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Awarded Trial: 02T-195
Grant ID
02T-195
Illness
Bipolar disorder
Primary Drug/Intervention
Acamprosate
Primary Dosage
1300 to 2000 mg/d
Secondary Drug Intervention
N/A
Secondary Dosage
N/A
Other Drug/Intervention
Concomittant mood stabilizer
Other Dosage
N/A
Status
Completed
Investigator
Grunze
Sample Size
60
Duration of Study Period for Each Subject
10 weeks
Outcome Measurements
Measurements CGI-BP, IDS, YMRS
Results
56 patients were enrolled in the study: 15 patients were treated for an acute manic episode, 20 patients for acute depression, and 21 patients for rapid cycling. Ten patients with mania withdrew prematurely; for the remaining 5 patients there was a significant reduction in YMRS score. There were also many premature discontinuations in the depressed and rapid-cycling groups, for which significant change in clinical ratings could not be demonstrated.
Publication
N/A
Link
N/A
PI Name
Heinz Grunze
Degree
MD
Center
Department of Psychiatry
Institution
LMU Munich
Address
Nussbaumstr. 7
City or Town
N/A
State or Province
Town Munich
Zip or Postal Code
80336
Country
Germany
Email Address
Heinz.Grunze@med.uni-muenchen.de