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

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00139074
• Other study ID #: D1449L00010
• Status: Terminated
• Phase: Phase 4
• First received: August 29, 2005
• Last updated: January 25, 2013
• Start date: July 2005
• Est. completion date: June 2006

Study information

• Verified date: January 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Quetiapine fumarate
oral variable dose
• sodium valproate
oral

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of responders in the two treatment groups (quetiapine + sodium valproate placebo/quetiapine + sodium valproate)		after 2 weeks treatment	No