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| Sponsored by: |
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: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| 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
| Study ID Numbers: | 7980, H6P-US-HDAQ |
| Study First Received: | June 11, 2007 |
| Last Updated: | June 11, 2007 |
| ClinicalTrials.gov Identifier: | NCT00485771 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Neurotransmitter Agents Olanzapine Psychotropic Drugs Calcium Channel Blockers Antiemetics Affective Disorders, Psychotic Mental Disorders Psychotic Disorders Antidepressive Agents, Second-Generation Antidepressive Agents Depression Tranquilizing Agents Bipolar Disorder |
Central Nervous System Depressants Cardiovascular Agents Depressive Disorder Antipsychotic Agents Serotonin Uptake Inhibitors Serotonin Behavioral Symptoms Fluoxetine Calcium, Dietary Lamotrigine Mood Disorders Peripheral Nervous System Agents Anticonvulsants |
|
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Olanzapine Psychotropic Drugs Antiemetics Calcium Channel Blockers Membrane Transport Modulators Affective Disorders, Psychotic Mental Disorders Therapeutic Uses Antidepressive Agents, Second-Generation Antidepressive Agents Tranquilizing Agents |
Depression Bipolar Disorder Gastrointestinal Agents Central Nervous System Depressants Cardiovascular Agents Antipsychotic Agents Serotonin Uptake Inhibitors Pharmacologic Actions Behavioral Symptoms Fluoxetine Serotonin Agents Autonomic Agents Lamotrigine Mood Disorders Peripheral Nervous System Agents |