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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: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
|---|---|
| Experimental: 1 |
Drug: olanzapine/topiramate
olanzapine - 5 mg/day to 20 mg/day, oral topiramate - 25 mg/day to 100 mg/day, oral
|
| Placebo Comparator: 2 |
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: | Melissa P. DelBello, MD, University of Cincinnati |
| ClinicalTrials.gov Identifier: | NCT00394095 History of Changes |
| Other Study ID Numbers: | F1D-MC-X304 |
| Study First Received: | October 27, 2006 |
| Last Updated: | October 9, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Bipolar Disorder Body Weight Weight Gain Affective Disorders, Psychotic Mood Disorders Mental Disorders Signs and Symptoms Body Weight Changes Topiramate Olanzapine Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Neuroprotective Agents |
Protective Agents Physiological Effects of Drugs Anti-Obesity Agents Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents |