Status:
UNKNOWN
Efficacy of Adjunctive Tianeptine in the Treatment of Bipolar Depression
Lead Sponsor:
Hospital de Clinicas de Porto Alegre
Collaborating Sponsors:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Stanley Medical Research Institute
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 ...
Detailed Description
One of the main challenges in the treatment of Bipolar Disorder (BD) is to achieve better functioning outcomes after syndromal recovery. Available treatments are reasonably effective in reducing acute...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00879372
Start Date
March 1 2009
End Date
December 1 2013
Last Update
October 8 2013
Active Locations (1)
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1
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-003