NCT07153835

Efficacy and Safety of Paliperidone in Schizophrenia - Bangladesh Study

Evaluation of Efficacy and Safety of Paliperidone Among People With Schizophrenia in Bangladesh

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 505 (estimated)
• Sponsor: Sher-E-Bangla Medical College · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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 study will assess psychotic symptom improvement using the PANSS scale, monitor side effects using GASS, and evaluate quality of life via WHOQOL-BREF.

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 assessing the efficacy and safety of paliperidone ER in a real-world, multi-site setting. The primary endpoint is the change in PANSS score after 12 weeks of treatment. Secondary outcomes include side-effect profile, safety assessments, and quality of life. A total of 505 participants will be enrolled.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Paliperidone extended-release (ER)	Paliperidone extended-release (ER) tablets will be administered orally once daily at flexible doses ranging from 6 mg to 12 mg, based on the clinical judgment of the treating psychiatrist. The treatment duration is 12 weeks. Dose adjustments may be made throughout the study period depending on patient response and tolerability.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-03-31
• Completion: 2026-07-31
• First posted: 2025-09-04
• Last updated: 2025-09-04

Locations

1 site across 1 country: Bangladesh