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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