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: November 16, 2012
Last verified: November 2010
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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
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. |
| Stay Group | Participants will continue treatment with olanzapine, quetiapine, or risperidone. |
Participant Flow: Overall Study
| Switch Group | Stay Group | |
|---|---|---|
| STARTED | 109 | 106 |
| COMPLETED | 89 | 98 |
| NOT COMPLETED | 20 | 8 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Switch Group | Participants will switch to aripiprazole. |
| Stay Group | Participants will continue treatment with olanzapine, quetiapine, or risperidone. |
| Total | Total of all reporting groups |
Baseline Measures
| Switch Group | Stay Group | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
109 | 106 | 215 |
|
Age
[units: participants] |
|||
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 109 | 106 | 215 |
| >=65 years | 0 | 0 | 0 |
|
Age
[units: years] Mean ± Standard Deviation |
40 ± 11.7 | 42 ± 10.5 | 41 ± 11.1 |
|
Gender
[units: participants] |
|||
| Female | 41 | 37 | 78 |
| Male | 68 | 69 | 137 |
|
Region of Enrollment
[units: participants] |
|||
| United States | 109 | 106 | 215 |
|
non-HDL cholesterol
[units: mg/dL] Mean ± Standard Deviation |
169 ± 31.9 | 176 ± 33.5 | 173 ± 32.8 |
Outcome Measures
| 1. Primary: | Mean Difference in Non-HDL Cholesterol Level Changes Between Patients Assigned to Stay Compared to Patients Assigned to Switch at the Last Observation [ Time Frame: Measured at Month 6 ] |
| 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
| Time Frame | No text entered. |
|---|---|
| Additional Description | No text entered. |
Frequency Threshold
| Threshold above which other adverse events are reported | 2% |
|---|
Reporting Groups
| Description | |
|---|---|
| Switch Group | Participants will switch to aripiprazole. |
| Stay Group | Participants will continue treatment with olanzapine, quetiapine, or risperidone. |
Other Adverse Events
| Switch Group | Stay Group | |
|---|---|---|
| Total, other (not including serious) adverse events | ||
| # participants affected / at risk | 77/107 | 77/106 |
| Endocrine disorders | ||
| Problems with sex drive † | ||
| # participants affected / at risk | 24/107 (22.43%) | 26/106 (24.53%) |
| # events | 24 | 26 |
| Problems with sexual orgasm † | ||
| # participants affected / at risk | 20/107 (18.69%) | 19/106 (17.92%) |
| # events | 20 | 19 |
| Problems with sexual arousal † | ||
| # participants affected / at risk | 20/107 (18.69%) | 18/106 (16.98%) |
| # events | 20 | 18 |
| Menstrual irregularities † | ||
| # participants affected / at risk | 10/107 (9.35%) | 6/106 (5.66%) |
| # events | 10 | 6 |
| Gynecomastia/galactorrhea † | ||
| # participants affected / at risk | 2/107 (1.87%) | 4/106 (3.77%) |
| # events | 2 | 4 |
| Gastrointestinal disorders | ||
| Dry mouth † | ||
| # participants affected / at risk | 24/107 (22.43%) | 36/106 (33.96%) |
| # events | 24 | 36 |
| Constipation † | ||
| # participants affected / at risk | 20/107 (18.69%) | 20/106 (18.87%) |
| # events | 20 | 20 |
| Nausea † | ||
| # participants affected / at risk | 12/107 (11.21%) | 18/106 (16.98%) |
| # events | 12 | 18 |
| General disorders | ||
| Increased appetite † | ||
| # participants affected / at risk | 18/107 (16.82%) | 26/106 (24.53%) |
| # events | 18 | 26 |
| Weight gain † | ||
| # participants affected / at risk | 20/107 (18.69%) | 21/106 (19.81%) |
| # events | 20 | 21 |
| Hypersomnia † | ||
| # participants affected / at risk | 16/107 (14.95%) | 21/106 (19.81%) |
| # events | 16 | 21 |
| Orthostatic faintness † | ||
| # participants affected / at risk | 19/107 (17.76%) | 18/106 (16.98%) |
| # events | 19 | 18 |
| Sialorrhea † | ||
| # participants affected / at risk | 8/107 (7.48%) | 7/106 (6.60%) |
| # events | 8 | 7 |
| Nervous system disorders | ||
| Akathisia/activation † | ||
| # participants affected / at risk | 29/107 (27.10%) | 26/106 (24.53%) |
| # events | 29 | 26 |
| Akinesia † | ||
| # participants affected / at risk | 14/107 (13.08%) | 25/106 (23.58%) |
| # events | 14 | 25 |
| Psychiatric disorders | ||
| Insomnia † | ||
| # participants affected / at risk | 44/107 (41.12%) | 29/106 (27.36%) |
| # events | 44 | 29 |
| Sleepiness † | ||
| # participants affected / at risk | 27/107 (25.23%) | 35/106 (33.02%) |
| # events | 27 | 35 |
| Renal and urinary disorders | ||
| Incontinence/nocturia † | ||
| # participants affected / at risk | 9/107 (8.41%) | 13/106 (12.26%) |
| # events | 9 | 13 |
| Urinary hesistancy † | ||
| # participants affected / at risk | 5/107 (4.67%) | 4/106 (3.77%) |
| # events | 5 | 4 |
| Skin and subcutaneous tissue disorders | ||
| Skin rash † | ||
| # participants affected / at risk | 8/107 (7.48%) | 12/106 (11.32%) |
| # events | 8 | 12 |
| † | Events were collected by systematic assessment |
|---|
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| 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. |
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. |
Results Point of Contact:
Name/Title: Dr. Scott Stroup
Organization: Columbia University
phone: 212-543-5676
e-mail: stroups@nyspi.columbia.edu
Organization: Columbia University
phone: 212-543-5676
e-mail: stroups@nyspi.columbia.edu
No publications provided
| Responsible Party: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00423878 History of Changes |
| Other Study ID Numbers: | STROUP06STN0, DSIR AT-AP |
| Study First Received: | January 16, 2007 |
| Results First Received: | November 16, 2012 |
| Last Updated: | November 16, 2012 |
| Health Authority: | United States: Federal Government |