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Sponsors and Collaborators: |
University of Maryland National Institute on Drug Abuse (NIDA) |
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Information provided by: | University of Maryland |
ClinicalTrials.gov Identifier: | NCT00547118 |
1) To examine the efficacy of rimonabant in decreasing weight and metabolic parameters/cardiovascular disease risk in people with schizophrenia receiving second generation antipsychotics 2) To examine the safety and tolerability of rimonabant as an adjunctive agent for decreasing weight and metabolic risk in people with schizophrenia 3) To examine the efficacy of rimonabant for neurocognitive impairments in people with schizophrenia treated with second-generation antipsychotics (secondary outcome) 4) To examine the efficacy of rimonabant for patient perceived health outcomes and quality of life (secondary outcome) 5) To test the effect of rimonabant on cigarette smoking, nicotine dependence and nicotine craving in people with schizophrenia 6) To examine the effects of rimonabant on food satiety in people with schizophrenia
There is an increasing awareness of the problem of metabolic issues in people with schizophrenia and renewed focus on physical health care for this population. There is under-treatment, in general, of medical conditions in people with schizophrenia, and increased mortality from natural causes. People with schizophrenia are at risk for developing obesity due to many factors including inactive lifestyle, poor dietary choices, and side effects of the commonly used atypical antipsychotics. Metabolic syndrome has been discussed in the cardiology and endocrinology for over two decades, but its prevalence in the mentally ill is only now being fully realized. Diabetes mellitus may be twice as prevalent among patients with schizophrenia as in the general population and metabolic syndrome is probably even more prevalent than diabetes among people with schizophrenia. There is now an opportunity to address this serious problem. A new drug, rimonabant, has recently been approved in several European and Latin American countries. This drug represents the first of a new class of psychoactive drugs witch may improve metabolic problems through decreasing appetite drive. This may also help decrease the drive for cigarette use, which is also a great problem for people with schizophrenia. Is this a safe and effective treatment in this population? This study proposes to test this question in a rapid study, which will develop the basis for future work in this important area.
Condition | Intervention | Phase |
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Schizophrenia Schizoaffective Disorder Obesity Hypertension Smoking |
Drug: Rimonabant Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
Official Title: | The Effects of the Cannabinoid-1 Receptor Antagonist, Rimoanbant, on Weight and Metabolic Risk Factors in People With Schizophrenia |
Estimated Enrollment: | 60 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | January 2012 |
Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Rimonabant
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Drug: Rimonabant
Rimonabant, 1 20 mg tablet given 1 time per day for 112 days.
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2: Placebo Comparator
Placebo
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Drug: Placebo
Placebo
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
16. Subjects must be judged competent to participate in the informed consent process (by passing the ESC with a score of 10/12) and provide voluntary informed consent.
Contact: AnnMarie Kearns, B.S. | 410-402-6854 | akearns@mprc.umaryland.edu |
United States, Maryland | |
Maryland Psychiatric Research Center (MPRC) Outpatient Research Program (ORP); the MPRC Treatment Research Program (TRP) | Recruiting |
Catonsville, Maryland, United States, 21228 | |
Contact: AnnMarie Kearns, BS 410-402-6854 akearns@mprc.umaryland.edu | |
Contact: Jared Linthicum, MA 410-402-6816 jlinthicum@mprc.umaryalnd.edu | |
Baltimore VA Medical Center | Not yet recruiting |
Baltimore, Maryland, United States, 21201 | |
Contact: Ann Kearns 410-402-6854 akearns@mprc.umaryland.edu | |
Principal Investigator: Robert W Buchanan, MD | |
Keypoint Health System | Not yet recruiting |
Baltimore, Maryland, United States, 21201 | |
Contact: Ann Kearns 410-402-6854 akearns@mprc.umaryland.edu | |
Principal Investigator: Robert W Buchanan, MD | |
Sheppard Pratt Health System | Not yet recruiting |
Baltimore, Maryland, United States, 21201 | |
Contact: Ann Kearns 410-402-6854 akearns@mprc.umaryalnd.edu | |
Principal Investigator: Robert W Buchanan, MD |
Principal Investigator: | Robert W Buchanan, MD | Maryland Psychiatric Research Center |
Responsible Party: | University of Maryland Baltimore, Maryland Psychiatric Research Center ( Robert W. Buchanan, M.D. ) |
Study ID Numbers: | H-29033 |
Study First Received: | October 19, 2007 |
Last Updated: | September 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00547118 |
Health Authority: | United States: Food and Drug Administration |
Metabolic abnormalities Safety Satiety |
Obesity Vascular Diseases Overweight Body Weight Schizophrenia Smoking Signs and Symptoms |
Mental Disorders Nutrition Disorders Psychotic Disorders Overnutrition Congenital Abnormalities Schizophrenia and Disorders with Psychotic Features Hypertension |
Cardiovascular Diseases |