Actively Recruiting
Evaluation of the Efficacy, Safety, and Tolerability of Lacosamide in Major Depressive Episodes of Bipolar Disorder Types I and II: a Randomized, Double-blind, Placebo-controlled Clinical Trial
Led by University of Sao Paulo · Updated on 2026-02-20
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Sao Paulo
Lead Sponsor
L
Libbs Farmacêutica LTDA
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of lacosamide as an add-on treatment for moderate to severe major depressive episodes in adults with bipolar disorder types I and II who have not responded to at least two adequate treatments during their current episode. This randomized, double-blind, placebo-controlled pilot study aims to compare the reduction in depression symptoms between lacosamide and placebo groups over 12 weeks. Participants will receive either lacosamide or placebo tablets. Lacosamide will be given at 50 mg twice daily for the first two weeks, followed by 100 mg twice daily for the remainder of the 12-week treatment period. The study includes two groups: an active treatment group receiving lacosamide and a placebo group receiving inactive tablets that look similar to the active drug. During the study, participants will be assessed for changes in their depression severity using the Hamilton Depression Rating Scale (HAMD-17) from the beginning to the end of the 12 weeks. Researchers will also monitor side effects and adverse events to compare safety between groups. The total study duration for each participant is 12 weeks, during which their response to treatment and tolerability will be closely evaluated.
CONDITIONS
Brief Title
Evaluation of the Efficacy, Safety, and Tolerability of Lacosamide in Major Depressive Episodes of Bipolar Disorder Types I and II.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of bipolar disorder (type I or II) confirmed by structured clinical interview
- Currently experiencing a moderate or severe major depressive episode
- No response to at least two adequate pharmacological treatments for the current episode
- Age between 18 and 65 years
You will not qualify if you...
- Diagnosis of schizophrenia, dementia, intellectual disability, or organic mental disorder
- Acute suicidal thoughts as defined by specific clinical assessments
- Current depressive episode with psychotic features
- Suspected or confirmed pregnancy
- Severe or unstable medical illnesses
- History of non-response to at least 8 sessions of electroconvulsive therapy
- History of non-response to ketamine treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive Lacosamide or placebo to evaluate its efficacy, safety, and tolerability for major depressive episodes in bipolar disorder.
Weekly visits for 12 weeks
Trial Site Locations
Total: 1 location
1
Instituto de Psiquiatia (IPQ)
São Paulo, São Paulo, Brazil
Actively Recruiting
Research Team
R
Ricardo Alberto Moreno, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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