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Ziprasidone in the Psychosis Prodrome (ZIP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00635700
First Posted: March 14, 2008
Last Update Posted: October 27, 2016
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.
Information provided by (Responsible Party):
Yale University
March 6, 2008
March 14, 2008
September 6, 2016
October 27, 2016
October 27, 2016
March 2008
November 2012   (Final data collection date for primary outcome measure)
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.
Conversion to Psychosis [ Time Frame: 6 months ]
Complete list of historical versions of study NCT00635700 on ClinicalTrials.gov Archive Site
Improvement SOPS Total Score [ Time Frame: 8 weeks ]
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Sexes Eligible for Study: All
16 Years to 40 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00635700
0801003386
IIR GA1281GE
Yes
Not Provided
Not Provided
Yale University
Yale University
Not Provided
Principal Investigator: Scott W Woods, MD Yale University
Yale University
September 2016

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