Status:

TERMINATED

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

Lead Sponsor:

AstraZeneca

Conditions:

Bipolar Disorder

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief 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...

Eligibility Criteria

Inclusion

  • Patients suffering from a manic or mixed episode.

Exclusion

  • 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.

Key Trial Info

Start Date :

July 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2006

Estimated Enrollment :

17 Patients enrolled

Trial Details

Trial ID

NCT00139074

Start Date

July 1 2005

End Date

June 1 2006

Last Update

January 28 2013

Active Locations (7)

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Page 1 of 2 (7 locations)

1

Research Site

Copenhagen, Denmark

2

Research Site

Esbjerg, Denmark

3

Research Site

Frederikssund, Denmark

4

Research Site

Haderslev, Denmark