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Awarded Trial: 07TGF-1148
Grant ID
07TGF-1148
Illness
Bipolar depression
Primary Drug/Intervention
Tianeptine
Primary Dosage
37.5 mg/day
Secondary Drug Intervention
N/A
Secondary Dosage
N/A
Other Drug/Intervention
N/A
Other Dosage
N/A
Status
Completed
Investigator
Kapczinski
Sample Size
160
Duration of Study Period for Each Subject
34-35 weeks
Outcome Measurements
YMRS, MADRS Cognitive Testing, Serum BDNF
Results
A double-blind, placebo-controlled study, using an enriched maintenance design, was conducted using tianeptine in addition to treatment for bipolar depression. 151 patients completed 8 weeks of open phase treatment of tianeptine. A significant reduction in depressive symptoms was observed after this period. At week 8, after the open-label period, 69 patients who showed response were then randomized to add-on treatment with tianeptine or placebo. No statistical differences between these two groups were observed.
Publication
N/A
Link
N/A
PI Name
Flavio Kapczinski
Degree
MD
Center
Laboratorio de Psiquiatria Molecular, Centro de Pesquisa
Institution
Federal University, UFRGS, Brazil
Address
Department of Psychiatry, Hospital de Clinicas, Ramiro Barcelos 2340
City or Town
Porto Alegre
State or Province
RS
Zip or Postal Code
90035-003
Country
Brazil
Email Address
kapcz@terra.com.br