Lumateperone for Bipolar Mania
Trial Summary
What is the purpose of this trial?
This is a multicenter, randomized, double-blind, placebo-controlled, study in the acute treatment of patients with a diagnosis of bipolar I disorder with manic episodes or manic episodes with mixed features (bipolar mania), with or without psychotic symptoms, according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug Lumateperone for treating bipolar mania?
Lumateperone has been shown to be effective in treating major depressive episodes in people with bipolar I and II disorders, as it significantly improved symptoms of depression compared to a placebo in clinical trials. While the studies focus on depression, the drug's approval for bipolar depression suggests it may have potential benefits for other aspects of bipolar disorder, such as mania.12345
Is Lumateperone safe for humans?
Lumateperone, also known as Caplyta or ITI-007, is used to treat schizophrenia and depressive episodes in bipolar disorder. It has been shown to reduce inflammation and anxiety-like behavior in animal studies, suggesting it may be safe for humans, but always consult with a healthcare provider for personalized advice.678910
What makes the drug Lumateperone unique for treating bipolar mania?
Lumateperone is unique because it works differently from other drugs by targeting multiple neurotransmitter systems in the brain, which may help manage symptoms of bipolar mania more effectively. It is also known for having a favorable side effect profile compared to some traditional treatments.1112131415
Eligibility Criteria
This trial is for adults aged 18-75 with bipolar I disorder experiencing a manic or mixed episode, possibly with psychotic symptoms. They must meet DSM 5 criteria, have specific scores on the YMRS scale, and be hospitalized due to their current episode. Excluded are those with other primary psychiatric diagnoses, severe substance use disorders (except nicotine), first-time manic episodes, or significant suicidal risk.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive lumateperone 42 mg or placebo in a double-blind manner
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Lumateperone
Lumateperone is already approved in United States for the following indications:
- Schizophrenia
- Bipolar I or II disorder (bipolar depression)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Intra-Cellular Therapies, Inc.
Lead Sponsor