CTRI/2024/06/069258 [Registered on: 20/06/2024] Trial Registered Prospectively
Last Modified On:
21/09/2024
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug Other (Specify) [Randomized,Multi-Centric,Double-blind,Double Dummy,Active Controlled,Parallel Group,Clinical Study]
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A clinical trial to study the effects of Brexpiprazole in comparison to Aripiprazole in patients suffering from Acute Schizophrenia
Scientific Title of Study
A Phase 3, Randomized, Multi-Centric, Double-blind, Double Dummy, Active Controlled, Parallel Group, Clinical Study to Assess the Efficacy and Safety of Brexpiprazole in Comparison to Aripiprazole in Patients Suffering From Acute Schizophrenia
Clinical Research Department, second floor, Torrent Research Centre,
Torrent Pharmaceuticals Limited
Gandhinagar Gujarat NA Gandhinagar GUJARAT 382428 India
Phone
917971315197
Fax
Email
SPrajapati@torrentpharma.com
Details of Contact Person Public Query
Name
Dr Anookh M
Designation
GM-Clinical Operation Team
Affiliation
Torrent Research Centre
Address
Torrent Pharmaceuticals Limited Torrent Research Centre
Clinical Operation Department
Gandhinagar Gujarat NA Gandhinagar GUJARAT 382428 India
Clinical Research Room, Basement, Aatman Hospital, 5, Anveshan Row House, Opp Umiya Mata Mandir, Bopal-Ghuma Main Road, Bopal Ahmedabad, Ahmedabad, Gujarat-380058, India Ahmadabad GUJARAT
9409009484
drfenil.cr@gmail.com
Dr P N Sureshkumar
Chethana Centre for Neuropsychiatric Rehabilitation,
Door No. 12/417-D, Chethana Centre for Neuropsychiatric Rehabilitation, Providence College Road, Malaparamba, Kozhikode, Kerala - 673009, India Kozhikode KERALA
9447218825
drpnsuresh@gmail.com
DrVenu Gopal Jhanwar
Deva Institute of Healthcare & Research
Department of Psychiatry, First Floor, Deva Institute of Healthcare & Research Pvt Ltd, B 27/70 MN, Durgakund, Varanasi, Uttar Pardesh-221005 Varanasi UTTAR PRADESH
9935571052
vgj.dihr@gmail.com
Dr Mahesh Bhirud
Dhadiwal Hospital
Ground floor, OPD 2, Dhadiwal Hospital in coalition with shreeji healthcare, Opp. new CBS, Thakkers Bazar trimbak road, Nashik, Maharastra-422002 Nashik MAHARASHTRA
9890740104
drmgbhirud@gmail.com
DrPradhyuman Chaudhary
GMERS medical college
Room No-4, 101-psychiatry department, A-block, OPD Bhuilding, GMERS Medical College and Hospital, Sola Highway, Near Gujarat High court, Ahmedabad, Gujarat-380061 India Ahmadabad GUJARAT
9825411772
drpradhyuman@gmail.com
DrDhananjay Chaudhari
GSVM
HOD Room, Ground Floor, Department of Psychiatry, G.S.V.M.Medical College, Swaroop Nagar, Kanpur, Uttar Pardesh-208002, India Kanpur Dehat UTTAR PRADESH
9336049009
georgiandc@gmail.com
Dr Bakul Chandrakant Buch
Hatkesh Healthcare Foundation
Saraswasti Mandir Complex Near Bhutnath Temple, College road, Junagadh-362001, Gujarat, India. Junagadh GUJARAT
9825220330 9825220330 bakulbuch@gmail.com
Dr Amrit Pattojoshi
Hi-Tech Medical College & Hospital,
Dept. of Psychiatry, Ground Floor, OPD Building, Hi-Tech Medical College and Hospital, Health Park Pandara, Rasulgarh, Bhubaneswar, Khordha, Orissa - 751025 Khordha ORISSA
Research Room, 1st floor, Building B, Matis Multi-Speciality Hospital, Opposite to Adani CNG Gas Station, Near Motera BRTS Bus Stop,Cross Roads, Motera, Ahmedabad, Gujarat 380005 Ahmadabad GUJARAT
9824012867
drashishcontractor.cr@gmail.com
Dr Gopalakrishnan Ganesan
Medstar speciality hospital
OPD No. 1, Ground Floor, Medstar speciality hospital, #641/17/1/3, Kodigehalli Main Rd, Sahakar Nagar, Bangalore, Karnataka-560092, India Bangalore KARNATAKA
9443165625
drgopalakrishnan.medstar@gmail.com
DrTarak Shah
MITR Foundation
Clinical Research Room, Basement, Aatman Hospital, 5, Anveshan Row House, Opp Umiya Mata Mandir, Bopal-Ghuma Main Road, Bopal Ahmedabad, Ahmedabad, Gujarat-380058, India Ahmadabad GUJARAT
7927551755
tarak_mitr@yahoo.co.in
Dr Asish Mukhopadhyay
NRS Medical College and Hospital
3rd Floor, OPD Building, Dept. of Psychiatry, NRS Medical College and Hospital, 138 Acharya Jagdish Chandra Bose Road, Kolkata, West Bengal-700014 Kolkata WEST BENGAL
8250637511
asish47@gmail.com
Dr Mithun Dutta
Om Multispecialty Hospital
OPD area, Ground floor, Om Multispecialty Hospital, Near H P Petrol Pump, Mahadev Ghat Road, Raipura Chowk, Raipur, Chhattisgarh-492001, India Raipur CHHATTISGARH
10 mg/15 mg / 20 mg / 30 mg / Placebo of Aripiprazole Table once a day along with respective placebo of Brexpiprazole tablet
Intervention
Brexpiprazole Tablet
1 mg/2 mg/3 mg/4 mg/Placebo of Brexpiprazole Tablet once a day along with respective placebo of Aripiprazole tablet. total duration is 42 days.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Patient or patient’s legally acceptable representative willing to give written informed consent to participate in the study.
