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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar Disorder

Intervention: Quetiapine fumarate (Drug); sodium valproate (Drug)

Phase: Phase 4

Status: Terminated

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. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

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

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, Kobenhavn, Denmark

Research Site, Kolding, Denmark

Researcg Site, Svendborg, Denmark

Additional Information

Starting date: July 2005
Last updated: January 25, 2013

Page last updated: August 23, 2015

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