Comparison of Antipsychotics for Metabolic Problems in the Treatment of People With Schizophrenia or Schizoaffective Disorder - Tabular View

Tracking Information

First Received Date ^ICMJE

January 16, 2007

Last Updated Date

November 13, 2009

Start Date ^ICMJE

January 2007

Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Mean difference in non-HDL cholesterol level changes between patients assigned to stay compared to patients assigned to switch at the last observation.

Change History

Complete list of historical versions of study NCT00423878 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Comparison of Antipsychotics for Metabolic Problems in the Treatment of People With Schizophrenia or Schizoaffective Disorder

Official Title ^ICMJE

Clinical Management of Metabolic Problems in Patients With Schizophrenia

Brief Summary

The study will compare the effectiveness of antipsychotic medications for patients with schizophrenia or schizoaffective disorder for whom a medication change may be indicated because of an increased risk of cardiovascular disease.

Detailed Description

Metabolic abnormalities associated with cardiovascular morbidity and premature mortality are more common in patients with schizophrenia than in matched controls. Although there is some evidence that patients with schizophrenia have intrinsic abnormalities in lipid and carbohydrate metabolism, some antipsychotics (i.e., clozapine, olanzapine, quetiapine, and risperidone) are associated with increased rates of metabolic abnormalities that predispose patients to cardiovascular disease.

This is an investigator-initiated clinical trial that will be conducted at 30 research sites that are a part of the NIMH Schizophrenia Trials Network.

The aims of the study are to (1) determine the relative effects of switching to aripiprazole, versus continued treatment with olanzapine, quetiapine, or risperidone, on metabolic parameters associated with cardiovascular disease, and (2) to determine the effects of switching to aripiprazole versus continued treatment with olanzapine, quetiapine, or risperidone on the clinical stability of schizophrenic illness.

This study design is a multi-site, single-blind (rater) randomized controlled trial of 300 patients with schizophrenia or schizoaffective disorder comparing treatment with the following medications: olanzapine, quetiapine, risperidone, and aripiprazole. The study will enroll patients with schizophrenia or schizoaffective disorder for whom a medication change may be indicated because of an increased risk of cardiovascular disease in spite of adequate control of symptoms on their current antipsychotic medication. Patients who are taking olanzapine, quetiapine, or risperidone and who have a body-mass index (BMI) greater than or equal to 27 and non-HDL cholesterol greater than or equal to 130 mg/dl will be eligible (if non-HDL is between 130-139mg/dL, LDL cholesterol must be greater than 100mg/dL). All treatments will be open label. Raters will be blinded to treatment assignment. Patients will be followed for up to 6 months.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Schizophrenia
Schizoaffective Disorder

Intervention ^ICMJE

Drug: Risperidone
Drug: Olanzapine
Drug: Quetiapine
Drug: Aripiprazole
Behavioral: Intervention used to control diet and modify activity level

Study Arms / Comparison Groups

Experimental: Participants will switch to aripiprazole.
Active Comparator: Participants will continue treatment with olanzapine, quetiapine, or risperidone.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

300

Estimated Completion Date

May 2010

Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosed with schizophrenia or schizoaffective disorder
Currently treated with olanzapine, quetiapine or risperidone
BMI greater than or equal to 27
Non-HDL cholesterol greater than or equal to 130 mg/dL (if non-HDL cholesterol is between 130 - 139 mg/dL, then LDL cholesterol must be greater than 100 mg/dL).

Exclusion Criteria:

Diabetes (FBS greater than or equal to 126) or treatment with oral hypoglycemic drug or insulin
Non-HDL cholesterol greater than 300 mg/dL
Serum triglycerides greater than 500 mg/dL
Patients in the first episode of schizophrenia or schizoaffective disorder
Known hypersensitivity to aripiprazole
On weight loss medications

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00423878

Responsible Party

T. Scott Stroup, MD, MPH, University of North Carolina, Chapel Hill

Study ID Numbers ^ICMJE

STROUP06STN0, DSIR AT-AP

Study Sponsor ^ICMJE

National Institute of Mental Health (NIMH)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	T. Scott Stroup, MD, MPH	The University of North Carolina at Chapel Hill
Study Director:	Joseph P. McEvoy, MD	Duke University

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP