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Evaluation of the Efficacy, Safety, and Tolerability of Lacosamide in Major Depressive Episodes of Bipolar Disorder Types I and II.

RecruitingPhase 3Ages 18 Years - 65 YearsAllUniversity of Sao Paulo
NCT07412132 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Initially, observational studies suggested a possible effect of Lacosamide on depressive and anxious symptoms in individuals with epilepsy, and later, an open-label study demonstrated the efficacy of lacosamide in improving depressive and manic symptoms in individuals with bipolar disorder (BD). The primary objective of this study is to evaluate the efficacy of combining lacosamide as an augmentation treatment to first- or second-line medication treatments in moderate to severe major depressive episodes of treatment-resistant BD I and II (failure of at least two adequate treatments during the current episode). The main hypothesis of the study is that lacosamide produces a greater reduction in depression scores compared to a placebo treatment and that both groups will exhibit similar rates of side effects and adverse events. We will conduct a double-blind, randomized, parallel-group pilot

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📋 Eligibility rules (as published)
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.
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What it tests

  • Lacosamide
  • Placebo
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Where

1 site
Instituto de Psiquiatia (IPQ)
São Paulo, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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