RecruitingNCT07412132
Lacosamide or placebo added to usual care for treatment-resistant depression in type I or II bipolarity
About this title
Evaluation of the Efficacy, Safety, and Tolerability of Lacosamide in Major Depressive Episodes of Bipolar Disorder Types I and II.
Read the official source — NCT07412132Researchers are comparing Lacosamide and placebo, tracking side effects to assess safety and tolerability in people with bipolarity.
Medication studyAges 18–65Brazil
Understand this study
What is this study about?
Researchers are comparing Lacosamide and placebo, tracking side effects to assess safety and tolerability in people with bipolarity.
Who could participate?
Listed age limits: 18 years to 65 years.
- Listed locations
- São PauloSee all locations and recruitment
- Study phase
- Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
What to know before participating
A point to clarify
This summary does not cover all risks or eligibility requirements. What risks or changes to my care would apply to me?
Things to check before joining
Study start dateStarted: January 9, 2026
- Recruitment status
- Recruiting
- Enrollment listed in the registry
- 40
- Sponsor
- University of Sao Paulo
- Sponsor type
- University
- Study type
- Drug
- Intervention type
- Drug
- Study phase
- Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
- Locations
- Brazil
- Age range
- From 18 Years to 65 Years
- Official registry ID
- NCT07412132
- Official title
Show the full official title
Evaluation of the Efficacy, Safety, and Tolerability of Lacosamide in Major Depressive Episodes of Bipolar Disorder Types I and II: a Randomized, Controlled, Double-blind, Parallel-group Clinical Trial.
Recruitment & locations
Currently recruitingA study may be recruiting, but some locations may no longer be accepting participants. Confirm availability with the research team.
São Paulo
Interested in joining this study?
Questions about this study
What is this study about?
Researchers are comparing Lacosamide and placebo, tracking side effects to assess safety and tolerability in people with bipolarity.
Who is behind this study?
The study sponsor is University of Sao Paulo, a university.
Does this study involve medication?
Yes. The study involves medication, including Lacosamide and Placebo.
Who can participate?
Listed age limits: 18 years to 65 years.
Is this study still recruiting?
The registry lists this study as recruiting.
