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

AstraZeneca

Status and phase: Terminated; Phase 4

Conditions: Bipolar Disorder

Treatments: Drug: Quetiapine fumarate; Drug: sodium valproate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00139074

D1449L00010

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

17 participants in 2 patient groups

1

Active Comparator group

Description:

quetiapine fumarate monotherapy

Treatment:

Drug: Quetiapine fumarate

2

Experimental group

Description:

Quetiapine + sodium valproate

Treatment:

Drug: Quetiapine fumarate

Drug: sodium valproate