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New treatment option for Bipolar Disorder, Manic
Official title Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania
ClinicalTrials.gov ID: NCT06462586
What this study is testing
What is Lumateperone?
Lumateperone is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for bipolar disorder, manic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Able to provide written informed consent before the initiation of any study specific procedures;
- Male or female inpatient, between the ages of 18 and 75 years, inclusive;
- Meets the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM 5) criteria for bipolar I disorder with a current episode of mania...
- 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...
- Hospitalized voluntarily before Screening or admitted to inpatient unit at Visit 1 with a primary diagnosis of mania but not \> 14 days before...
You likely can't join if
- 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;
See the full eligibility criteria
- Able to provide written informed consent before the initiation of any study specific procedures;
- Male or female inpatient, between the ages of 18 and 75 years, inclusive;
- 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...
- 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;
- Hospitalized voluntarily before Screening or admitted to inpatient unit at Visit 1 with a primary diagnosis of mania but not \> 14 days before Screening. Hospital admission must be a result of the current manic episode.
- 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; or
- At Screening, the patient has had 1 or more suicidal attempts within 2 years prior to Screening; or
- At Baseline, the patient scores "yes" on Items 4 or 5 in the Suicidal Ideation section of the C-SSRS since the Screening Visit; or
- At Screening or Baseline, scores ≥ 4 on Item 10 (suicidal thoughts) on the rater administered Montgomery-Åsberg Depression Rating Scale (MADRS); or
- Considered to be an imminent danger to himself/herself or others.
The study team makes the final eligibility decision.
Where it's taking place
- Rogers, Arkansas, United States
- Bellflower, California, United States
- Culver City, California, United States
- Garden Grove, California, United States
- Lemon Grove, California, United States
- Montclair, California, United States
- Hallandale, Florida, United States
- Hialeah, Florida, United States
- Miami, Florida, United States
- Miami Gardens, Florida, United States
- Miami Lakes, Florida, United States
- Miami Springs, Florida, United States
- Orlando, Florida, United States
- Atlanta, Georgia, United States
- Decatur, Georgia, United States
- Savannah, Georgia, United States
- Shreveport, Louisiana, United States
- Marlton, New Jersey, United States
- North Canton, Ohio, United States
- Austin, Texas, United States
+ 19 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rogers, Arkansas, United States; Bellflower, California, United States; Culver City, California, United States; Garden Grove, California, United States; Lemon Grove, California, United States; Montclair, California, United States and 33 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.