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NCT00547118 · ClinicalTrials.gov registry record · Phase 2
The Effects of Rimonabant, on Weight and Metabolic Risk Factors
A Phase 2 study, sponsored by University of Maryland, Baltimore.
- Terminated
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT00547118 is a Phase 2 study that was terminated before completion, run by University of Maryland, Baltimore. The registered enrollment target is 17 participants.
The verdict
NCT00547118, a Phase 2 study, was terminated before completion, sponsored by University of Maryland, Baltimore.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study 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
Interventions
- DRUG Placebo
- DRUG Rimonabant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2007-11 |
| Est. Completion | 2009-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00547118
The ClinicalTrials.gov registry entry for NCT00547118 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00547118 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00547118 about?
NCT00547118 is a clinical study titled "The Effects of Rimonabant, on Weight and Metabolic Risk Factors". 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 metabol...
What is the current status of trial NCT00547118?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2007-11. Estimated completion is 2009-03.
What interventions are being tested in trial NCT00547118?
The interventions under investigation include: Placebo (DRUG), Rimonabant (DRUG).
Who is sponsoring clinical trial NCT00547118?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
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