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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2006-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Bipolar Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

quetiapine fumarate monotherapy

Group Type ACTIVE_COMPARATOR

Quetiapine fumarate

Intervention Type DRUG

oral variable dose

2

Quetiapine + sodium valproate

Group Type EXPERIMENTAL

Quetiapine fumarate

Intervention Type DRUG

oral variable dose

sodium valproate

Intervention Type DRUG

oral

Interventions

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Quetiapine fumarate

oral variable dose

Intervention Type DRUG

sodium valproate

oral

Intervention Type DRUG

Other Intervention Names

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Seroquel

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No