Efficacy of Adjunctive Tianeptine in the Treatment of Bipolar Depression

NCT00879372 | Unknown Phase 3

• 1 other identifier: 08-145
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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

Bipolar Disorder

Keywords

Bipolar Disorder; cognitive impairment; depression

Outcome Measures

Primary Outcomes (1)

• Improvement in mood symptoms (Hamilton depression rating scale)

  @ 4 weeks and @ 8 months

Secondary Outcomes (1)

• Cognitive improvement

  @ 4 weeks and @ 8 months

Study Arms (2)

1

PLACEBO COMPARATOR

Placebo

Drug: Placebo

2

ACTIVE COMPARATOR

Tianeptine

Drug: tianeptine

Interventions

tianeptine DRUG

tianeptine 12,5mg TID

Also known as: Stablon (Servier)

2

Placebo DRUG

Placebo 12.5 mg TID

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Serious adverse reactions
• Withdrawal of consent by the patient
• Hospitalization

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Stanley Medical Research Institute: collaborator

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

MeSH Terms

Conditions

Bipolar Disorder; Cognitive Dysfunction; Depression

Interventions

tianeptine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders; Behavioral Symptoms; Behavior

Study Officials

• Flavio Kapczinski, MD,PhD

  Hospital de Clinicas de Porto Alegre and UFRGS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 9, 2009
• First Posted: April 10, 2009
• Study Start: March 1, 2009
• Primary Completion: May 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 8, 2013

Record last verified: 2013-10

Locations

BR (1)