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

This study has been terminated.

( terminated due to very low recruitment rate (27 June 2006) )

First Received on August 29, 2005. Last Updated on December 8, 2010 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00139074

Purpose

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.

Condition	Intervention	Phase
Bipolar Disorder	Drug: Quetiapine fumarate Drug: sodium valproate	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Phase IV Study to Investigate if Valproate Add-on Therapy is Superior to Quetiapine Monotherapy in Acutely Manic Patients

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Divalproex sodium Valproic acid Quetiapine Quetiapine fumarate Valproate Sodium

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The number of responders in the two treatment groups (quetiapine + sodium valproate placebo/quetiapine + sodium valproate) [ Time Frame: after 2 weeks treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	July 2005
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 quetiapine fumarate monotherapy	Drug: Quetiapine fumarate oral variable dose Other Name: Seroquel
Experimental: 2 Quetiapine + sodium valproate	Drug: Quetiapine fumarate oral variable dose Other Name: Seroquel Drug: sodium valproate oral

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139074

Locations

Denmark
Research Site
Esbjerg, Denmark
Research Site
Frederikssund, Denmark
Research Site
Haderslev, Denmark
Research Site
Hellerup, Denmark
Research Site
Kobenhavn, Denmark
Research Site
Kolding, Denmark
Researcg Site
Svendborg, Denmark

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Dr. Rasmus Wenzer Licht	AstraZeneca
Study Director:	AstraZeneca Seroquel Medical Science Director, MD	AstraZeneca

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00139074 History of Changes
Other Study ID Numbers:	D1449L00010
Study First Received:	August 29, 2005
Last Updated:	December 8, 2010
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by AstraZeneca:

Bipolar I Disorder (DSM-IV 296.01, DSM-IV 296.4, DSM-IV 296.61)

Additional relevant MeSH terms:

Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Valproic Acid
Quetiapine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Antipsychotic Agents

ClinicalTrials.gov processed this record on February 09, 2012