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

Phase 4TerminatedNCT00139074

AstraZeneca17 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Bipolar Disorder

Interventions

Quetiapine fumarateDRUG

oral variable dose

sodium valproateDRUG

oral

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (7)

Research Site

Copenhagen, Denmark

Research Site

Esbjerg, Denmark

Research Site

Frederikssund, Denmark

Research Site

Haderslev, Denmark

Outcomes

Primary Outcomes

The number of responders in the two treatment groups (quetiapine + sodium valproate placebo/quetiapine + sodium valproate)

Time frame: after 2 weeks treatment

Data from ClinicalTrials.gov

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