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

March 6, 2008
May 14, 2014
March 2008
November 2012   (final data collection date for primary outcome measure)
conversion to psychosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00635700 on ClinicalTrials.gov Archive Site
improvement SOPS total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Ziprasidone in the Psychosis Prodrome
Ziprasidone vs Placebo in the Prevention of Psychosis Among Symptomatic Adolescents and Young Adults at Prodromal Risk

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Psychosis Prodrome
  • Drug: ziprasidone
    20-160 mg/d
    Other Name: Geodon
  • Drug: placebo
    placebo
  • Experimental: 1
    Intervention: Drug: ziprasidone
  • Placebo Comparator: 2
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
November 2012
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • SIPS criteria for psychosis prodrome
  • clinically referred

Exclusion Criteria:

  • prolonged QTc
  • history of syncope
Both
16 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00635700
0801003386, IIR GA1281GE
Yes
Yale University
Yale University
Not Provided
Principal Investigator: Scott W Woods, MD Yale University
Yale University
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP