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Could a seizure drug lift bipolar depression?

NCT ID NCT07412132

Symptom relief Sponsor: University of Sao Paulo Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests whether adding lacosamide to standard treatment helps people with bipolar disorder who are currently in a major depressive episode. Forty adults who haven't responded to at least two prior treatments will receive either lacosamide or a placebo for 12 weeks. The study measures changes in depression scores using a standard rating scale.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lacosamide
What this could lead to
If it works, this could point toward a new add-on treatment for depression in bipolar disorder that is hard to treat.
What could go wrong
This is a small pilot study with only 40 people, so results may not apply widely. Lacosamide also carries risks like dizziness and nausea.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

bipolar disorder bipolar I disorder bipolar II disorder major affective disorder 6

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bipolar affective disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Instituto de Psiquiatia (IPQ)

    RECRUITING

    São Paulo, São Paulo, Brazil

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