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Efficacy and Safety of Paliperidone in Schizophrenia - Bangladesh Study

NCT07153835 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 505

Last updated 2025-09-04

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • ACI Pharmaceuticals

    collaborator UNKNOWN

  • US-Bangla Medical College Hospital

    collaborator UNKNOWN

  • Dr. M M Jalal Uddin

    collaborator UNKNOWN

  • Dr.Ahsan Aziz Sarkar

    collaborator UNKNOWN

  • Sher-E-Bangla Medical College

    lead OTHER

Principal Investigators

  • Dr. M M Jalal Uddin Co-invetigator, MBBS,FCPS (Psychiatry), MPH · National Institute of Neurosciences and Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-03-31
Completion
2026-07-31

Countries

  • Bangladesh

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07153835 on ClinicalTrials.gov