Seroquel in Acute Mania: Study to Investigate if Valproate Add-On Therapy is Superior to Quetiapine Monotherapy in Acutely Manic Patients

Verified by: AstraZeneca, September 2009
First Received: August 29, 2005 | Last Updated: December 8, 2010 | Phase: Phase 4 | Start Date: July 2005
Overall Status: Terminated | Estimated Enrollment: 300
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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...

Brief Summary

Official Title: “Phase IV Study to Investigate if Valproate Add-on Therapy is Superior to Quetiapine Monotherapy in Acutely Manic Patients”

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: August 2010

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

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 Investigator Information

Lead Investigator: AstraZeneca Industry

Overall Clinical Trial Officials and Contacts

Dr. Rasmus Wenzer Licht Principal Investigator AstraZeneca  

Additional Information

Information obtained from ClinicalTrials.gov on February 08, 2012

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

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