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CTRI Number  CTRI/2025/05/087417 [Registered on: 22/05/2025] Trial Registered Prospectively
Last Modified On: 14/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia or Bipolar Disorder 
Scientific Title of Study   An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone in the Treatment of Pediatric Patients with Schizophrenia, Bipolar Disorder, or autism spectrum disorder 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
ITI-007-321 India Original Protocol Dated 01 Oct 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  Dir, Clinical Opns Clinical Operations 
Affiliation  IQVIA RDS (India) Private Limited 
Address  Omega Embassy Tech Square, Marathahalli - Sarjapura, Outer Ring Road, Kadubeesanahalli, Bengaluru

Bangalore
KARNATAKA
560103
India 
Phone  919833992566  
Fax    
Email  shweta.pradhan@iqvia.com  
 
Details of Contact Person
Public Query  
Name  Shweta Pradhan 
Designation  Dir, Clinical Opns Clinical Operations 
Affiliation  IQVIA RDS (India) Private Limited 
Address  Omega Embassy Tech Square, Marathahalli - Sarjapura, Outer Ring Road, Kadubeesanahalli, Bengaluru


KARNATAKA
560103
India 
Phone  919833992566  
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 
 
Primary Sponsor  
Name  Intra-Cellular Therapies, Inc.  
Address  Alexandria Center for Life Science 430 East 29th Street New York, NY 10016  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
IQVIA RDS INDIA PRIVATE LIMITED  Omega Embassy Tech Square, Marathahalli - Sarjapura, Outer Ring Road, Kadubeesanahalli, Bengaluru, Karnataka – 560103 
 
Countries of Recruitment     India
Serbia
United States of America  
Sites of Study
Modification(s)  
No of Sites = 12  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chandrashekar T R  Belagavi Institute of Medical Sciences  Dr. B R Ambedkar Road, Belgavi-590001
Belgaum
KARNATAKA 		 9611427666

drtrcshekar007@gmail.com 
Dr Shailesh Pangaonkar  Central Institute of Behavioral Sciences  Srividya, 8, Nawab Layout, Tilak Nagar, Nagpur – 440010
Nagpur
MAHARASHTRA 		 9423105228

pangaokar11@gmail.com 
Dr P N Suresh Kumar  Chethana Centre For Neuropsychiatric Rehabilitation  Providence College Road, Malaparamba, Kozhikode
Kozhikode
KERALA 		 9447218825

drpnsuresh@gmail.com 
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
Nashik
MAHARASHTRA 		 9823146088
0253-2313613
umeshanjali@gmail.com 
Dr Venu Gopal Jhanwar  Deva Institute of Healthcare and Research Pvt. Ltd   B 27/70MN, Durgakund, Varanasi-221005
Varanasi
UTTAR PRADESH 		 9935571052

vgj.dihr@gmail.com 
Dr Sandip Hasmukhlal Shah  GMERS Medical College And Hospital  #204,2nd Floor, Hospital Building, Department Of Psychiatry, Gmers Medical College And Hospital, Gotri Road, Gotri, Vadodara-390021
Vadodara
GUJARAT 		 9824060683

hod.psy.gotri@gmail.com 
Dr Parth Singh Meena  Jawahar Lal Nehru Medical College  Kala Bagh, Ajmer, Rajasthan – 305001
Ajmer
RAJASTHAN 		 9414456991

doctor.parth@outlook.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
Mysore
KARNATAKA 		 9451518612

drheggere@gmail.com 
Dr Vaishal Nareshchandra Vora  Ratandeep Multispecialty Hospital  Nakshatra Complex,Above HDFC Bank,Maninagar Cross roads, Ahmedabad- 380008
Ahmadabad
GUJARAT 		 9825440891

vnvora@gmail.com 
Dr Shri Gopal Goyal  S.P. Medical College & A.G. of Hospitals  Room No. 18-A, First Floor, Department of Psychiatry, S.P. Medical College & A.G. of Hospitals, Bikaner – 334001
Bikaner
RAJASTHAN 		 8947825749

shriigopalgoyal@gmail.com 
Dr Vinay Barhale  Society for Psychiatric Update and Research (SPUR)  Shanti Nursing Home Kanchanwadi, Paithan Road, Chhatrapati Sambhajinagar (Aurangabad)-431005
Aurangabad
MAHARASHTRA 		 9860798041

drvinay@shantinursinghome.com 
Dr Ravisha Thunga Airody  Vinaya Hospital & Research Center   Karangalpady, Mangaluru – 575003
Dakshina Kannada
KARNATAKA 		 9964337697

