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Sponsored by: |
University of Cincinnati |
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Information provided by: | University of Cincinnati |
ClinicalTrials.gov Identifier: | NCT00394095 |
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 |
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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 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: olanzapine/topiramate
olanzapine - 5 mg/day to 20 mg/day, oral topiramate - 25 mg/day to 100 mg/day, oral
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2: Placebo Comparator |
Drug: olanzapine/placebo
olanzapine - 5 mg/day to 20 mg/day, oral placebo - oral
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Ages Eligible for Study: | 10 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Allison Albertz, BSN, RN | 513-558-4812 | allison.albertz@psychiatry.uc.edu |
United States, Ohio | |
University of Cincinnati Medical Center | Recruiting |
Cincinnati, Ohio, United States, 45267-0559 | |
Contact: Jenny Daniels, MA 513-558-0956 jennifer.daniels@psychiatry.uc.edu | |
Principal Investigator: Melissa P DelBello, MD |
Principal Investigator: | Melissa P DelBello, MD | University of Cincinnati |
Responsible Party: | University of Cincinnati ( Melissa P. DelBello, MD ) |
Study ID Numbers: | F1D-MC-X304 |
Study First Received: | October 27, 2006 |
Last Updated: | July 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00394095 |
Health Authority: | United States: Food and Drug Administration |
Body Weight Signs and Symptoms Affective Disorders, Psychotic Mental Disorders Bipolar Disorder Olanzapine |
Body Weight Changes Mood Disorders Topiramate Psychotic Disorders Weight Gain Serotonin |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Disease Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Gastrointestinal Agents Psychotropic Drugs Antiemetics Central Nervous System Depressants Antipsychotic Agents Serotonin Uptake Inhibitors |
Neuroprotective Agents Protective Agents Pharmacologic Actions Anti-Obesity Agents Serotonin Agents Pathologic Processes Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |