Status:
NOT_YET_RECRUITING
Efficacy and Safety of Paliperidone in Schizophrenia - Bangladesh Study
Lead Sponsor:
Sher-E-Bangla Medical College
Collaborating Sponsors:
ACI Pharmaceuticals
US-Bangla Medical College Hospital
Conditions:
Schizophrenia
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
This is a single-arm, open-label, multicenter, prospective quasi-experimental study evaluating the efficacy and safety of extended-release paliperidone in adults with schizophrenia in Bangladesh. The ...
Detailed Description
Despite global evidence supporting the effectiveness of paliperidone, there is limited data from low- and middle-income countries such as Bangladesh. This study addresses this evidence gap by assessin...
Eligibility Criteria
Inclusion
- Adults aged 18-60 years
- Diagnosed with schizophrenia according to DSM-5 criteria
- At least 3 months since the initial diagnosis of schizophrenia
- Either antipsychotic-naïve or previously treated with one antipsychotic but requiring a change due to non-response, poor response, or intolerable side effects. (If previously treated, a washout period of 7 days before study medication initiation)
- PANSS (Positive and Negative Syndrome Scale) total score ≥70
- Clinically stable for at least 2 weeks before enrollment
Exclusion
- History of being diagnosed with treatment-resistant schizophrenia
- Comorbid severe medical or neurological conditions
- Pregnant or lactating women
- Previous known hypersensitivity to paliperidone or risperidone
- Use of long-acting injectable antipsychotics within the last 3 months
- Current diagnosis of substance related disorder or substance misuse in the previous month
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
505 Patients enrolled
Trial Details
Trial ID
NCT07153835
Start Date
September 1 2025
End Date
July 31 2026
Last Update
September 4 2025
Active Locations (1)
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1
Sher-E-Bangla Medical College Hospital
Barishal, Bangladesh, 8200