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| Sponsor: | University of Cincinnati |
|---|---|
| Information provided by: | University of Cincinnati |
| ClinicalTrials.gov Identifier: | NCT00394095 |
Purpose
The primary objective of this study is to examine the efficacy of topiramate in combination with olanzapine for the prevention of weight gain in youth with bipolar disorder. The secondary objective is to examine the tolerability of topiramate in combination with olanzapine for the prevention of weight gain in youth with bipolar disorder.
| Condition | Intervention | Phase |
|---|---|---|
|
Bipolar Disorder Weight Gain |
Drug: olanzapine/topiramate Drug: olanzapine/placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment |
| Official Title: | A Double-Blind, Randomized, Placebo-Controlled, Pilot Study of Topiramate vs. Placebo in Combination With Olanzapine for the Prevention of Weight Gain in Manic or Mixed Youth With Bipolar Disorder |
| Estimated Enrollment: | 30 |
| Study Start Date: | December 2006 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: olanzapine/topiramate
olanzapine - 5 mg/day to 20 mg/day, oral topiramate - 25 mg/day to 100 mg/day, oral
|
| 2: Placebo Comparator |
Drug: olanzapine/placebo
olanzapine - 5 mg/day to 20 mg/day, oral placebo - oral
|
Eligibility| Ages Eligible for Study: | 10 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Ohio | |
| University of Cincinnati Medical Center | |
| Cincinnati, Ohio, United States, 45267-0559 | |
| Principal Investigator: | Melissa P DelBello, MD | University of Cincinnati |
More Information
| Responsible Party: | University of Cincinnati ( Melissa P. DelBello, MD ) |
| Study ID Numbers: | F1D-MC-X304 |
| Study First Received: | October 27, 2006 |
| Last Updated: | October 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00394095 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Olanzapine Psychotropic Drugs Antiemetics Neuroprotective Agents Body Weight Signs and Symptoms Affective Disorders, Psychotic Pathologic Processes Mental Disorders Therapeutic Uses Body Weight Changes |
Topiramate Disease Tranquilizing Agents Bipolar Disorder Gastrointestinal Agents Central Nervous System Depressants Weight Gain Antipsychotic Agents Protective Agents Serotonin Uptake Inhibitors Pharmacologic Actions Anti-Obesity Agents Serotonin Agents Autonomic Agents Mood Disorders |