350 Participants Needed

Lumateperone for Bipolar Mania

Recruiting at 20 trial locations
IC
Overseen ByITI Clinical Trials
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Intra-Cellular Therapies, Inc.
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

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

Meets the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM 5) criteria for bipolar I disorder with a current episode of mania or mania with mixed features with or without psychotic symptoms, as confirmed by a trained and Sponsor-approved rater using the modified Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT)
Able to provide written informed consent before the initiation of any study specific procedures
YMRS total score ≥ 20 and a score of at least 4 on two of the following YMRS items: irritability, speech, content, and disruptive/aggressive behavior at Screening and Baseline
See 1 more

Exclusion Criteria

Has a current primary DSM 5 psychiatric diagnosis other than bipolar disorder. These include: schizophrenia, schizoaffective disorder, or other psychotic disorders; dementia or other cognitive disorders; intellectual disability; moderate or severe substance use disorder (excluding for nicotine); experiencing first manic episode
In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during the course of his/her participation in the study or: at Screening, the patient scores 'yes' on Items 4 or 5 in the Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening; at Screening, the patient has had 1 or more suicidal attempts within 2 years prior to Screening; at Baseline, the patient scores 'yes' on Items 4 or 5 in the Suicidal Ideation section of the C-SSRS since the Screening Visit; at Screening or Baseline, scores ≥ 4 on Item 10 (suicidal thoughts) on the rater administered Montgomery-Åsberg Depression Rating Scale (MADRS); considered to be an imminent danger to himself/herself or others.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive lumateperone 42 mg or placebo in a double-blind manner

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week
1 visit (in-person)

Treatment Details

Interventions

  • Lumateperone
Trial Overview The study tests Lumateperone against a placebo in patients with bipolar mania. It's a multi-center trial where participants are randomly assigned to either the medication or placebo without knowing which one they receive (double-blind). The goal is to evaluate the effectiveness of Lumateperone in acute treatment.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Lumateperone 42 mgExperimental Treatment1 Intervention
Lumateperone 42 mg capsules
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo

Lumateperone is already approved in United States for the following indications:

🇺🇸
Approved in United States as Caplyta for:
  • 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

Trials
42
Recruited
10,700+

Findings from Research

Lumateperone is an FDA-approved antipsychotic for treating major depressive episodes in type I and II bipolar disorder, showing superior efficacy compared to placebo when used alone or with mood stabilizers.
It has a unique mechanism of action with minimal dopamine-related side effects due to less than 50% D2 receptor occupancy, making it well tolerated compared to other similar medications.
Evaluating lumateperone for its use in treating depressive episodes associated with bipolar I or II disorder in adults.Abuelazm, H., Elsayed, OH., El-Mallakh, RS.[2023]
In a phase 3 study involving 377 patients with bipolar I or II disorder, lumateperone at 42 mg/day significantly improved depression symptoms compared to placebo, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) and Clinical Global Impressions Scale-Bipolar Version (CGI-BP-S).
Lumateperone was generally well tolerated, with only somnolence and nausea occurring at a higher rate than placebo, and a low incidence of extrapyramidal symptoms, indicating a favorable safety profile.
Efficacy and Safety of Lumateperone for Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder: A Phase 3 Randomized Placebo-Controlled Trial.Calabrese, JR., Durgam, S., Satlin, A., et al.[2022]
Lumateperone, approved by the FDA for schizophrenia and bipolar depression, works by partially activating dopamine D2 receptors and also affects the dopamine transporter, NMDA receptor, and serotonin transporter, which contributes to its therapeutic effects.
Clinical trials indicate that lumateperone has a favorable metabolic profile, showing less weight gain and better body measurements compared to other second-generation antipsychotics, while demonstrating efficacy and safety in treating schizophrenia and bipolar disorders.
Illuminating Hope for Mental Health: A Drug Review on Lumateperone.Tarzian, M., Ndrio, M., Chique, B., et al.[2023]

References

Evaluating lumateperone for its use in treating depressive episodes associated with bipolar I or II disorder in adults. [2023]
Efficacy and Safety of Lumateperone for Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder: A Phase 3 Randomized Placebo-Controlled Trial. [2022]
Illuminating Hope for Mental Health: A Drug Review on Lumateperone. [2023]
The efficacy of lumateperone on symptoms of depression in bipolar I and bipolar II disorder: Secondary and post hoc analyses. [2023]
The Efficacy of Lumateperone in Patients With Bipolar Depression With Mixed Features. [2023]
Lumateperone Normalizes Pathological Levels of Acute Inflammation through Important Pathways Known to Be Involved in Mood Regulation. [2023]
Impact of initiating long-acting injectable paliperidone palmitate on relapse and hospitalization in patients with bipolar I disorder: A mirror image retrospective study. [2021]
A randomized, placebo-controlled, multicenter study of divalproex sodium extended release in the treatment of acute mania. [2019]
[Brief history of the development of valproate in bipolar disorders]. [2013]
10.United Statespubmed.ncbi.nlm.nih.gov
Valproate in the treatment of bipolar disorder: literature review and clinical guidelines. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Potent synergistic in vitro interaction between nonantimicrobial membrane-active compounds and itraconazole against clinical isolates of Aspergillus fumigatus resistant to itraconazole. [2021]
Synergistic activity of the combination of falcarindiol and itraconazole in vitro against dermatophytes. [2023]
Efficacy of itraconazole as a combined continuous/pulse therapy in feline dermatophytosis: preliminary results in nine cases. [2019]
Antifungal Susceptibility Testing for Microsporum canis from Cats in Japan. [2023]
15.United Statespubmed.ncbi.nlm.nih.gov
Onychomycosis. New therapies for an old disease. [2018]
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