Seroquel in Acute Mania: Study to Investigate if Valproate Add-On Therapy is Superior to Quetiapine Monotherapy in Acutely Manic Patients
Phase 4
Terminated
- Conditions
- Bipolar Disorder
- Interventions
- Registration Number
- NCT00139074
- Lead Sponsor
- AstraZeneca
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 17
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Quetiapine fumarate quetiapine fumarate monotherapy 2 Quetiapine fumarate Quetiapine + sodium valproate 2 sodium valproate Quetiapine + sodium valproate
- Primary Outcome Measures
Name Time Method The number of responders in the two treatment groups (quetiapine + sodium valproate placebo/quetiapine + sodium valproate) after 2 weeks treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Research Site
🇩🇰Kolding, Denmark
Researcg Site
🇩🇰Svendborg, Denmark