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

• Status: Terminated
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Quetiapine Fumarate; Valproic Acid

Criteria

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.