2. Male or female patients of 18-65 years of age, both inclusive.
3. Patients meeting the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for schizophrenia.
4. Patients newly diagnosed with acute schizophrenia or acute relapse of schizophrenia episodes.
5. Patients with a PANSS total score ≥ 70 at the time of screening.
6. Patients with a CGI-S score ≥ 4 at the time of screening.
7. Patient with relapse, who had received previous outpatient antipsychotic treatment at an adequate dose for the treatment of schizophrenia for an adequate duration and who showed a previous good response to such antipsychotic treatment (other than clozapine) in the 12 months prior to screening, according to the investigator’s opinion.
ExclusionCriteria
Details
1. Patients with a history of hypersensitivity to the study drugs or any of its excipients.
2. Patients with a history of being resistant/refractory to antipsychotic treatment. Patients with a history of failure to respond to clozapine or respond to clozapine treatment only.
3. Patients already hospitalized or who required hospitalization for the treatment of a current episode of schizophrenia as per the investigator’s opinion.
4. Patients who had received electroconvulsive therapy in the past for treatment of schizophrenia episodes.
5. Elderly patients with dementia-related psychosis.
6. Patients with a diagnosis of mental retardation or other cognitive disorder, any other Axis I psychiatric diagnosis.
7. Patients currently receiving antipsychotic drug therapy.
8. Patients considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
9. Clinically significant suicidal or homicidal behavior or attempts within the past 6 months.
10. Patients who received clozapine for any reason other than schizophrenia within the last 4 months of randomization.
11. Patients who received treatment with mood stabilizers or antidepressants within 1 week, fluoxetine hydrochloride at any time within 1 month, or a monoamine oxidase (MAO) inhibitor within 3 weeks prior to screening.
12. Patients with a history of Neuroleptic Malignant Syndrome (NMS).
13. Patients with a history of pituitary adenoma.
14. Patients who have received or are currently receiving depot neuroleptics.
15. Patients with a surgical or medical condition that, in the judgment of the Investigator, could interfere with the absorption, distribution, metabolism, or excretion of the study drugs.
16. Patients with a history of alcohol and/or drug abuse within the past 12 months.
17. Patients with liver enzymes (alanine transaminase, aspartate transaminase, alkaline phosphatase) 2.5X the upper limit of normal value (ULN) or total bilirubin 1.5X of ULN or serum creatinine ULN and considered clinically significant by Investigator.
18. Patient with a history of HIV and/or HBV and/or HCV.
19. Patients who have participated in any other investigational drug trial within the past 3 months prior to screening.
20. Patients who are on Insulin for the management of diabetes.
21. Patients who are on antidiabetic medications other than Insulin and still found HBA1C more than 7% at screening.
22. Patients with a history of ischemic heart disease or history of myocardial infarction, congestive heart failure (whether controlled or uncontrolled), angioplasty, stenting, or coronary artery bypass surgery.
23. Pregnant or lactating women or females of childbearing potential, who are neither surgically sterilized nor willing to use reliable contraceptive methods throughout the study duration or male subjects of childbearing potential not willing to use reliable contraception methods throughout the study duration.
24. Patients, in the opinion of the Investigator, are either unable to cooperate or unlikely to adhere to any study procedures.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome
Outcome
TimePoints
Mean change from baseline in positive and negative syndrome scale. PANSS
 Week 6
Secondary Outcome
Outcome
TimePoints
The proportion of Subjects who experienced adverse events(AEs)
Week 6
Target Sample Size
Total Sample Size="304" Sample Size from India="304" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This will be a randomized, multi-centric, double-blind, double-dummy, active controlled parallel-group clinical trial. The study will compare efficacy and safety of brexpiprazole with aripiprazole in patients with acute schizophrenia episode. A total of 304 patients with acute schizophrenia episode will be randomized. Patients will be enrolled in a ratio of 1:1 to receive either brexpiprazole tablet (test arm) or aripiprazole tablet (control arm).