The primary purpose is to investigate whether the addition of sodium valproate will be superior to treatment with quetiapine given as mono-therapy for an additional 14 days in non-responding patients after a 14 days initial treatment period with quetiapine.

Condition	Intervention	Phase
Bipolar I Disorder (DSM-IV 296.01, DSM-IV 296.4, DSM-IV 296.61)	Drug: Quetiapine / Valproate treatment of acute manic disease	Phase IV

Further Study Details: 

Primary Outcomes: The number of responders in the two treatment groups (quetiapine + sodium valproate placebo / quetiapine + sodium valproate) after 2 weeks treatment.
Secondary Outcomes: The number of responders to the initial 14 days quetiapine treatment
Expected Total Enrollment:  300

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  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 anti manic response to sodium valproate or quetiapine fumarate, involuntary admittance / detainment.

Please refer to this study by ClinicalTrials.gov identifier  NCT00139074

Denmark
      Esbjerg N,  Denmark; Recruiting
      Frederiksberg,  Denmark; Recruiting
      Frederikssund,  Denmark; Recruiting
      Glostrup,  Denmark; Recruiting
      Haderslev,  Denmark; Recruiting
      Hellerup,  Denmark; Recruiting
      Hillerod,  Denmark; Recruiting
      Kolding,  Denmark; Recruiting
      Kobenhavn K,  Denmark; Recruiting
      Ribe,  Denmark; Recruiting
      Risskov,  Denmark; Recruiting
      Svendborg,  Denmark; Recruiting

Study chairs or principal investigators

Dr. Rasmus Wenzer Licht,  Principal Investigator,  Not available   

Study ID Numbers:  D1449L00010
Last Updated:  August 30, 2005
Record first received:  August 29, 2005
ClinicalTrials.gov Identifier:  NCT00139074
Health Authority: Denmark: Danish Medicines Agency
ClinicalTrials.gov processed this record on 2005-09-06