Bipolar Affective Disorder
Conditions
Keywords
lacosamide, randomized clinical trial, bipolar disorder, bipolar depression
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.
Interventions
DRUGLacosamide
Lacosamide 50mg will be give twice a day por 2 weeks, then Lacosamide 100mg twice a day until the end of the study.
DRUGPlacebo
Placebo tablets are similar in its features to the active drug, but without any pharmacological agent inside.
Sponsors
University of Sao Paulo
Libbs Farmacêutica LTDA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary outcome | week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcome | week 12 | Difference in response rates (50% or more reduction) assessed by the Hamilton Depression Scale from the initial visit to the end of week 12 of intervention, between the lacosamide and placebo groups; |
| Secondary outcome | week 12 | Difference in response rates (50% or more reduction) assessed by the Montgomery-Asberg Depression Rate Scale from the initial visit to the end of week 12 of intervention, between the lacosamide and placebo groups; |
Countries
Brazil
Contacts
CONTACTRicardo Alberto Moreno, Professor
Outcome results
None listed