A study to assess the efficacy and safety of lumateperone in patients with Bipolar Mania

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Intra-Cellular Therapies Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

Trial duration

20 Dec 2024 → 5 Mar 2026

Decision date (initial)

2024-11-20

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Intra-Cellular Therapies, Inc. (USA)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Pharmacokinetic, Therapy

The primary efficacy objective of this study is to assess the efficacy of lumateperone 42 mg administered once daily compared with placebo in the acute treatment of patients with manic episodes or manic episodes with mixed features associated with bipolar I disorder, as measured by change from baseline to end of Week 3 in Young Mania Rating Scale (YMRS) total score.

Secondary objectives 1

1. The key secondary efficacy objective of this study is to assess the efficacy of lumateperone 42 mg administered once daily compared with placebo in the acute treatment of patients with manic episodes or manic episodes with mixed features associated with bipolar I disorder, as measured by change from baseline to end of Week 3 in Clinical Global Impression-Severity (CGI-S) score.

Conditions and MedDRA coding

Bipolar I Disorder (Bipolar Mania)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Patient provides written informed consent.
2. Male or female inpatient, between the ages of 18 and 75 years, inclusive
3. Meets the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, Text Revision 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);and meets all of the following criteria: a. The start of the current manic or manic with mixed features episode is ≤ 4 weeks prior to Screening (Visit 1); b. 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 (Visit 1) and Baseline (Visit 2); c. Have at least moderate severity of illness based on CGI-S total score ≥ 4 at Screening (Visit 1) and Baseline (Visit 2);
4. Hospitalized voluntarily before Screening (Visit 1) or admitted to inpatient unit at Visit 1 with a primary diagnosis of mania but not > 14 days before Screening (Visit 1). Hospital admission must be a result of the current manic episode

Exclusion criteria 5

1. 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)
2. Experiencing first manic episode
3. 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 (Visit 1), 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 (Visit 1), the patient has had 1 or more suicidal attempts within 2 years prior to Screening (Visit 1); or - At Baseline (Visit 2), the patient scores “yes” on Items 4 or 5 in the Suicidal Ideation section of the C-SSRS since the Screening Visit; or o At Screening (Visit 1) or Baseline (Visit 2), 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
4. The patient has received electroconvulsive therapy (ECT), vagal nerve stimulation, or repetitive trans-cranial magnetic stimulation within the past 1 year
5. The patient has known hypersensitivity or intolerance to lumateperone, or to any of the excipients

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline to end of Week 3 in YMRS total score

Secondary endpoints 1

1. Change from baseline to end of Week 3 in CGI-S score

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Intra-Cellular Therapies Inc.

Sponsor organisation

Intra-Cellular Therapies Inc.

Address

430 East 29th Street Suite 900

City

New York

Postcode

10016-8367

Country

United States

Scientific contact point

Organisation

Intra-Cellular Therapies Inc.

Contact name

ITI Clinical Trials

Public contact point

Organisation

Intra-Cellular Therapies Inc.

Contact name

ITI Clinical Trials

Third parties 7

Locations

2 EU/EEA countries · 13 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 61 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

9 submissions — initial application plus substantial / non-substantial modifications