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CTRI Number  CTRI/2025/03/082366 [Registered on: 17/03/2025] Trial Registered Prospectively
Last Modified On: 29/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to assess the effectiveness and safety of Lumateperone as another treatment in Patients with Bipolar I Disorder (Bipolar Mania) 
Scientific Title of Study   A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Lumateperone in the Acute Treatment of Patients with Manic Episodes or Manic Episodes with Mixed Features Associated with Bipolar I Disorder (Bipolar Mania). 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
ITI-007-451 Amendment 2, dated 03 Jul 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Shweta Pradhan 
Designation  Head Clinical Operations, India 
Affiliation  IQVIA RDS (India) Private Limited 
Address  Omega Embassy Tech Square, Marathahalli - Sarjapura, Outer Ring Road, Kadubeesanahalli, Bengaluru

Bangalore
KARNATAKA
560103
India 
Phone  9513774664  
Fax    
Email  shweta.pradhan@iqvia.com  
 
Details of Contact Person
Public Query  
Name  Shweta Pradhan 
Designation  Head Clinical Operations, India 
Affiliation  IQVIA RDS (India) Private Limited 
Address  Omega Embassy Tech Square, Marathahalli - Sarjapura, Outer Ring Road, Kadubeesanahalli, Bengaluru

Bangalore
KARNATAKA
560103
India 
Phone  9513774664  
Fax    
Email  shweta.pradhan@iqvia.com  
 
Source of Monetary or Material Support  
Intra-Cellular Therapies, Inc. Alexandria Center for Life Science 430 East 29th Street New York, NY 10016, USA 
 
Primary Sponsor  
Name  Intra-Cellular Therapies, Inc. 
Address  Alexandria Center for Life Science 430 East 29th Street New York, NY 10016, USA 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
IQVIA RDSIndia Pvt Ltd  Omega Embassy TechSquare, Marathahalli-Sarjapur Outer Ring Road, Kadubeesanahalli, Bangalore – 560103, Karnataka 
 
Countries of Recruitment     Bulgaria
Croatia
India
Serbia
United States of America  
Sites of Study
Modification(s)  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shrinivasa Bhat U  Centre for Psychiatric Research, Department of Psychiatry, K.S. Hegde Hospital  , K.S. Hegde Medical Academy, Nitte (Deemed to be University), K.S. Hegde Medical Sciences Complex, Deralakatte, Mangaluru- 575 018,
Dakshina Kannada
KARNATAKA 		 9845204136

shrinivasabhat@yahoo.co.in 
Dr Umesh Sureshrao Nagapurkar  Chopda Medicare & Research Centre Pvt. Ltd  Magnum Heart Institute, 3/5, Patil Lane No. 1, Laxmi Nagar, Near K.B.H. Vidyalaya, Canada Corner, Nashik-422005, Maharashtra, India
Nashik
MAHARASHTRA 		 919823146088

umeshanjali@gmail.com 
Dr Navkiran Mahajan  Dayanand Medical College & Hospital  Department of Psychiatry, Civil Lines, Tagore Nagar, 141001
Ludhiana
PUNJAB 		 9872655008

drnavkiran@yahoo.co.in 
Dr Rashmi Shukla  Department of Psychiatry King George’s Medical University Chowk  King George’s Medical University, King George’s Medical University, Shah Mina Road, Chowk, Lucknow-226003, UP, India
Lucknow
UTTAR PRADESH 		 9935657064

drrashmikgmu06@gmail.com 
Dr Deepanjali Medhi  Gauhati Medical College and Hospital   GMC Hospital Road, Bhangagarh Guwahati -781032, Assam India
Kamrup
ASSAM 		 9435115263

dr.jonali09@gmail.com 
Dr Narendra Kumar M S  K R Hospital attached to Mysore Medical College and Research Institute   Department of Psychiatry, K R Hospital attached to Mysore Medical College and Research Institute, Irwin Road, Mysuru-570001, Karnataka, India
Mysore
KARNATAKA 		 9451518612

krlabsinfo@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Central Ethics Committee NITTE (Deemed to be University), University Enclave, Medical Sciences Complex, Deralakatte, Mangalore-575 018, Karnataka, INDIA   Submittted/Under Review 
Drug Trial Ethics Committee  Approved 
Institutional Ethics Committee King George’s Medical University, King George’s Medical University, Shah Mina Road, Chowk, Lucknow-226003, UP, India  Submittted/Under Review 
Institutional Ethics Committee and Hospital 1st Floor Department of Psychiatry GMC Hospital Road, Bhangagarh Guwahati -781032 Assam India  Submittted/Under Review 
Institutional Ethics Committee-Mysore Medical College and Research Institute and Associated Hospitals Mysore Medical College and Research Institute, Irwin Road, Mysuru-570001, Karnataka, India  Submittted/Under Review 
Magna-Care Ethics Committee Chopda Medicare and Research Centre Pvt. Ltd; Magnum Heart Institute, Canada Corner, Nashik-422005, Maharashtra, India  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F316||Bipolar disorder, current episodemixed,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lumateperone  Route: Oral Dose: Formulated Capsules (42 mg) Frequency: Once daily in the evening  
Comparator Agent  Placebo  Route: Oral Dose Formulation: capsule Frequency: Once daily in the evening 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Provide written informed consent before the initiation of any study-specific procedures.
2. Male or female inpatient, between the ages of 18 and 75 years, inclusive.
3. Meets the Diagnostic and Statistical Manual of Mental Disorders, (DSM-5-TR, American Psychiatric Association, 2022) 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 greater than 14 days before Screening (Visit 1). Hospital admission must be a result of the current manic episode.
5. Female of childbearing potential and agrees to use at least an acceptable method of birth control (including but not limited to hormonal contraception, intrauterine device, vasectomized partner, bilateral tubal occlusion, condom with or without spermicide, cap with spermicide, diaphragm with spermicide, sponge with spermicide, or double barrier methods) from the time informed consent is provided through the end of the SFU period. Abstinence may be an acceptable form of birth control based on the Investigator’s judgment and familiarity with the patient’s “preferred and usual lifestyle
6. Ability to follow study instructions and likely to complete all required visits 
 
ExclusionCriteria 
Details  1. Has a current primary DSM-5 psychiatric diagnosis other than bipolar disorder. These include:
a. Schizophrenia, schizoaffective disorder, or other psychotic disorders.
b. Dementia or other cognitive disorders.
c. Intellectual disability.
d. 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
a. 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
b. At Screening (Visit 1), the patient has had 1 or more suicidal attempts within 2 years prior to Screening (Visit 1); or
c. 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
d. At Screening (Visit 1) or Baseline (Visit 2), scores less than or equal to 4 on Item 10 (suicidal thoughts) on the rater administered Montgomery-Ã…sberg Depression Rating Scale (MADRS); or
e. Considered to be an imminent danger to himself/herself or others. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
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.  3 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
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.  3weeks 
 
Target Sample Size   Total Sample Size="350"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  19/06/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="1"
Days="5" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This is a global, 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).

The study will be conducted in 3 phases:

 Screening Period (up to 1 week) during which patient eligibility will be assessed;

 Double-blind Treatment Period (3 weeks) during which all eligible patients will be randomized to receive lumateperone 42 mg or placebo in 1:1 ratio.

Safety Follow-up Period (1 week) during which all patients will return to the clinic for a safety follow-up (SFU) Visit approximately one week after the end of DBTP, or ET Visit if the patient does not complete the DBTP.

 
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