CTRI/2024/06/069258
Not yet recruiting
Phase 3
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
Torrent Pharmaceuticals Ltd.20 sites in 1 country304 target enrollmentStarted: June 30, 2024Last updated:
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Torrent Pharmaceuticals Ltd.
- Enrollment
- 304
- Locations
- 20
- Primary Endpoint
- Mean change from baseline in positive and negative syndrome scale. PANSS
Overview
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). |
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patient or patient’s legally acceptable representative willing to give written informed consent to participate in the study.
- •Male or female patients of 18-65 years of age, both inclusive.
- •Patients meeting the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for schizophrenia.
- •Patients newly diagnosed with acute schizophrenia or acute relapse of schizophrenia episodes.
- •Patients with a PANSS total score ≥ 70 at the time of screening.
- •Patients with a CGI-S score ≥ 4 at the time of screening.
- •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
- •Patients with a history of hypersensitivity to the study drugs or any of its excipients.
- •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.
- •Patients already hospitalized or who required hospitalization for the treatment of a current episode of schizophrenia as per the investigator’s opinion.
- •Patients who had received electroconvulsive therapy in the past for treatment of schizophrenia episodes.
- •Elderly patients with dementia-related psychosis.
- •Patients with a diagnosis of mental retardation or other cognitive disorder, any other Axis I psychiatric diagnosis.
- •Patients currently receiving antipsychotic drug therapy.
- •Patients considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
- •Clinically significant suicidal or homicidal behavior or attempts within the past 6 months.
Outcomes
Primary Outcomes
Mean change from baseline in positive and negative syndrome scale. PANSS
Time Frame: Â Week 6
Secondary Outcomes
- The proportion of Subjects who experienced adverse events(AEs)(Week 6)
Investigators
Dr Sanjay Maroo
Torrent Research Centre
Study Sites (20)
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