Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Comparison of Antipsychotics for Metabolic Problems in Schizophrenia or Schizoaffective Disorder (CAMP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00423878
First received: January 16, 2007
Last updated: September 27, 2016
Last verified: November 2010
Results First Received: November 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Schizophrenia
Schizoaffective Disorder
Interventions: Drug: Risperidone
Drug: Olanzapine
Drug: Quetiapine
Drug: Aripiprazole

  Participant Flow
  Hide 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
  Description
Switch Group Participants will switch to aripiprazole with a cross-titration from the current antipsychotic over 3-4 weeks. Allowed final dosage range for aripiprazole was 5-30 mg/day.
Stay Group Participants will continue with their current antipsychotic treatment, either olanzapine 5-20 mg/day, quetiapine 200-1200 mg/day, or risperidone 1-16 mg/day.

Participant Flow:   Overall Study
    Switch Group   Stay Group
STARTED   109   106 
COMPLETED   89   98 
NOT COMPLETED   20   8 



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Non-HDL Cholesterol Level for Patients Assigned to Stay and Patients Assigned to Switch Over 24 Weeks   [ Time Frame: 24 weeks ]

2.  Secondary:   Efficacy Failure, Defined as Psychiatric Hospitalization, a 25 Percent Increase From Baseline on the Positive and Negative Syndrome Scale or Substantial Clinical Deterioration on the Clinical Global Impressions-Change (CGI-C)   [ Time Frame: Measured at Month 6 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
Open-label treatment is a limitation of this study, particularly for outcomes not measured in the laboratory but instead subject to clinical judgment.


  More Information