ravishthunga@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
Chethana Centre for Neuropsychiat Ric_ Dr. P N Suresh Kumar  Approved 
DMHC Ethics Committee_Dr. Venu Gopal Jhanwar   Submittted/Under Review 
Ethics Committee Shanti Nursing Home_Dr. Vinay Barhale  Approved 
Ethics Committee Vinaya Hospital_Dr. Ravisha Thunga Airody  Submittted/Under Review 
Ethics Committee, S.P Medical College   Approved 
Institution Ethics Committee_ Dr. Chandra Shekar T R  Submittted/Under Review 
Institutional Ethics Committee_Dr. Narendra Kumar M S  Submittted/Under Review 
Institutional Ethics Committee_Dr. Parth Singh Meena  Submittted/Under Review 
Institutional Ethics Committee_Dr. Shailesh Pangaonkar  Submittted/Under Review 
Institutional Human Ethics Committee_Dr. Sandip HasmukhLal Shah  Submittted/Under Review 
Magna-Care Ethics Committee_ Dr. Umesh Sureshrao Nagapurkar  Approved 
Ratandeep Institutional Ethics Committee_Dr. Vaishal Nareshchandra Vora  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F208||Other schizophrenia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparator is not applicable in the study  Comparator is not applicable in the study 
Intervention  Lumateperone  Dose: once daily Route: oral Duration: The maximum per-patient study duration will be approximately 28 weeks  
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  17.00 Year(s)
Gender  Both 
Details  1. All patients must have an LAR (eg parent or legal guardian) who is willing and able to be responsible for the safety and well-being of the patient, provide information about the patients condition, and accompany the patient to study visits.
NOTE: Patients who turn 18 years of age during their participation in this OL safety study will be allowed to continue for the duration of this trial. In addition, patients who turn 18 years of age during a lead-in efficacy study will be allowed to enroll and continue for the duration of this trial.
2. The LAR must provide written, informed consent. If a patient turns the age of majority (generally, age 18 years in most jurisdictions) during study participation, they should sign the informed consent at the visit following their birthday.
3. The patient must provide written assent, if developmentally appropriate.
4. Male or female patients must have a DSM-5-TR primary diagnosis of bipolar I or bipolar II disorder and meet the following:
a. Patients must complete the bipolar disorder lead-in efficacy study (Study ITI-007-421).
b. Patients must be aged 10 to 17 years at Screening of the lead-in study. In this India original protocol, only patients aged 13 to 17 years will be eligible for enrollment.
NOTE: At a later date when data are available to support dose selection, this protocol will be amended to also include patients aged 10 to 12 years with bipolar disorder.
5. Is currently an outpatient and is anticipated to maintain outpatient status for the duration of the study.
6. Female patients of childbearing potential must have negative urine pregnancy test at Visit 8 of lead in Study ITI-007-421 and: a. Are not sexually active and agree to remain abstinent from Baseline through the SFU Period, or b. Agree to use at least an acceptable contraceptive method (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 Baseline through the SFU Period. NOTE: If a female patient reaches menarche during the study, the Investigator should have an age-appropriate discussion with the patient and LAR to determine if contraceptive requirements (as noted above) are met.
8. Male patients who have reached spermarche must meet one of the following criteria: a. Are not sexually active and agree to remain abstinent from Baseline through the SFU Period, or b. Agree to use at least an acceptable contraceptive method from Baseline through the SFU period. NOTE: If a male patient experiences spermarche during study participation, the Investigator should have an age-appropriate discussion with the patient and LAR to determine if contraceptive requirements (as noted above) are met.
9. Body mass index (BMI) greater than the 5th percentile at Baseline based on age- and gender-specific CDC Clinical Growth Charts (2000);
10. Ability to swallow capsules;
11. Ability to follow study instructions and likely to complete all required visits 
 
