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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00139074 |
The primary purpose is to investigate whether the addition of sodium valproate will be superior to treatment with quetiapine (Seroquel) given as monotherapy for an additional 14 days in non-responding patients after a 14 day initial treatment period with quetiapine.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Condition | Intervention | Phase |
---|---|---|
Bipolar Disorder |
Drug: Quetiapine fumarate Drug: sodium valproate |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Phase IV Study to Investigate if Valproate Add-on Therapy is Superior to Quetiapine Monotherapy in Acutely Manic Patients |
Estimated Enrollment: | 300 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | August 2010 |
Arms | Assigned Interventions |
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1: Active Comparator
quetiapine fumarate monotherapy
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Drug: Quetiapine fumarate
oral variable dose
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2: Experimental
Quetiapine + sodium valproate
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Drug: Quetiapine fumarate
oral variable dose
Drug: sodium valproate
oral
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Denmark | |
Research Site | |
Esbjerg, Denmark | |
Research Site | |
Frederikssund, Denmark | |
Research Site | |
Haderslev, Denmark | |
Researcg Site | |
Svendborg, Denmark | |
Research Site | |
Kolding, Denmark | |
Research Site | |
Kobenhavn, Denmark | |
Research Site | |
Hellerup, Denmark |
Principal Investigator: | Dr. Rasmus Wenzer Licht | AstraZeneca |
Study Director: | AstraZeneca Seroquel Medical Science Director, MD | AstraZeneca |
Study ID Numbers: | D1449L00010 |
Study First Received: | August 29, 2005 |
Last Updated: | December 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00139074 |
Health Authority: | Denmark: Danish Medicines Agency |
Bipolar I Disorder (DSM-IV 296.01, DSM-IV 296.4, DSM-IV 296.61) |
Quetiapine Affective Disorders, Psychotic Mental Disorders Bipolar Disorder |
Mood Disorders Psychotic Disorders Valproic Acid |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Enzyme Inhibitors |
Antipsychotic Agents Antimanic Agents Pharmacologic Actions Therapeutic Uses GABA Agents Central Nervous System Agents Anticonvulsants |