Study of Lumateperone in the Treatment of Patients With Bipolar Mania
ConditionBipolar Disorder, Manic
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorIntra-Cellular Therapies, Inc.
About 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).
Eligibility criteria
Qualifiers
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 confirmed by a trained and Sponsor-approved rater using the modified Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT);
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;
Disqualifiers
Schizophrenia, schizoaffective disorder, or other psychotic disorders;
Dementia or other cognitive disorders;
Intellectual disability;
Moderate or severe substance use disorder (excluding for nicotine);
Trial design
Treatments tested in this trial
- Lumateperone
- Placebo
Treatment groups
350 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov