Ziprasidone in the Psychosis Prodrome (ZIP)

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. Identifier: NCT00635700
Recruitment Status : Completed
First Posted : March 14, 2008
Results First Posted : October 27, 2016
Last Update Posted : October 27, 2016
Information provided by (Responsible Party):
Yale University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Psychosis Prodrome
Interventions: Drug: ziprasidone
Drug: placebo

  Participant Flow

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
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

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
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 
[Units: Years]
Mean (Standard Deviation)
 21.9  (4.7)   22.6  (3.7)   22.3  (4.2) 
[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.  

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

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
No text entered.

  More Information

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

Responsible Party: Yale University Identifier: NCT00635700     History of Changes
Other Study ID Numbers: 0801003386
First Submitted: March 6, 2008
First Posted: March 14, 2008
Results First Submitted: September 6, 2016
Results First Posted: October 27, 2016
Last Update Posted: October 27, 2016