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Efficacy of Adjunctive Tianeptine in the Treatment of Bipolar Depression

NCT00879372 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2013-10-08

No results posted yet for this study

Summary

One of the main challenges in the treatment of Bipolar Disorder (BD) is to achieve better functioning outcomes after syndromal recovery. Even treatment-responsive patients, who remain symptomatically well for extended periods of time, frequently demonstrate sub-threshold symptoms and continuing psychosocial morbidity and cognitive impairment. The cognitive impairment that persists during interepisode periods stands out as a major correlate of functional impairment, and may be a core aspect of the BD pathophysiology.

In this context, tianeptine stands out as a therapeutic agent with unique properties, which match most of the conditions found in BD.

This is an enriched maintenance study of the use of tianeptine as an adjunctive therapy in bipolar depression. All participants will receive tianeptine in an open label manner for a period of two months, following which they will be assigned randomly to the treatment with tianeptine or placebo in a double-blind fashion for six months. All patients will remain on treatment as usual for the duration of the trial. Along with clinical response, the investigators will prospectively evaluate the improvement in working and declarative memory, two cognitive prefrontal- and hippocampus-dependent processes, respectively, and the effects of tianeptine on serum BDNF levels.

Conditions

Interventions

DRUG

tianeptine

tianeptine 12,5mg TID

DRUG

Placebo

Placebo 12.5 mg TID

Sponsors & Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV

  • Stanley Medical Research Institute

    collaborator OTHER

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Principal Investigators

  • Flavio Kapczinski, MD,PhD · Hospital de Clinicas de Porto Alegre and UFRGS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2013-05-31
Completion
2013-12-31

Countries

  • Brazil

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00879372 on ClinicalTrials.gov