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Tests treatment safety and results for Bipolar Affective Disorder
Official title Evaluation of the Efficacy, Safety, and Tolerability of Lacosamide in Major Depressive Episodes of Bipolar Disorder Types I and II.
ClinicalTrials.gov ID: NCT07412132
What this study is testing
What is Lacosamide?
Lacosamide is an investigational medicine, given as a twice-daily, being studied as a potential treatment for bipolar affective disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join 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 likely can't join if
- Current diagnosis of schizophrenia, dementia, intellectual disability, organic mental disorder (by clinical assessment). Comorbidity with other...
- 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;
See the full eligibility criteria
- 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.
- Current diagnosis of schizophrenia, dementia, intellectual disability, organic mental disorder (by clinical assessment). Comorbidity with other psychiatric disorders (personality disorders, anxiety disorders, substance...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.