Adding lacosamide to treatment for major depressive episodes in bipolar I and II

Evaluation of the Efficacy, Safety, and Tolerability of Lacosamide in Major Depressive Episodes of Bipolar Disorder Types I and II: a Randomized, Controlled, Double-blind, Parallel-group Clinical Trial.

This trial will test whether adding lacosamide to a person's current medication helps reduce depressive symptoms in adults with treatment-resistant bipolar I or II depression.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Sao Paulo (other)
• Locations: 1 site (São Paulo, São Paulo)
• Trial ID: NCT07412132 on ClinicalTrials.gov

What this trial studies

This is a double-blind, randomized, parallel-group Phase 3 augmentation trial comparing lacosamide versus placebo in adults with moderate to severe major depressive episodes of bipolar I or II who have not responded to at least two adequate treatments during the current episode. Participants will continue their first- or second-line medications while receiving either lacosamide or placebo and will be followed for changes in depressive symptoms and adverse events. The primary outcome is reduction in depression rating scale scores; safety and tolerability will be monitored and compared between groups. The trial is conducted at the Instituto de Psiquiatria (IPQ) in São Paulo, Brazil.

Who should consider this trial

Good fit: Adults with bipolar disorder type I or II who are currently in a moderate to severe major depressive episode and have failed at least two adequate pharmacological treatments in the current episode are ideal candidates.

Not a fit: People with acute suicidal ideation, psychotic depression, pregnancy, severe unstable medical illness, current schizophrenia/dementia, or a prior non-response to adequate electroconvulsive therapy are unlikely to be eligible or to benefit from this treatment option.

Why it matters

Potential benefit: If effective, adding lacosamide could reduce depressive symptoms for people with treatment-resistant bipolar depression when used alongside their existing medications.

How similar studies have performed: Preliminary observational and open-label reports have suggested potential benefit of lacosamide for mood symptoms, but randomized controlled evidence is limited and this approach remains relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Diagnosis of bipolar disorder (type I or II) confirmed by structured clinical interview;
2. acute major depressive episode of moderate or severe intensity;
3. no response to at least two adequate pharmacological interventions to treat the current episode.

Exclusion Criteria:

1. Current diagnosis of schizophrenia, dementia, intellectual disability, organic mental disorder (by clinical assessment). Comorbidity with other psychiatric disorders (personality disorders, anxiety disorders, substance use disorders, eating disorders, and attention deficit disorder) will be permitted provided the primary diagnosis is bipolar disorder;
2. acute suicidal ideation (defined by HAMD-17 item 3 ≥ 3 points or by clinical assessment);
3. current depressive episode with psychotic features (by clinical assessment);
4. suspected or confirmed pregnancy;
5. severe or unstable clinical illnesses;
6. previous history of non-response to an adequate course of at least 8 sessions of electroconvulsive therapy;
7. previous history of non-response to an adequate course of ketamine treatment.

Where this trial is running

São Paulo, São Paulo

• Instituto de Psiquiatia (IPQ) — São Paulo, São Paulo, Brazil (RECRUITING)

Study contacts

• Study coordinator: Ricardo Alberto Moreno, Professor

Conditions: Bipolar Affective Disorder, lacosamide, randomized clinical trial, bipolar disorder, bipolar depression