Trial · NCT07412132
Evaluation of the Efficacy, Safety, and Tolerability of Lacosamide in Major Depressive Episodes of Bipolar Disorder Types I and II.
NCT07412132, Phase 3, Recruiting, University of Sao Paulo
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of the Efficacy, Safety, and Tolerability of Lacosamide in Major Depressive Episodes of Bipolar Disorder Types I and II. Trials, record NCT07412132. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07412132
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of the Efficacy, Safety, and Tolerability of Lacosamide in Major Depressive Episodes of Bipolar Disorder Types I and II.
- NCT number
- NCT07412132
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 40 participants, estimated
- Lead sponsor
- University of Sao Paulo
- Conditions
- Bipolar Affective Disorder
- Interventions
- Lacosamide, Placebo
- First posted
- 2026-02-17
- Last updated
- 2026-02-20
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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 | 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; |
| Secondary | Secondary outcome | week 12 | Difference in remission rates (\< 7 points) 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 | Secondary outcome | week 12 | Difference in remission rates (\<11 points) 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; |
| Secondary | Secondary outcome | week 12 | Difference in side effects from the initial visit to the end of week 12 of intervention, between the lacosamide and placebo groups; |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07412132
GET https://conductscience.org/api/trials/v1/NCT07412132/registered