The Effects of Rimonabant, on Weight and Metabolic Risk Factors
Status:
Terminated
Trial end date:
2009-03-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
University of Maryland University of Maryland, Baltimore