drugset / Trial / NCT00139074

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

NCT00139074

Phase 4 Terminated 17 enrolled AstraZeneca
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2005-07
Primary completion
2006-06
Completion
2006-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Quetiapine Small molecule Oral
Subject Valproate Small molecule Oral

Indications