| CTRI Number |
CTRI/2023/10/059345 [Registered on: 31/10/2023] Trial Registered Prospectively |
| Last Modified On: |
26/06/2026 |
| 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 check out the effectiveness and safety of Lumateperone as another treatment used together with the main treatment in the Treatment of Patients with Major Depressive Disorder |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Lumateperone as as Adjunctive Therapy in the Treatment of Patients with Major Depressive Disorder |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 2023-503836-41-00 |
EudraCT |
| ITI-007-505 Protocol Amendment 4 dated 06 May 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
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| Fax |
|
| Email |
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|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Shweta Pradhan |
| Designation |
Head Clinical Operations |
| Affiliation |
IQVIA RDS (India) Private Limited |
| Address |
IQVIA RDS (India) Private Limited
Omega Embassy Tech Square, Marathahalli - Sarjapura, Outer Ring Road, Kadubeesanahalli,
Bangalore
KARNATAKA
560103
India |
| Phone |
9513774664 |
| Fax |
|
| Email |
shweta.pradhan@iqvia.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Shweta Pradhan |
| Designation |
Head Clinical Operations |
| Affiliation |
IQVIA RDS (India) Private Limited |
| Address |
IQVIA RDS (India) Private Limited
Omega Embassy Tech Square, Marathahalli - Sarjapura, Outer Ring Road, Kadubeesanahalli,
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 |
|
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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 |
|
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Countries of Recruitment
|
Bulgaria
France
India
Lithuania
Serbia
Spain
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 14 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pradeep Patil |
Acharya Vinoba Bhave Rural Hospital |
Datta Meghe Institute of Higher Education & Reserach, JNMC, Sawangi Meghe, Wardha-442004
Wardha
MAHARASHTRA |
8999248979
dr.p.s.patil2012@gmail.com |
| Dr Shrirang Dharmaji Solunke |
Baramati Hospital Pvt Ltd |
Room No.-117, Department-Psychiatrics, Behind Kavivarya Moropant Natyamandir Ring Road, Baramati – 41310
Pune
MAHARASHTRA |
9890734888
drsolunke.baramati12@gmail.com |
| Dr Timirkumar Chandrakant Shah |
Divyam Hospital |
Divyam Institute of Psychiatry
Block No. 84, Palsana Cross Rd, N.H. No. 8, Surat-394315
Surat
GUJARAT |
9825137443
drtcshah@gmail.com |
| Dr Deepanjali Medhi |
Guwahati Medical College and Hospital |
Narakasur Hilltop Hospital Road Bhangagarh, Guwahati - 781032
Kamrup
ASSAM |
9435115263
deepanjali.medhi@yahoo.com |
| Dr Parth Singh Meena |
Jawahar Lal Nehru Medical College |
Kala Bagh, Ajmer-305001
Ajmer
RAJASTHAN |
9414456991
doctor.parth@outlook.com |
| Dr Shrikant Nimbhorkar |
KIMS-Kingsway Hospitals |
SPANV Medisearch Lifesciences Private Limited, 44, Parwana Bhawan, Kingsway, Nagpur-440001
Nagpur
MAHARASHTRA |
8600877750
dr.shrikantnimbhorkar@gmail.com |
| Dr Vijaykumar Nagecha |
Nagecha Hospital |
Creative chamber, Opp. Hotel Ruby, Beside S.T. Bus stand, Kanak Road
Rajkot
GUJARAT |
9824201520
nagecha@gmail.com |
| Dr Alpesh Gediya |
Navneet Memorial Hospital “SUSHRUSHA†|
Opp. Sardar Patel Seva Samaj Hall, In the lane, Opp. Telephone Exchange, Navrangpura, Ahmedabad- 380009
Ahmadabad
GUJARAT |
9909919369
alpeshgediyacr@gmail.com |
| Dr Swapnajeet Sahoo |
Post Graduate Institute of Medical Education and Research |
Sector 12, Chandigarh-160012
Chandigarh
CHANDIGARH |
91 8872727744
swapnajeetsame@gmail.com |
| Dr Anu Kant Mittal |
Rajiv Gandhi Medical College & Chhatrapati Shivaji Maharaj Hospital |
