Seroquel in Acute Mania: Study to Investigate if Valproate Add-On Therapy is Superior to Quetiapine Monotherapy in Acutely Manic Patients
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder
Intervention: Quetiapine fumarate (Drug); sodium valproate (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Dr. Rasmus Wenzer Licht, Principal Investigator, Affiliation: AstraZeneca
AstraZeneca Seroquel Medical Science Director, MD, Study Director, Affiliation: AstraZeneca
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.
Clinical Details
Official title: Phase IV Study to Investigate if Valproate Add-on Therapy is Superior to Quetiapine Monotherapy in Acutely Manic Patients
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: The number of responders in the two treatment groups (quetiapine + sodium valproate placebo/quetiapine + sodium valproate)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Research Site, Esbjerg, Denmark
Research Site, Frederikssund, Denmark
Research Site, Haderslev, Denmark
Research Site, Hellerup, Denmark
Research Site, Kolding, Denmark
Research Site, Kobenhavn, Denmark
Researcg Site, Svendborg, Denmark
Additional Information
Starting date: July 2005
Ending date: August 2010
Last updated: December 14, 2007
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