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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
505
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.
Sher-E-Bangla Medical College Hospital
Barishal, Bangladesh
Change in PANSS total score from baseline to 12 weeks
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.
Time frame: Baseline, Week 6, Week 12
Assessment of Side Effects Using GASS Score
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.
Time frame: Baseline, Week 6, and Week 12
Changes in Quality of Life Measured by WHOQOL-BREF
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.
Time frame: Baseline and Week 12
Mohammad Tariqul Alam Principal Investigator, MBBS, FCPS (Psychiatry)
CONTACT
Dr. Ahsan Aziz Sarkar Co-investigator, MBBS, FCPS (Psychiatry)
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.