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Neurocognitive Effects of Ziprasidone: Relationship to Working Memory and Dopamine Blockade

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anil K. Malhotra, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00225498
First received: September 21, 2005
Last updated: September 2, 2015
Last verified: September 2015
Results First Received: December 12, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Schizophrenia
Intervention: Drug: ziprasidone vs risperidone or olanzapine

  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
10 schizophrenia patients who met nonresponse criteria

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The only meaningful analyses with adequate statistical power that could be reported were of the 10 schizophrenia patients who met nonresponse criteria to ziprasidone. The overall enrollment of 35 subjects was insufficient to perform the originally planned analyses in a statistically valid manner.

Reporting Groups
  Description
Ziprasidone ziprasidone target dose is 160 mg/day

Participant Flow:   Overall Study
    Ziprasidone
STARTED   10 
COMPLETED   10 [1] 
NOT COMPLETED   0 
[1] The only analyses with adequate statistical power were of the 10 ziprasidone nonresponders.



  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.
Baseline characteristics for all participants prior to randomization are reported because treatment assignment information is not available. That information was not preserved when the orginally planned analyses were not conducted because the enrollment was insufficient for statistically valid results.

Reporting Groups
  Description
All Participants Baseline characteristics for all participants prior to randomization are reported because treatment assignment information is not available. That information was not preserved when the orginally planned analyses were not conducted because the enrollment was insufficient for statistically valid results.

Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
 35 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   35 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 34.2834  (8.83101) 
Gender 
[Units: Participants]
 
Female   11 
Male   24 
Region of Enrollment 
[Units: Participants]
 
United States   35 


  Outcome Measures

1.  Primary:   Working Memory   [ Time Frame: 3 months ]


  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
This is a small sample.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Anil K. Malhotra, MD
Organization: Feinstein Institute for Medical Research, Zucker Hillside Hospital
phone: 718-470-8012
e-mail: malhotra@lij.edu


Publications:

Responsible Party: Anil K. Malhotra, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT00225498     History of Changes
Other Study ID Numbers: 01-04-200
Study First Received: September 21, 2005
Results First Received: December 12, 2012
Last Updated: September 2, 2015
Health Authority: United States: Institutional Review Board