Efficacy and Safety of Paliperidone in Schizophrenia - Bangladesh Study

Not Applicable

Not yet recruiting

• Conditions: Schizophrenia
• Interventions: Drug: Paliperidone extended-release (ER)

• Registration Number: NCT07153835
• Lead Sponsor: Sher-E-Bangla Medical College

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 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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-16
• Study First Submitted QC: 2025-08-30
• Last Update Submitted: 2025-08-30
• Study Start: 2025-09-01
• Study First Posted: 2025-09-04
• Last Update Posted: 2025-09-04
• Primary Completion: 2026-03-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 505

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paliperidone Extended-Release Treatment Arm	Paliperidone extended-release (ER)	Participants in this arm will receive paliperidone extended-release (ER) tablets at a flexible daily dose of 6-12 mg, as determined by the treating psychiatrist based on clinical judgment. The treatment will continue for 12 weeks, with clinical assessments at baseline, 6 weeks, and 12 weeks to evaluate efficacy, safety, and quality of life.

Primary Outcome Measures

Name	Time	Method
Change in PANSS total score from baseline to 12 weeks	Baseline, Week 6, Week 12	The Positive and Negative Syndrome Scale (PANSS) will be used to assess the severity of schizophrenia symptoms. The total score ranges from 30 to 210, with higher scores indicating more severe symptoms. The primary outcome is the change in total PANSS score from baseline to week 12 following treatment with paliperidone extended-release.

Secondary Outcome Measures

Name	Time	Method
Assessment of Side Effects Using GASS Score	Baseline, Week 6, and Week 12	The Glasgow Antipsychotic Side-Effect Scale (GASS) will be used to assess self-reported side effects of paliperidone. For participants who are not literate or have difficulty completing the form independently, a trained psychiatrist will administer the scale in an interview format.
Changes in Quality of Life Measured by WHOQOL-BREF	Baseline and Week 12	The WHO Quality of Life-BREF (WHOQOL-BREF) will be used to assess quality of life across four domains: physical health, psychological health, social relationships, and environment. For participants who are not literate, the questionnaire will be administered by a trained psychiatrist through structured interviews.

Trial Locations

Locations (1)

Sher-E-Bangla Medical College Hospital; 🇧🇩 Barishal, Bangladesh