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

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ClinicalTrials.gov Identifier: NCT00423878
Recruitment Status : Completed
First Posted : January 18, 2007
Results First Posted : December 19, 2012
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
National Institute of Mental Health (NIMH)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Schizophrenia
Schizoaffective Disorder
Interventions Drug: Risperidone
Drug: Olanzapine
Drug: Quetiapine
Drug: Aripiprazole
Enrollment 215

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Switch Group Stay Group
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 109 106
Completed 89 98
Not Completed 20 8
Arm/Group Title Switch Group Stay Group Total
Hide Arm/Group Description Participants will switch to aripiprazole. Participants will continue treatment with olanzapine, quetiapine, or risperidone. Total of all reporting groups
Overall Number of Baseline Participants 109 106 215
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants 106 participants 215 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
109
 100.0%
106
 100.0%
215
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 109 participants 106 participants 215 participants
40  (11.7) 42  (10.5) 41  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants 106 participants 215 participants
Female
41
  37.6%
37
  34.9%
78
  36.3%
Male
68
  62.4%
69
  65.1%
137
  63.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 109 participants 106 participants 215 participants
109 106 215
non-HDL cholesterol  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 109 participants 106 participants 215 participants
169  (31.9) 176  (33.5) 173  (32.8)
1.Primary Outcome
Title Change in Non-HDL Cholesterol Level for Patients Assigned to Stay and Patients Assigned to Switch Over 24 Weeks
Hide Description Change in non-HDL cholesterol measured at baseline and every 4 weeks for 24 weeks. The efficacy analysis corresponded to a comparison of change in non-HDL cholesterol from baseline to 24 weeks between treatment groups (stay versus switch). Repeated measurements mixed effects linear models were fit for the primary analysis.
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The primary efficacy analysis was conducted on the efficacy evaluable population, defined as all patients randomly assigned to a study group who received at least one dose of study medication and completed at least one post-baseline efficacy assessment.
Arm/Group Title Switch Group Stay Group
Hide Arm/Group Description:
Participants will switch to aripiprazole.
Participants will continue treatment with olanzapine, quetiapine, or risperidone.
Overall Number of Participants Analyzed 89 98
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL non-HDL cholesterol
-20.2  (2.87) -10.8  (2.57)
2.Secondary Outcome
Title 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)
Hide Description [Not Specified]
Time Frame Measured at Month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
2 participants who never took assigned study medication were excluded.
Arm/Group Title Switch Group Stay Group
Hide Arm/Group Description:
Participants will switch to aripiprazole.
Participants will continue treatment with olanzapine, quetiapine, or risperidone.
Overall Number of Participants Analyzed 107 106
Measure Type: Number
Unit of Measure: participants
22 18
Time Frame [Not Specified]
Adverse Event Reporting Description Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.
 
Arm/Group Title Switch Group Stay Group
Hide Arm/Group Description Participants will switch to aripiprazole. Participants will continue treatment with olanzapine, quetiapine, or risperidone.
All-Cause Mortality
Switch Group Stay Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Switch Group Stay Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/107 (16.82%)      9/106 (8.49%)    
Blood and lymphatic system disorders     
Agranulocytosis *  1/107 (0.93%)  1 0/106 (0.00%)  0
Cardiac disorders     
Syncope *  0/107 (0.00%)  0 1/106 (0.94%)  1
Gastrointestinal disorders     
Gastroenteritis *  1/107 (0.93%)  1 0/106 (0.00%)  0
General disorders     
Slurred speech/sedation *  1/107 (0.93%)  2 0/106 (0.00%)  0
Accidental overdose *  1/107 (0.93%)  1 1/106 (0.94%)  1
Victim of gunshot wound *  1/107 (0.93%)  1 0/106 (0.00%)  0
 *  1/107 (0.93%)  1 1/106 (0.94%)  1
Nervous system disorders     
Neuropathic pain *  1/107 (0.93%)  1 0/106 (0.00%)  0
Psychiatric disorders     
Exacerbation of schizophrenia *  9/107 (8.41%)  11 3/106 (2.83%)  4
Suicidality *  0/107 (0.00%)  0 2/106 (1.89%)  2
Agitation *  1/107 (0.93%)  2 0/106 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pneumonia *  1/107 (0.93%)  1 1/106 (0.94%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Switch Group Stay Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   77/107 (71.96%)      77/106 (72.64%)    
Endocrine disorders     
Problems with sex drive   24/107 (22.43%)  24 26/106 (24.53%)  26
Problems with sexual orgasm   20/107 (18.69%)  20 19/106 (17.92%)  19
Problems with sexual arousal   20/107 (18.69%)  20 18/106 (16.98%)  18
Menstrual irregularities   10/107 (9.35%)  10 6/106 (5.66%)  6
Gynecomastia/galactorrhea   2/107 (1.87%)  2 4/106 (3.77%)  4
Gastrointestinal disorders     
Dry mouth   24/107 (22.43%)  24 36/106 (33.96%)  36
Constipation   20/107 (18.69%)  20 20/106 (18.87%)  20
Nausea   12/107 (11.21%)  12 18/106 (16.98%)  18
General disorders     
Increased appetite   18/107 (16.82%)  18 26/106 (24.53%)  26
Weight gain   20/107 (18.69%)  20 21/106 (19.81%)  21
Hypersomnia   16/107 (14.95%)  16 21/106 (19.81%)  21
Orthostatic faintness   19/107 (17.76%)  19 18/106 (16.98%)  18
Sialorrhea   8/107 (7.48%)  8 7/106 (6.60%)  7
Nervous system disorders     
Akathisia/activation   29/107 (27.10%)  29 26/106 (24.53%)  26
Akinesia   14/107 (13.08%)  14 25/106 (23.58%)  25
Psychiatric disorders     
Insomnia   44/107 (41.12%)  44 29/106 (27.36%)  29
Sleepiness   27/107 (25.23%)  27 35/106 (33.02%)  35
Renal and urinary disorders     
Incontinence/nocturia   9/107 (8.41%)  9 13/106 (12.26%)  13
Urinary hesistancy   5/107 (4.67%)  5 4/106 (3.77%)  4
Skin and subcutaneous tissue disorders     
Skin rash   8/107 (7.48%)  8 12/106 (11.32%)  12
Indicates events were collected by systematic assessment
Open-label treatment is a limitation of this study, particularly for outcomes not measured in the laboratory but instead subject to clinical judgment.
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: Dr. Scott Stroup
Organization: Columbia University
Phone: 212-543-5676
Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00423878     History of Changes
Other Study ID Numbers: STROUP06STN0
DSIR AT-AP ( Other Identifier: National Institute of Mental Health )
First Submitted: January 16, 2007
First Posted: January 18, 2007
Results First Submitted: November 16, 2012
Results First Posted: December 19, 2012
Last Update Posted: November 2, 2016