Health Condition 1: F209- Schizophrenia, unspecified
Conditions
Interventions
Intervention1: 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 /
Sponsors
Exemed Pharmaceuticals
Eligibility
Inclusion criteria
Inclusion criteria: 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 â?? 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 investigatorâ??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.
Exclusion criteria
Exclusion criteria: 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 investigatorâ??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 angio
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Mean change in positive and negative syndrome scale (PANSS) total score from baseline to week 1, week 2, week 3 and week 4.Timepoint: 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.Timepoint: 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.Timepoint: 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.Timepoint: 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.Timepoint: 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 | — |
Primary
| Measure | Time frame |
|---|---|
| Mean change in positive and negative syndrome scale (PANSS) total score from baseline to end of the treatment visit i.e., week 6.Timepoint: Visit 2 - Baseline or Randomization visit (Day 1) and Visit 7 - End of the treatment visit / Week 6 (Day 43±2). | — |
Countries
India
Contacts
Public ContactMr Mihir Upadhyay
Clinwave Research Pvt. Ltd.
Outcome results
None listed