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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00119652 |
The purpose of this study is to determine whether quetiapine is effective and safe in the acute treatment of bipolar depression and whether the effect is maintained when treatment is continued.
Condition | Intervention | Phase |
---|---|---|
Bipolar Disorder Bipolar Depression Depression |
Drug: quetiapine fumarate (Seroquel) Drug: paroxetine Behavioral: mood stabilizing activity |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Multicentre, Double-Blind, Randomised, Parallel Group, Placebo Controlled, Phase 3 Study of the Efficacy & Safety of Quetiapine Fumarate & Paroxetine as Monotherapy in Adult Patients With Bipolar Depression for 8 Weeks & Quetiapine in Continuation (Abbreviated) |
Enrollment: | 676 |
Study Start Date: | May 2005 |
Study Completion Date: | July 2007 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | AstraZeneca Seroquel Medical Science Director, MD | AstraZeneca |
Study ID Numbers: | D1447C00134 |
Study First Received: | July 6, 2005 |
Last Updated: | November 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00119652 |
Health Authority: | United States: Food and Drug Administration |
Bipolar disorder bipolar depression depression |
Quetiapine Affective Disorders, Psychotic Depression Mental Disorders Bipolar Disorder Mood Disorders |
Psychotic Disorders Depressive Disorder Paroxetine Serotonin Behavioral Symptoms |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents |
Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Agents Therapeutic Uses Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |