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

Study identifier:D1449L00010

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

Phase IV Study to Investigate if Valproate Add-on Therapy is Superior to Quetiapine Monotherapy in Acutely Manic Patients

Medical condition

Bipolar Disorder

Phase

Phase 4

Healthy volunteers

Study drug

Quetiapine fumarate, sodium valproate

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Jul 2005

Primary Completion Date: 01 Jun 2006

Study Completion Date: 01 Jun 2006

Study design

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2013 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

No locations available

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

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Denmark Study Information

+45 43 66 64 62

Investigators

Principal Investigator

Dr. Rasmus Wenzer Licht

AstraZeneca