ExclusionCriteria 
Details  A patient who meets any of the following exclusion criteria will not be eligible for enrollment in this study.
Psychiatric Exclusion Criteria:
1. Has a primary psychiatric diagnosis other than bipolar I or bipolar II disorder. Patients with bipolar disorder with psychotic features are not allowed. Note: An exception includes attention deficit hyperactivity disorder (ADHD): If a patient is taking medication(s) for ADHD, they must have been on a stable treatment regimen of these medication(s) for 30 days prior to Screening. The treatment regimen should remain stable throughout the study. This must be confirmed by the Investigator and noted in the source records.
2.In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or a. At Baseline (Visit 2), the patient scores “yes” on Suicidal Ideation Items 3, 4, or 5 of the Columbia–Suicide Severity Rating Scale (C-SSRS) since the previous visit; or b. At Baseline (Visit 2), scores greater than 3 on Item 13 (suicidal ideation) of the CDRS-R; or c. The patient is considered to be an imminent danger to him/herself or others.
Treatment-related Exclusion Criteria:
3. Received electroconvulsive therapy (ECT), vagal nerve stimulation, repetitive transcranial magnetic stimulation, or any other neuromodulation therapies for any central nervous system and psychiatry indications within 6 months prior to Baseline (Visit 2);
4. History of clinically significant drug allergy or sensitivity, including a known sensitivity or idiosyncratic reaction to lumateperone or drugs of the same class, or any compound listed in the study formulation;
5. Use of any strong or moderate cytochrome P450 3A4 inhibitor or any P450 3A4 inducer within 7 days prior to Baseline (Visit 2);
6. Use of monoamine oxidase inhibitors within 14 days prior to Baseline (Visit 2);
7. Use of clozapine within 3 months prior to Baseline (Visit 2)
8. Use of antipsychotics which cannot be discontinued prior to Baseline (Visit 2).
9. The patient had a positive test for drugs of abuse (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, or opioids/opiates) or alcohol at the most recent available lead-in study assessment. Exceptions may be made for appropriate prescription medication use.
10. The patient has received a depot antipsychotic within 2 treatment cycles prior to Baseline (Visit 2)
11. The patient is unable to be safely discontinued from prohibited medications (in the opinion of the Investigator).
12. The patient has had exposure to any investigational product within 3 months of Baseline (Visit 2) (except for those patients who had participated in the lead-in study) or participated in the past 3 years in greater than 2 clinical studies of an investigational product with a central nervous system indication;
Other Medical Exclusion Criteria
13. Female patient who is currently pregnant or breastfeeding;
14. Based on the most recent available assessment from the lead-in study, the patient has abnormal laboratory values or clinical findings that are judged to be clinically significant including, but not limited to:
a. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than 2 × the upper limit of normal (ULN);
b. Total bilirubin greater than ULN
c. Hemoglobin less than 8 g/dL (80 g/L) for females and less than 9 g/dL (90 g/L) for males;
d. Absolute neutrophil count (ANC) less than 1200 cells/µL (1.2 × 109 /L);
e. Thyroid-stimulating hormone (TSH) outside of the normal reference range and clinically significant, as determined by the Investigator. Free T3 and free T4 will be measured if TSH level is out of range. The patient will be excluded if the free T3 or free T4 level is out of range;
f. HbA1c greater than 6.5% [greater than 48 mmol/mol];
g. Positive test for hepatitis B surface antigen and/or hepatitis B core antibody immunoglobulin M at Screening (Visit 1) of the lead-in study; positive hepatitis C antibody at Screening (Visit 1) of the lead-in study, with the exception of a patient for whom the reflex HCV RNA test is negative;
h. Any other clinically significant abnormal laboratory result
15. History of human immunodeficiency (HIV) infection;
16. From the most recent assessment from a lead-in study, history of a clinically significant cardiac disorder and/or abnormal electrocardiogram (ECG) or a QT interval corrected for heart rate using Fridericia formula (QTcF) greater than 460 msec;
17. Clinically significant abnormality within 2 years of Baseline that in the Investigator’s opinion may place the patient at risk or interfere with study outcome variables; this includes, but is not limited to, history of other clinically significant neurologic, hepatic, renal, gastrointestinal, respiratory, hematologic, endocrine, or immunologic disease or history of malignancy
18. Patients with a history of orthostatic hypotension or who have orthostatic hypotension (defined as reduction of greater than or equal to 20 mm Hg in systolic blood pressure [SBP] or a reduction of greater than or equal to 10 mm Hg in diastolic blood pressure [DBP] while changing from the supine to standing position) at the most recent available assessment from the lead-in study;
19. Surgical or medical condition (active or chronic) that in the Investigator’s opinion may interfere with drug absorption, distribution, metabolism, or excretion of the study drug or any other condition that may place the patient at risk;
Additional Exclusions
20. The patient is judged by the Investigator to be inappropriate for the study;
21. The patient is an employee of the Investigator or study site, or immediate family (ie, child, or sibling, whether biological or legally adopted) of such employees, the Investigator, the Sponsor, or contract research organizations (CROs) conducting the study.

 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the safety and tolerability of lumateperone administered orally once daily for approximately 26 weeks in pediatric patients aged 10 to 17 years with bipolar disorder.  To evaluate the safety and tolerability of lumateperone administered orally once daily for approximately 26 weeks in pediatric patients aged 10 to 17 years with bipolar disorder. 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate whether lumateperone administered orally once daily for approximately 26 weeks improves or maintains improvement of symptoms based on:
Change from baseline in Childrens Depression Rating Scale Revised (CDRS-R) total score
Change from baseline in Young Mania Rating Scale (YMRS) total score. 		 The safety parameters will include AEs clinical laboratory vital sign ECGs EPS assessments (AIMS BARS & SAS) & C-SSRS. 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="29" 
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)   30/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/02/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="2"
Days="0" 
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  

Multicenter, global, 26-week, open-label (OL) study to assess the safety and tolerability of lumateperone in pediatric patients with bipolar disorder.

The study in India will enroll pediatric patients with the following primary psychiatric diagnosis:

• Bipolar Disorder (aged 10 to 17 years)

• Patients must have completed the bipolar depression lead-in efficacy study (Study ITI-007-421)

• Patients will enroll directly from Study ITI-007-421: Visit 8 of the lead-in study will serve as the Baseline Visit (Visit 2) of this long-term safety study.

This study will be conducted as follows:

• A 26-week Open-label Treatment Period (OLTP) during which all patients will receive lumateperone once daily.

• A 2-week Safety Follow-up (SFU) Period: All patients should return to the clinic for the SFU Visit (Visit 14) approximately 2 weeks after the last dose of lumateperone. 
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