The Effects of Rimonabant, on Weight and Metabolic Risk Factors

This study has been terminated.
(Withdrawn due to medication withdrawal from the EMEA)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
MPRC, University of Maryland
ClinicalTrials.gov Identifier:
NCT00547118
First received: October 19, 2007
Last updated: October 11, 2012
Last verified: October 2012
  Purpose

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
Schizophrenia
Schizoaffective Disorder
Obesity
Hypertension
Smoking
Drug: Rimonabant
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of the Cannabinoid-1 Receptor Antagonist, Rimonabant, on Weight and Metabolic Risk Factors in People With Schizophrenia

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • To examine the efficacy of rimonabant in decreasing weight and metabolic parameters/cardiovascular disease risk in people with schizophrenia receiving second generation antipsychotics [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • To examine the safety and tolerability of rimonabant as an adjunctive agent for decreasing weight and metabolic risk in people with schizophrenia [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • To test the effect of rimonabant on cigarette smoking, nicotine dependence and nicotine craving in people with schizophrenia [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • To examine the effects of rimonabant on food satiety in people with schizophrenia [ Time Frame: End of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To examine the efficacy of rimonabant for neurocognitive impairments in people with schizophrenia treated with second-generation antipsychotics (secondary outcome) [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • To examine the efficacy of rimonabant for patient perceived health outcomes and quality of life (secondary outcome) [ Time Frame: End of study ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: November 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Rimonabant
Drug: Rimonabant
Rimonabant, 1 20 mg tablet given 1 time per day for 112 days.
Placebo Comparator: 2
Placebo
Drug: Placebo
Placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Any gender
  2. Any race,
  3. Age range of 18-55.
  4. Meet DSM-IV (APA, 1994) criteria for either schizophrenia or schizoaffective disorder.
  5. Have a BMI greater than or equal to 27 with treated or untreated hyperlipidemia/ hypertriglyceridemia or a BMI greater than or equal to 30 regardless of concurrent risk factors
  6. Be treated with the same SGA for at least 8 weeks and to have received a constant therapeutic dose for at least 30 days
  7. Be clinically stable (for inpatients: at least one month post admission). Hyperlipidemia and hypertriglyceridemia are defined by ATP III guidelines such that borderline high and high will be considered as criteria for these disorders (ATP III 2001).

Exclusion Criteria:

  1. Subjects with significant recent depressive symptoms will be excluded from the study, defined as any history of a suicide attempt or suicidal ideation or hospitalization for depressive symptoms within the last 6 months; or a high level of current depressive symptoms (Calgary Depression Scale of > 7) (Addington 1993, Kim et al 2006).
  2. Subjects with intermittent alcohol or substance use will not be excluded unless they have met DSM-IV criteria for current alcohol or substance dependence within the last 6 months or DSM-IV criteria for alcohol or substance abuse within the last month.
  3. Subjects with nicotine use or dependence will not be excluded.
  4. Subjects with daily marijuana use will be excluded because of the possibility of physical dependence on cannabis. Those with with marijuana use no more than once a week will not be excluded because such subjects will not be physically dependent on marijuana and so not at risk for rimonabant-elicited acute cannabis withdrawal. Experimental studies of human cannabis physical dependence and withdrawal suggest that high-dose, multiple times a day administration is needed to produce physical dependence (Jones et al., 1976; Haney et al., 1999)
  5. Subjects with a history of Crohn's Disease or Irritable Bowel Syndrome
  6. Subjects with a organic brain disorder
  7. A DSM-IV eating disorder
  8. Subjects with mental retardation will be excluded to exclude subjects with cognitive impairment not related to schizophrenia. Mental retardation will be determined by chart review for a mental retardation diagnosis or a history of an IQ <70 and functional disability noted before the age of 18 (DSM-IV criteria for mental retardation).
  9. Subjects with a medical condition, whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol will be excluded.
  10. Subjects with a history of surgical procedures for weight loss .
  11. Subjects who are currently in the process of trying to quit cigarette smoking will be excluded.
  12. Female subjects of childbearing potential must agree to use medically accepted means of contraception. Pregnant and lactating female subjects will be excluded. People with a diagnosis of diabetes will only be included if their diabetes is currently treated and under control and have been on their current medication regimen for at 3 months.
  13. People with a blood pressure reading of 165/95 or greater at baseline will be excluded from the study.
  14. The concomitant use of medications that are known to alter weight or appetite, including anti-obesity drugs; corticosteroids; or nicotine substitutes will not be allowed (see Appendix 2: Medication Exclusion List). 15. Additionally, patients treated with a form of valproate will not be included in the study.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547118

Locations
United States, Maryland
Baltimore VA Medical Center
Baltimore, Maryland, United States, 21201
Keypoint Health System
Baltimore, Maryland, United States, 21201
Sheppard Pratt Health System
Baltimore, Maryland, United States, 21201
Maryland Psychiatric Research Center (MPRC) Outpatient Research Program (ORP); the MPRC Treatment Research Program (TRP)
Catonsville, Maryland, United States, 21228
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Robert W Buchanan, MD University of Maryland
  More Information

No publications provided

Responsible Party: MPRC, Robert Buchanan, MD, University of Maryland
ClinicalTrials.gov Identifier: NCT00547118     History of Changes
Other Study ID Numbers: HP-00041206
Study First Received: October 19, 2007
Last Updated: October 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Maryland:
Metabolic abnormalities
Safety
Satiety

Additional relevant MeSH terms:
Hypertension
Psychotic Disorders
Schizophrenia
Cardiovascular Diseases
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Vascular Diseases
Rimonabant
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014