OPD no 21, Physichiarty OPD, Old Thane, Belapur Road Budhaji Nagar, Kalwa West, Thane-400605
Thane
MAHARASHTRA |
9820164327
akmital@gmail.com |
| Dr Vaishal Nareshchandra Vora |
Ratandeep Multispecialty Hospital |
Nakshatra Complex, Above HDFC Bank, Maninagar Crossroads, Maninagar -380008
Ahmadabad
GUJARAT |
9825440891
vnvora@gmail.com |
| Dr Shri Gopal |
S. P. Medical College & A.G. of Hospitals |
S. P. Medical College & A.G. of Hospitals, Bikaner – 334001,
Bikaner
RAJASTHAN |
8947825749
shriigopalgoyal@gmail.com |
| Dr Jadhavar Kishor Vitthal |
Shree Samarth Hospital |
Clinical research Department, 3rd Floor, 227, Clinical research Department, 3rd Floor Omkar Apartment, Rastha Peth-411011
Pune
MAHARASHTRA |
8806199444
drkishorjadhavar@gmail.com |
| Dr Nikhil Chougule |
Swastik Hospital |
Department- Psychiatric,
Room- first floor, Near PI OPD, Clinical Research Room,
142/12/A, E Ward, Assembly Road, Near Mahaveer Garden-416001
Kolhapur
MAHARASHTRA |
9890533993
drnikhil.crd@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 14 |
| Name of Committee |
Approval Status |
| Divyamk Hospital Ethical Review Board |
Approved |
| Ethics Committee of Baramati Hospital Pvt Ltd |
Approved |
| Ethics committee S.P. Medical College, Rajasthan |
Approved |
| IEC, Jawahar Lal Nehru Medical College |
Approved |
| Institutional Clinical Ethics Committee RGMC & Chhatrapati Shivaji Maharaj Hospital |
Submittted/Under Review |
| Institutional Ethics Committee Human, Gokul |
Approved |
| Institutional Ethics Committee of DMIHER |
Approved |
| Institutional Ethics Committee, PGIMER |
Approved |
| Institutional Ethics Committee, GMCH |
Approved |
| Institutional Ethics Committee, Shree Samarth Hospital |
Approved |
| Kingsway Hospitals Ethics Committee, Nagpur |
Approved |
| Om Sai Onco Institutional Ethics Committee |
Approved |
| Ratandeep Institutional Ethics Committee |
Approved |
| Sangini Hospital Ethics Committee, Ahmedabad |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F339||Major depressive disorder, recurrent, unspecified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lumateperone or Placebo |
Details:
Route: Oral
Dose: Formulated Capsules (42 mg)
Double-blind Treatment Period (6 weeks) in which all patients will be randomized to receive placebo or lumateperone 42 mg/day in 1:1 ratio |
| Comparator Agent |
Placebo |
Details: Route: Oral Dose: Formulated Capsules (42 mg) Double-blind Treatment Period (6 weeks) in which all patients will be randomized to receive placebo or lumateperone 42 mg/day in 1:1 ratio |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Provides written informed consent
2. Male or female patients between the ages 18 and 65 years, inclusive
3. Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for MDD (MDD with psychotic features will be acceptable) as confirmed by the Investigator or Sponsor approved rater using the modified Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT), and meet all the following criteria:
a. The start of the current MDE is at least 12 weeks but no more than 18 months prior to Screening (Visit 1)
b. Has at least moderate severity of illness based on rater administered MADRS total score ≥ 24 at Screening (Visit 1) and at Baseline (Visit 2)
c. Has at least moderate severity of illness based on CGI-S score ≥ 4 at Screening (Visit 1) and at Baseline (Visit 2)
d. Has a QIDS-SR-16 score ≥ 14 at Screening (Visit 1) and at Baseline (Visit 2)
e. Has sufficient history and medical record confirmation (as defined in the Study Reference Manual) verifying ADT and the current MDE is causing clinically significant distress or impairment in social, occupational, or other important areas of functioning.
