CTRI/2025/11/097252 [Registered on: 11/11/2025] Trial Registered Prospectively
Last Modified On:
03/11/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A study to compare the effects of Brexpiprazole and Aripiprazole tablets in adults with schizophrenia.
Scientific Title of Study
A Multicentric, Prospective, Parallel Group, Randomized, Double Blind, Double Dummy, Active Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Brexpiprazole Tablets in Comparison with Aripiprazole Tablets in Adult Patients for the Treatment of Acute Schizophrenia.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
CT/2025/03, Version No.: 00 and Dated Jan 28, 2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Rajasekhara Reddy Tamma
Designation
Managing Director
Affiliation
Clinwave Research Pvt. Ltd.
Address
Clinwave Research Pvt. Ltd.,
LIG: B by 466, H. No.: 1-16-10 by 466,
Dr. A.S. Rao Nagar, Kapra, Medchal-Malkajgiri (Dist.).
Hyderabad TELANGANA 500062 India
Phone
7989233379
Fax
Email
dr.sekhar@clinwave.co.in
Details of Contact Person Scientific Query
Name
Dr Rajasekhara Reddy Tamma
Designation
Managing Director
Affiliation
Clinwave Research Pvt. Ltd.
Address
Clinwave Research Pvt. Ltd.,
LIG: B by 466, H. No.: 1-16-10 by 466,
Dr. A.S. Rao Nagar, Kapra, Medchal-Malkajgiri (Dist.).
TELANGANA 500062 India
Phone
7989233379
Fax
Email
dr.sekhar@clinwave.co.in
Details of Contact Person Public Query
Name
Mr Mihir Upadhyay
Designation
Sr. Manager - Regulatory Affairs
Affiliation
Exemed Pharmaceuticals
Address
Exemed Pharmaceuticals,
Plot No. 133 by 1 and 133 by 2, GIDC, Selvas Road, Vapi.
Valsad GUJARAT 396195 India
Phone
7405490368
Fax
Email
mihir.upadhyay@exemedpharma.com
Source of Monetary or Material Support
Exemed Pharmaceuticals,
Plot No. 133 by 1 and 133 by 2, GIDC,
Selvas Road, Vapi-396195, Gujarat, India.
Primary Sponsor
Name
Exemed Pharmaceuticals
Address
Plot No. 133 by 1 and 133 by 2, GIDC,
Selvas Road, Vapi-396195, Gujarat, India.
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 9
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Varsha Shyam Dawani
Ashirwad Hospital and Research Centre
Research Room, Maratha Section, Near Jijamata Udyan, Ulhasnagar, Thane-421004.
Thane MAHARASHTRA
7499109168
varshadawani@yahoo.com
Dr Shrirang Dharmaji Solunke
Baramati Hospital
Research Room, Behind Kavivarya Moropant Natyamandir, Ring Road, Baramati, Pune-413102. Pune MAHARASHTRA
9890734888
drsolunke.baramati12@gmail.com
Dr KVM Sai Lahari
Great Eastern Medical School and Hospital
Research Room, Ragolu, Srikakulam-532484. Srikakulam ANDHRA PRADESH
8019714709
drsailahariresearch@gmail.com
Dr M Meena Kumari
Latha Super Specialities Hospital
Research Room, D. No.: 29-14-58, Prakasam Road, Suryaraopet, Vijayawada-520002. Krishna ANDHRA PRADESH
9985464003
meenamedikonda@gmail.com
Dr YSS Ramalingeswara Rao
Mahatma Gandhi Memorial Hospital
Department of Psychiatry, Sherpura, Warangal-506002. Warangal TELANGANA
9885820820
drsrinivasa.krcwgl@gmail.com
Dr Vivek Kumar
NSCB Subharti Medical College and Hospital
Department of Psychiatry,
Subharti Puram, NH-58, Delhi-Haridwar Bypass Road, Meerut-250005.
Meerut UTTAR PRADESH
9717070180
Vivekk_20@yahoo.com
Dr Ajaya Mishra
Srirama Chandra Bhanja Medical College and Hospital
Department of Psychiatry,
CK 7 Medical College, Cuttack-753007.
Cuttack ORISSA
9437277703
dr.ajayamishra@yahoo.co.in
Dr Amit Bhalchandra Yeole
Supe Heart & Diabetes Hospital and Research Centre
Research Room, Opp. Adhar Ashram, Near Rungtha School, Gharpure Ghat Road, Nasik-422002.
