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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: September 6, 2016
Last verified: September 2016
Results First Received: September 6, 2016  
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
Condition: Psychosis Prodrome
Interventions: Drug: ziprasidone
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ziprasidone ziprasidone: 20-160 mg/d
Placebo placebo: placebo

Participant Flow:   Overall Study
    Ziprasidone   Placebo
STARTED   24   27 
COMPLETED   9   13 
NOT COMPLETED   15   14 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Of 51 patients randomized, 27 were assigned to placebo and 24 to ziprasidone. One case allocated to ziprasidone was never dispensed study medication and was removed from analysis per protocol, leaving 23.

Reporting Groups
  Description
Ziprasidone ziprasidone: 20-160 mg/d
Placebo placebo: placebo
Total Total of all reporting groups

Baseline Measures
   Ziprasidone   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 23   27   50 
Age 
[Units: Years]
Mean (Standard Deviation)
 21.9  (4.7)   22.6  (3.7)   22.3  (4.2) 
Gender 
[Units: Participants]
     
Female   10   8   18 
Male   13   19   32 
Region of Enrollment 
[Units: Participants]
     
United States   23   27   50 


  Outcome Measures

1.  Primary:   Conversion to Psychosis   [ Time Frame: 6 months ]

2.  Secondary:   Improvement SOPS Total Score   [ Time Frame: 8 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Scott W. Woods, M.D.
Organization: Yale University
phone: 203-974-7038
e-mail: scott.woods@yale.edu



Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00635700     History of Changes
Other Study ID Numbers: 0801003386
IIR GA1281GE
Study First Received: March 6, 2008
Results First Received: September 6, 2016
Last Updated: September 6, 2016
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Canada: Health Canada Clinical Trials Application control number 120085