Health TrialsbyHealthPanel

Study of Lumateperone in the Acute 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Lumateperone

    Drug

    Lumateperone 42 mg capsules administered orally, once daily

  • Placebo

    Drug

    Matching capsules administered orally, once daily

Treatment groups

350 Participants
are divided into 2 treatment groups
Group A: Lumateperone 42 mgExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Young Mania Rating Scale (YMRS)

The YMRS is an 11-item, clinician-administered mania rating scale designed to assess the severity of manic symptoms. Four of the YMRS items are rated on a 0 to 8 scale, with the remaining 7 items rated on a 0 to 4 scale. The total score ranges from 0 to 60 with a higher score indicating increased severity of manic symptoms.

Time frame
Week 3

Secondary outcomes

1

Clinical Global Impression Scale-Severity (CGI-S)

The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).

Time frame
Week 3

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Intra-Cellular Therapies, Inc.

Lead sponsor

Source ClinicalTrials.gov
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