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

NCT07412132 | Recruiting Phase 3

• 1 other identifier: Lacosamide on bipolar disorder
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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 study, comparing the enhancement of the treatment that patients had been using with lacosamide and placebo, over a duration of 12 weeks. Forty subjects aged between 18 and 65 years with a diagnosis of BD (I or II) in a moderate or severe major depressive episode, despite the use of first- or second-line treatments, will be selected. The primary outcome will be the assessment of lacosamide efficacy through the difference in scores on the Hamilton Depression Rating Scale (HAMD-17) from the initial visit to the end of week 12 of intervention between the lacosamide and placebo groups.

Conditions

Bipolar Affective Disorder

Keywords

lacosamide; randomized clinical trial; bipolar disorder; bipolar depression

Outcome Measures

Primary Outcomes (1)

• Primary outcome

  The efficacy of lacosamide assessed by the difference in Hamilton Depression Scale score from the initial visit to the end of week 12 of the intervention between the lacosamide and placebo groups. Minimum: 0 point Maximum: 50 points. The increase in the pontuation of the scale is related to worse outcomes.

  week 12

Secondary Outcomes (5)

• Secondary Outcome

  week 12

• Secondary outcome

  week 12

• Secondary outcome

  week 12

• Secondary outcome

  week 12

• Secondary outcome

  week 12

Study Arms (2)

Active Group

EXPERIMENTAL

Lacosamide 50mg twice a day

Drug: Lacosamide

Placebo Group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Lacosamide DRUG

Lacosamide 50mg will be give twice a day por 2 weeks, then Lacosamide 100mg twice a day until the end of the study.

Active Group

Placebo DRUG

Placebo tablets are similar in its features to the active drug, but without any pharmacological agent inside.

Placebo Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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;
• acute suicidal ideation (defined by HAMD-17 item 3 ≥ 3 points or by clinical assessment);
• current depressive episode with psychotic features (by clinical assessment);
• suspected or confirmed pregnancy;
• severe or unstable clinical illnesses;
• previous history of non-response to an adequate course of at least 8 sessions of electroconvulsive therapy;
• previous history of non-response to an adequate course of ketamine treatment.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Libbs Farmacêutica LTDA: collaborator

Study Sites (1)

Instituto de Psiquiatia (IPQ)

São Paulo, São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Lacosamide

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids

Central Study Contacts

Ricardo Alberto Moreno, Professor

CONTACT

+55 11 2661-6648; grudaipq@hc.fm.usp.br

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: Doctorate

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 17, 2026
• Study Start: January 9, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)