received: March 6, 2008
Last updated: January 13, 2010
Last verified: January 2010
  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 ]

Estimated Enrollment: 80
Study Start Date: March 2008
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00635700

Contacts
Contact: Scott W Woods, MD 203 074 7038 scott.woods@yale.edu
Contact: John R Saksa, Psy.D. 203 974 7043 john.saksa@yale.edu

Locations
United States, California
University of California at San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Kathy Shafer    619-497-6624    kshafer@ucsd.edu   
Contact: Kristin Cadenhead, M.D.    619-725-3537    kcadenhead@ucsd.edu   
Principal Investigator: Kristin Cadenhead, M.D.         
Sub-Investigator: Nasra Haroun, M.D.         
University of California at Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Sandra De Silva, Ph.D.    310-206-6126    desilva@psych.ucla.edu   
Contact: Tyrone D Cannon, Ph.D.    310-206-8765    cannon@psych.ucla.edu   
Principal Investigator: Tyrone D Cannon, Ph.D.         
Sub-Investigator: Melita Daley, M.D.         
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Asley Lee    415-476-7560    ashleyl@Lppi.ucsf.edu   
Principal Investigator: Demian Rose, M.D., Ph.D.         
Sub-Investigator: Daniel Mathalon, M.D., Ph.D.         
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06519
Contact: Barbara Walsh, PhD    203-974-7052    barbara.walsh@yale.edu   
Contact: John R Saksa, PsyD    203 974 7043    john.saksa@yale.edu   
Principal Investigator: Scott W Woods, MD         
Sub-Investigator: Thomas McGlashan, M.D.         
Sub-Investigator: Joel Gelernter, M.D.         
United States, Georgia
Emory University Not yet recruiting
Atlanta, Georgia, United States, 30322
Contact: Joy Brasifield    404-727-7547    jbrasfi@emory.edu   
Contact: Elaine Walker, Ph.D.    404-727-7547    psyefw@emory.edu   
Principal Investigator: Elaine Walker, Ph.D.         
Sub-Investigator: Michael Compton, M.D.         
United States, Massachusetts
Beth Israel Deaconess Hospital Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Ana Carla Oltramari    781-306-8636    aoltramai@challiance.org   
Contact: Larry Seidman, Ph.D.       lseidman@bidmc.harvard.edu   
Principal Investigator: Larry Seidman, Ph.D.         
Sub-Investigator: Anthony Giuliano, Ph.D.         
Sub-Investigator: Gustavo Kinrys, M.D.         
University of Massachusetts Recruiting
Worcester, Massachusetts, United States, 01604
Contact: Lauren Yakutis    508-856-2407    lauren.yakutis@umassmed.edu   
Principal Investigator: Jean Frazier, M.D.         
United States, Michigan
Wayne State University School of Medicine Not yet recruiting
Detroit, Michigan, United States, 48201
Principal Investigator: Rajaprabhakaran Rajarethnam, M.D.         
United States, New York
North Shore, Long Island Jewish Health System Recruiting
Glen Oaks, New York, United States, 11004
Contact: Jenni Atencio, M.A.    718-470-4238    jatencio@nshs.edu   
Contact: Barbara A Cornblatt, Ph.D.    718-470-8133    cornblat@lij.edu   
Principal Investigator: Barbara A Cornblatt, Ph.D.         
Sub-Investigator: Andrea Auther, Ph.D.         
Sub-Investigator: Chris Smith, Ph.D.         
Sub-Investigator: Christoph Correll, M.D.         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Andrea Pelletier    919-843-3421    andrea_pelletier@med.unc.edu   
Contact: Karen Graham, M.D.    919-929-2311    karen_graham@unc.edu   
Principal Investigator: Karen Graham, M.D.         
Sub-Investigator: Diana Perkins, M.D.         
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N2T9
Contact: Geri Anderson    403-944-1050    geri.anderson@calgaryhealthregion.ca   
Contact: Donald Addington, M.D.    403-944-1296    addingto@ucalgary.ca   
Principal Investigator: Donald Addington, M.D.         
Sub-Investigator: Jean Addington, Ph.D.         
Sub-Investigator: Thomas Raedler, M.D.         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Scott W Woods, MD Yale University
  More Information

No publications provided

Responsible Party: Scott W. Woods, M.D., Yale University School of Medicine
ClinicalTrials.gov Identifier: NCT00635700     History of Changes
Other Study ID Numbers: 0801003386, IIR GA1281GE
Study First Received: March 6, 2008
Last Updated: January 13, 2010
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 April 17, 2014