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

History of Changes

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

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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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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

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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

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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 ]

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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 ]

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Serious Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Reporting Groups

	Description
Switch Group	Participants will switch to aripiprazole.
Stay Group	Participants will continue treatment with olanzapine, quetiapine, or risperidone.

Serious Adverse Events

	Switch Group	Stay Group
Total, serious adverse events
# participants affected / at risk	18/107 (16.82%)	9/106 (8.49%)
Blood and lymphatic system disorders
Agranulocytosis ^*
# participants affected / at risk	1/107 (0.93%)	0/106 (0.00%)
# events	1	0
Cardiac disorders
Syncope ^*
# participants affected / at risk	0/107 (0.00%)	1/106 (0.94%)
# events	0	1
Gastrointestinal disorders
Gastroenteritis ^*
# participants affected / at risk	1/107 (0.93%)	0/106 (0.00%)
# events	1	0
General disorders
Slurred speech/sedation ^*
# participants affected / at risk	1/107 (0.93%)	0/106 (0.00%)
# events	2	0
Accidental overdose ^*
# participants affected / at risk	1/107 (0.93%)	1/106 (0.94%)
# events	1	1
Victim of gunshot wound ^*
# participants affected / at risk	1/107 (0.93%)	0/106 (0.00%)
# events	1	0
Unknown ^*
# participants affected / at risk	1/107 (0.93%)	1/106 (0.94%)
# events	1	1
Nervous system disorders
Neuropathic pain ^*
# participants affected / at risk	1/107 (0.93%)	0/106 (0.00%)
# events	1	0
Psychiatric disorders
Exacerbation of schizophrenia ^*
# participants affected / at risk	9/107 (8.41%)	3/106 (2.83%)
# events	11	4
Suicidality ^*
# participants affected / at risk	0/107 (0.00%)	2/106 (1.89%)
# events	0	2
Agitation ^*
# participants affected / at risk	1/107 (0.93%)	0/106 (0.00%)
# events	2	0
Respiratory, thoracic and mediastinal disorders
Pneumonia ^*
# participants affected / at risk	1/107 (0.93%)	1/106 (0.94%)
# events	1	1

*	Events were collected by non-systematic assessment

Other Adverse Events

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More Information

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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.

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

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

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