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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Instituto de Psiquiatia (IPQ)
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Study coordinator: Ricardo Alberto Moreno, Professor
• Email: grudaipq@hc.fm.usp.br
• Phone: +55 11 2661-6648

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Quality of life and safety in quetiapine use for schizophrenia or bipolar disorder

  This study looks at how patients with schizophrenia or bipolar disorder feel and stay safe when treated with quetiapine alone or with other antipsychotics.

  Recruiting Bosnalijek D.D · Sarajevo · NCT07858565

• EEG microstates and inflammatory biomarkers in older adults with major depression receiving ECT

  This study tests how ECT affects brain wave patterns and inflammatory markers in people 55 and older with major depression.

  Recruiting Istanbul University - Cerrahpasa · Istanbul, Bakırköy · NCT07740694

• Melatonin versus placebo for bipolar disorder

  This 6-month trial will try adding melatonin to usual treatment for adults with bipolar disorder to see if it improves sleep and mood stability.

  Recruiting Phase 2 University Hospital Bispebjerg and Frederiksberg · Frederiksberg · NCT07472075

• Self-regulation techniques to test in a woman with ADHD and stabilized bipolar disorder

  This study tests six short, 15-minute self-regulation techniques to see how they affect heart rate, mood, brain activity, and memory in a woman with ADHD and stabilized bipolar disorder.

  Recruiting Poznan University of Physical Education · Poznan · NCT07437833

• Medical and psychiatric profiling of adults admitted to general adult psychiatry wards

  This project will collect questionnaires, rating scales, and case-note information from adults admitted to general adult psychiatry wards to see what their physical and mental health profiles look like.

  Recruiting University of Edinburgh · Livingston, West Lothian · NCT07398365

• Using AI to Improve Rehabilitation for Patients with Severe Mental Disorders

  This study is testing if using AI and fun games can help people with severe mental disorders improve their social skills and get back into the community.

  Recruiting Shanghai Mental Health Center · Shanghai · NCT06904079

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.