Nashik MAHARASHTRA
Aripiprazole Tablets 10 mg / 15 mg / 20 mg / 30 mg once a day along with respective placebo of Brexpiprazole Tablets 1 mg / 2 mg / 3 mg / 4 mg. Total treatment duration is 42 days.
Intervention
Brexpiprazole Tablets 1 mg / 2 mg / 3 mg / 4 mg
Brexpiprazole Tablets 1 mg / 2 mg / 3 mg / 4 mg once a day along with respective placebo of Aripiprazole Tablets 10 mg / 15 mg / 20 mg / 30 mg. Total treatment duration is 42 days.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Male and female patients aged between 18 to 65 years (both inclusive).
2. Patients with documented diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria.
3. Patients with newly diagnosed acute schizophrenia or acute relapse of schizophrenia episodes.
4. Patients with a Positive and Negative Syndrome Scale (PANSS) total score greater than or equal to 70 at screening visit.
5. Patients with a Clinical Global Impressions – Severity (CGI-S) score greater than or equal to 4 at screening visit.
6. Patients 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.
7. Women of childbearing potential must have a negative urine pregnancy test prior to study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till end of the study visit.
8. Patient with ability to understand and provide written, signed and dated informed consent form which must have been obtained prior to screening.
9. Patients are willing and able to comply with all the protocol requirements.
ExclusionCriteria
Details
1. Patients with intolerance, contraindication or potential allergy or hypersensitivity to study drug or drugs of similar chemical class.
2. Patients with a medical history of resistant or refractory to antipsychotic treatment. Patients with a medical history of failure to respond to Clozapine or respond to Clozapine treatment only.
3. Patients who are already hospitalized or who required hospitalization for the treatment of a current episode of schizophrenia as per the investigator’s opinion.
4. Patients with a history of electroconvulsive therapy (ECT) for the treatment of schizophrenia episodes.
5. Patients diagnosed with dementia-related psychosis.
6. Patients with a diagnosis of mental retardation or other cognitive disorder, any other Axis I psychiatric diagnosis.
7. Patients who are currently receiving antipsychotic drug therapy.
8. Patients deemed by the investigator to be at imminent risk of suicide or self-harm, harm to others or property damage.
9. Patients with a history of 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 prior to 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 medical history of Neuroleptic Malignant Syndrome (NMS).
13. Patients with documented evidence of severe tardive dyskinesia, severe dystonia or any other severe movement disorder.
14. Patients with a medical history of pituitary adenoma or hyperprolactinemia (prolactin concentration greater than 100 ng by mL at screening).
15. Patients who have received or are currently receiving depot neuroleptics.
16. Patients with clinically significant impaired hepatic function (i.e., AST, ALT and ALP more than 2.5X the ULN and or Total bilirubin more than 1.5X the ULN) at screening visit.
17. Patients with serum creatinine levels greater than or equal to 2 mg by dL at screening visit.
18. Patients who require Insulin therapy for the management of diabetes.
19. Patients with type 2 diabetes mellitus whose diabetes has not been stable and controlled for the previous three months and with HbA1c value greater than or equal to 7%.
20. Patients with uncontrolled thyroid disease and or abnormal free thyroxine (FT4) examination results at screening, unless it has been confirmed by the investigator that the condition has been stabilized by medication greater than 90 days before screening.
21. Patients with known cases of infection with hepatitis B, hepatitis C or HIV.
22. Female patients who are pregnant or lactating or planning to become pregnant during the study period.
23. Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier methods or intrauterine device).
24. Patients with significant cardiovascular history defined as: myocardial infarction, congestive heart failure (whether controlled or uncontrolled), unstable angina pectoris, transient ischemic attack, unstable or previously undiagnosed arrhythmia, cardiac surgery or revascularization (coronary angioplasty or bypass grafts), or cerebrovascular accident.
25. Patients with clinically significant neurological, metabolic, hepatic, renal, hematological, pulmonary, gastrointestinal and/or urological disorder.
26. Patients who require treatment with strong CYP3A4 inhibitors (e.g., Ketoconazole) or strong CYP3A4 inducers (e.g., Rifampin) during the study.
27. Patients with any abnormality on 12-lead ECG [QTc greater than or equal to 450 msec (for males) or greater than or equal to 470 msec (for females)] at screening that in the opinion of the investigator is clinically significant and is judged as potential risk for patient’s participation in the study.
28. Patients with a history of substance abuse or dependence that in the opinion of the Investigator is considered to interfere with the patient’s participation in the study.
29. Patients with concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent.
30. Patients currently taking any of the prohibited medications(s) and inability or unwillingness to discontinue them for the entire study period.
