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| Sponsor: | Eli Lilly and Company |
|---|---|
| Information provided by: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00485771 |
Purpose
The purpose of this study is to assess olanzapine/fluoxetine combination and lamotrigine comparative efficacy, safety and tolerability in acute and longer term treatment of bipolar depression.
| Condition | Intervention | Phase |
|---|---|---|
|
Bipolar Disorder |
Drug: Olanzapine Drug: Fluoxetine Drug: Lamotrigine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Olanzapine/Fluoxetine Combination Versus Lamotrigine in the Treatment of Bipolar I Depression |
| Enrollment: | 403 |
| Study Start Date: | November 2003 |
| Study Completion Date: | January 2005 |
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Indiana | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Lafayette, Indiana, United States | |
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
More Information
| ClinicalTrials.gov Identifier: | NCT00485771 History of Changes |
| Other Study ID Numbers: | 7980, H6P-US-HDAQ |
| Study First Received: | June 11, 2007 |
| Last Updated: | June 11, 2007 |
| Health Authority: | United States: Food and Drug Administration |
|
Bipolar Disorder Depression Depressive Disorder Affective Disorders, Psychotic Mood Disorders Mental Disorders Behavioral Symptoms Fluoxetine Olanzapine Lamotrigine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Calcium Channel Blockers Membrane Transport Modulators Cardiovascular Agents Anticonvulsants Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Antiemetics |