A clinical trial to study the effects of Brexpiprazole in comparison to Aripiprazole in patients suffering from Acute Schizophrenia

Phase 3

Conditions: Health Condition 1: F209- Schizophrenia, unspecified

Registration Number: CTRI/2024/06/069258

Lead Sponsor: Torrent Pharmaceuticals Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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.

Exclusion Criteria

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.