Effectiveness of Aripiprazole for Improving Side Effects of Clozapine in the Treatment of People With Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David C. Henderson, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00345033
First received: June 23, 2006
Last updated: August 14, 2012
Last verified: August 2012
Results First Received: April 26, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Schizophrenia
Insulin Resistance
Interventions: Drug: Aripiprazole
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
Subjects were recruited from the Freedom Trail Clinic at the Erich Lindemann Mental Health Center and were studied at the General Clinical Research Center (GCRC) at the Massachusetts General Hospital (MGH), Boston and the Freedom Trail Clinic.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After providing written informed consent, subjects underwent a diagnostic evaluation by a research psychiatrist using the Structured Clinical Interview for DSM-IV (SCID). All subjects were screened and enrolled based on eligibility criteria. Baseline study assessments were completed prior to intervention.

Reporting Groups
  Description
Aripiprazole Participants will take aripiprazole for 8 weeks.
Placebo Participants will take placebo for 8 weeks.

Participant Flow:   Overall Study
    Aripiprazole     Placebo  
STARTED     20     18  
COMPLETED     16     14  
NOT COMPLETED     4     4  



  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.
No text entered.

Reporting Groups
  Description
Aripiprazole Participants will take aripiprazole for 8 weeks.
Placebo Participants will take placebo for 8 weeks.
Total Total of all reporting groups

Baseline Measures
    Aripiprazole     Placebo     Total  
Number of Participants  
[units: participants]
  20     18     38  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     20     18     38  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  44.3  ± 8.2     44.2  ± 8.9     44.25  ± 8.6  
Gender  
[units: participants]
     
Female     4     8     12  
Male     16     10     26  
Region of Enrollment  
[units: participants]
     
United States     20     18     38  



  Outcome Measures
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1.  Primary:   Change in Total Cholesterol   [ Time Frame: Measured at Baseline and Week 8 ]

2.  Primary:   Change in Weight   [ Time Frame: Measured at Baseline and Week 8 ]

3.  Primary:   Change in Body Mass Index (BMI)   [ Time Frame: Measured at Baseline and Week 8 ]

4.  Primary:   Change in Glucose Metabolism   [ Time Frame: Measured at Baseline and Week 8 ]

5.  Primary:   Change in Triglycerides   [ Time Frame: Measured at Baseline and Week 8 ]

6.  Primary:   Change in Insulin Resistance   [ Time Frame: Measured at Baseline and Week 8 ]


  Serious Adverse Events


  Other Adverse Events


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


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
The limitations of this study include the relatively small sample size, short intervention period (8 weeks) and the lack of generalizability of our findings to patients with schizophrenia treated by antipsychotic agents other than clozapine.  


Results Point of Contact:  
Name/Title: David C. Henderson
Organization: Massachusetts General Hospital
phone: (617) 912-7800
e-mail: dchenderson@partners.org


Publications:


Responsible Party: David C. Henderson, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00345033     History of Changes
Other Study ID Numbers: R01 MH072635, R01MH072635, DSIR 83-ATAP
Study First Received: June 23, 2006
Results First Received: April 26, 2012
Last Updated: August 14, 2012
Health Authority: United States: Federal Government