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NCT00287352 · ClinicalTrials.gov registry record · Phase 1
Study of Amantadine for Weight Stabilization During Olanzapine Treatment
A Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT00287352 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 40 participants.
The verdict
NCT00287352, a Phase 1 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
Weight gain associated with antipsychotic medication use is a major side effect that limits the tolerability of these drugs. This often significant weight gain adversely affects health, increasing risks for developing cardiovascular disease, diabetes, sleep apnea, cancers of the colon, kidneys, uterus, endometrium and esophagus and osteoarthritis. Beasley and colleagues (1997) reported that 40.5% of olanzapine-treated patients gained more than 7% of baseline weight. Much of the olanzapine induced weight gain occurs early in treatment, and antipsychotic-naïve and young patients (Woods et al., 2002) are particularly vulnerable to this side effect. One of the most promising medications to aid weight loss in patients taking olanzapine is amantadine. Attempts at preventing weight gain are expected to be more successful than attempts to reverse it once it occurs. It is now common clinical practice to educate all patients beginning treatment with olanzapine, and other antipsychotics, about healthy eating and the need for exercise. However, despite this effort, weight gain in this population continues. Beginning a weight-stabilizing medication after a low threshold of weight gain has occurred may have significant impact on patients' health and their willingness to continue to take antipsychotics. We propose to investigate the efficacy of amantadine as a weight-stabilizing agent in a population of first-episode psychotic subjects just beginning treatment with antipsychotic agents. This population is generally young and medically healthy, without contraindications to amantadine. They are often of normal body mass index and without obesity-related medical problems. They have much to gain in preventing the weight gain which so often progresses steadily over the course of treatment, is difficult to reverse and results in significant morbidity and mortality. Additionally, the first episode psychotic population tends to take fewer concomitant psychiatric medications. This is imp
Interventions
- DRUG Olanzapine, Amantadine
- DRUG Olanzapine and placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2005-05 |
| Est. Completion | 2009-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00287352
The ClinicalTrials.gov registry entry for NCT00287352 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Olanzapine, Amantadine is the first listed.
NCT00287352 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00287352 about?
NCT00287352 is a clinical study titled "Study of Amantadine for Weight Stabilization During Olanzapine Treatment". Weight gain associated with antipsychotic medication use is a major side effect that limits the tolerability of these drugs. This often significant weight gain adversely affects health, increasing risks for developing cardiovascular disease, diabetes, sleep apnea, cancers of the colon, kidneys, uter...
What is the current status of trial NCT00287352?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2005-05. Estimated completion is 2009-09.
What interventions are being tested in trial NCT00287352?
The interventions under investigation include: Olanzapine, Amantadine (DRUG), Olanzapine and placebo (DRUG).
Who is sponsoring clinical trial NCT00287352?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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