31. Patients with suspected inability or unwillingness to comply with the study procedures.
32. Patient with any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pre-numbered or coded identical Containers
Blinding/Masking
Double Blind Double Dummy
Primary Outcome
Outcome
TimePoints
Mean change in positive and negative syndrome scale (PANSS) total score from baseline to end of the treatment visit i.e., week 6.
Visit 2 - Baseline or Randomization visit (Day 1) and
Visit 7 - End of the treatment visit / Week 6 (Day 43±2).
Secondary Outcome
Outcome
TimePoints
Mean change in positive and negative syndrome scale (PANSS) total score from baseline to week 1, week 2, week 3 and week 4.
Visit 2 - Baseline or Randomization visit (Day 1),
Visit 3 - Follow up visit / Week 1 (Day 8±1),
Visit 4 - Follow up visit / Week 2 (Day 15±1),
Visit 5 - Follow up visit / Week 3 (Day 22±1) and
Visit 6 - Follow up visit / Week 4 (Day 29±1).
Proportion of responders in positive and negative syndrome scale (PANSS) at week 1, week 2, week 3, week 4 and week 6.
Visit 3 - Follow up visit / Week 1 (Day 8±1),
Visit 4 - Follow up visit / Week 2 (Day 15±1),
Visit 5 - Follow up visit / Week 3 (Day 22±1),
Visit 6 - Follow up visit / Week 4 (Day 29±1) and
Visit 7 - End of the treatment visit / Week 6 (Day 43±2).
Change in clinical global impression - severity (CGI-S) from baseline to week 1, week 2, week 3, week 4 and week 6.
Visit 3 - Follow up visit / Week 1 (Day 8±1),
Visit 4 - Follow up visit / Week 2 (Day 15±1),
Visit 5 - Follow up visit / Week 3 (Day 22±1),
Visit 6 - Follow up visit / Week 4 (Day 29±1) and
Visit 7 - End of the treatment visit / Week 6 (Day 43±2).
Change in clinical global impression - improvement (CGI-I) from baseline to week 1, week 2, week 3, week 4 and week 6.
Visit 3 - Follow up visit / Week 1 (Day 8±1),
Visit 4 - Follow up visit / Week 2 (Day 15±1),
Visit 5 - Follow up visit / Week 3 (Day 22±1),
Visit 6 - Follow up visit / Week 4 (Day 29±1) and
Visit 7 - End of the treatment visit / Week 6 (Day 43±2).
Mean change in positive and negative syndrome scale (PANSS) positive subscale score from baseline to week 1, week 2, week 3, week 4 and week 6.
Visit 3 - Follow up visit / Week 1 (Day 8±1),
Visit 4 - Follow up visit / Week 2 (Day 15±1),
Visit 5 - Follow up visit / Week 3 (Day 22±1),
Visit 6 - Follow up visit / Week 4 (Day 29±1) and
Visit 7 - End of the treatment visit / Week 6 (Day 43±2).
Mean change in positive and negative syndrome scale (PANSS) negative subscale score from baseline to week 1, week 2, week 3, week 4 and week 6.
Visit 3 - Follow up visit / Week 1 (Day 8±1),
Visit 4 - Follow up visit / Week 2 (Day 15±1),
Visit 5 - Follow up visit / Week 3 (Day 22±1),
Visit 6 - Follow up visit / Week 4 (Day 29±1) and
Visit 7 - End of the treatment visit / Week 6 (Day 43±2).
Adverse events and serious adverse events reported during the study.
Throughout the study.
Changes in clinical laboratory parameters from screening to end of the treatment visit (Week 6).
Visit 1 - Screening visit (up to -2 weeks) and
Visit 7 - End of the treatment visit / Week 6 (Day 43±2).
Target Sample Size
Total Sample Size="220" Sample Size from India="220" 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)
01/12/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
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
Patients with documented diagnosis of schizophrenia according to
Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)
criteria, newly diagnosed acute schizophrenia or acute relapse of schizophrenia
episodes prior to screening will be screened (visit 1) within 2 weeks prior to
their randomization. The eligible patients will then be randomized to either of
the 2 study groups as per their randomization number on randomization visit
(visit 2, day 1). After randomization, patients will then be followed up on an
outpatient basis with scheduled visits at week 1 (visit 3), week 2 (visit 4),
week 3 (visit 5), week 4 (visit 6), week 6 (visit 7 - end of the treatment
visit) and week 7 (visit 8 - end of the study. This will be a parallel group
study and all the enrolled patients will be instructed to take the study drugs as
per the prescribed regimen for a treatment period of 6 weeks.