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NOT YET RECRUITING
NCT07153835
PHASE4

Efficacy and Safety of Paliperidone in Schizophrenia - Bangladesh Study

Sponsor: Sher-E-Bangla Medical College

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

505

Start Date

2025-09-01

Completion Date

2026-07-31

Last Updated

2025-09-04

Healthy Volunteers

No

Conditions

Interventions

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.

Locations (1)

Sher-E-Bangla Medical College Hospital

Barishal, Bangladesh