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...
Date First Received: August 29, 2005
Last Updated: December 19, 2008
Verified by: AstraZeneca, December 2008
Clinical Trial Phase: Phase 4 | Start Date: July 2005
Overall Status: Active, not recruiting
Estimated Enrollment: 300
Brief Summary
Official Title: “Phase IV Study to Investigate if Valproate Add-on Therapy is Superior to Quetiapine Monotherapy in Acutely Manic Patients”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Quetiapine fumarate
- oral variable dose
- Drug: sodium valproate
- oral
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- quetiapine fumarate monotherapy
- Experimental: 2
- Quetiapine + sodium valproate
Outcome Measures for this Clinical Trial
Primary Measures
- The number of responders in the two treatment groups (quetiapine + sodium valproate placebo/quetiapine + sodium valproate)
- Time Frame: after 2 weeks treatment
Safety Issue?: No
- Time Frame: after 2 weeks treatment
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Patients suffering from a manic or mixed episode.
Exclusion Criteria:
- Patients who have not provided personal informed consent,
- Known intolerance, hypersensitivity or lack of antimanic response to sodium valproate or quetiapine fumarate,
- Involuntary admittance/detainment.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: AstraZeneca
Overall Clinical Trial Officials and Contacts
Dr. Rasmus Wenzer Licht Principal Investigator AstraZeneca
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00139074
Study ID Number: D1449L00010
ClinicalTrials.gov Identifier: NCT00139074
Health Authority: Denmark: Danish Medicines Agency
Clinical Trials Authorship and Review
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