4. Currently having an inadequate response (less than 50% improvement) to 2 or more ADTs in the current MDE as confirmed by the Investigator using the ATRQ and taking at least the minimum effective dose (per package insert) of one of the following antidepressants as monotherapy treatment for at least 6 weeks duration and:
a. citalopram/escitalopram
b. fluoxetine
c. paroxetine
d. sertraline
e. duloxetine
f. levomilnacipran/milnacipran (if locally approved for MDD)
g. venlafaxine/desvenlafaxine
h. bupropion
i. vilazodone
j. vortioxetine |
|
| ExclusionCriteria |
| Details |
1. Within the patient’s lifetime, has a confirmed DSM-5 psychiatric diagnosis other than MDD, including:
a. Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder
b. Bipolar disorder
2. Within 6 months of Screening, has a confirmed DSM-5 psychiatric diagnosis other than MDD including:
a. Anxiety disorders such as Panic Disorder or Generalized Anxiety Disorder; Obsessive-compulsive Disorder; Posttraumatic Stress Disorder as primary diagnoses. Note: Anxiety symptoms may be allowed if secondary to MDD,
provided these symptoms do not require concurrent treatment
b. Eating disorder
c. Substance use disorders (excluding nicotine)
d. Personality disorder of sufficient severity to have a major impact on the patient’s psychiatric status;
e. Within 12 months of Screening, has had any other psychiatric condition (other than MDD) that has been the main focus of treatment;
3. The patient experiences a ≥ 25% decrease in the MADRS total score between Screening (Visit 1) and Baseline (Visit 2)
4. The patient experiences a ≥ 25% decrease in the QIDS-SR-16 total score between Screening (Visit 1) and Baseline (Visit 2)
5. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during participation in the study or:
a. At Screening (Visit 1), the patient scores “yes†on Suicidal Ideation Items 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening, or at Baseline (Visit 2), the patient scores “yes†on Suicidal Ideation Items 4 or 5 since the Screening Visit
b. At Screening (Visit 1), the patient has had 1 or more suicide attempts within 2 years prior to Screening
c. At Screening (Visit 1) or Baseline (Visit 2), the patient scores ≥ 5 on MADRS Item 10 (Suicidal Thoughts), or
d. The patient is considered to be in imminent danger to him/herself or others.
6. The patient has a first MDE at age 60 years or older. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Centralized |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of lumateperone 42 mg administered once daily compared with placebo as adjunctive treatment to antidepressant therapy in patients with Major Depressive Disorder (MDD) who have an inadequate response to ongoing antidepressant therapy (ADT) as measured by change from baseline to Day 43 in the Montgomery-Ã…sberg Depression Rating Scale (MADRS) total score |
Day 43 |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of lumateperone 42 mg administered once daily compared with placebo as adjunctive treatment to ADT in patients with MDD who have an inadequate response to ongoing ADT as measured by change from baseline to Day 43 in the Clinical Global Impression Scale-Severity (CGI-S) |
Day 43 |
|
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Target Sample Size
|
Total Sample Size="470"
Sample Size from India="101"
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)
|
31/12/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/05/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="3" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
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 an international, multicenter, randomized, double-blind, placebo controlled, parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an inadequate response to ongoing ADT. The study will be conducted in three periods: Screening Period (up to 2 weeks) during
which patient eligibility will be assessed
Double-blind Treatment Period (6 weeks) in
which all patients will be randomized to receive placebo or lumateperone 42
mg/day in 1:1 ratio. Safety Follow-up Period (1 week) in which all patients will return to the clinic for a safety follow-up visit approximately one week after the last dose of study treatment. |