Efficacy of Adjunctive Tianeptine in the Treatment of Bipolar Depression

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital de Clinicas de Porto Alegre
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico; Stanley Medical Research Institute
• Treatments: Tianeptine

Criteria

Inclusion Criteria:

• To be included patients will be required to:

• Meet DSM-IV criteria for bipolar disorder types I or II

• Have current symptoms of depression, with a MADRS score over 12 at baseline

• Have the capacity to consent to the study and comply with the study procedures

• Use effective contraception in the case of women of childbearing age

• Patients will need to be in a stable dose of mood stabilizer for at least one month prior to randomization.

Exclusion Criteria:

• Exclusion from the trial includes:

• Patients with a well defined or suspected clinically unstable systemic medical conditions

• Pregnant or lactating women

• Patients who are currently taking augmentation medications or supplementation

• Patients who do not tolerate the use of tianeptine

• Inability to comply with either the requirements or informed consent of the treatment protocol.

• Withdrawal criteria:

• Withdrawal from the trial will take place whenever:

• Patients stop taking medication or are deemed as non compliant by the attending physician

• Patients stop taking contraceptives of become pregnant

• Dose changes or additions/exclusions to existing medication - patients will be kept in the trial, but such changes will be computed as a primary outcome

• Serious adverse reactions

• Withdrawal of consent by the patient

• Hospitalization