Head-to-Head: which drug best eases bipolar depression?
NCT ID NCT07676669
First seen Jun 30, 2026 · Last updated Sep 10, 2026 · Updated 3 times
Summary
This study compares two drugs, lumateperone and cariprazine, when added to a mood stabilizer for people with bipolar I depression. Researchers will track changes in depression symptoms over 8 weeks using standard rating scales. The goal is to see which drug works better and has fewer side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lumateperone and cariprazine
- What this could lead to
- If one drug proves safer or more effective, it could become a preferred add-on treatment for bipolar depression.
- What could go wrong
- This is a single-center trial with 140 participants, so results may not apply broadly. Both drugs have known side effects, and the study may not find a clear winner.
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Patients aged 18-60 years * Diagnosed with bipolar I depression according to DSM-5 criteria * On stable dose of mood stabilizer (lithium or valproate) for at least 2 weeks * Moderate to severe depressive symptoms (baseline MADRS score ≥20) * Willing to provide informed consent Exclusion Criteria: * • Current manic or mixed episode * Rapid cycling bipolar disorder * Substance use disorder * Severe neurological illness or medical emergency * Pregnancy or lactation * Treatment-resistant depression requiring ECT * Active suicidal risk requiring emergency intervention
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
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Other studies related to the condition(s) this trial covers.