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NCT Number: NCT07153835

Efficacy and Safety of Paliperidone in Schizophrenia - Bangladesh Study

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sher-E-Bangla Medical College Hospital

Barishal, 8200, Bangladesh

Location contact

Mohammad Tariqul Alam Principal Investigator, FCPS

CONTACT

[email protected]

+8801818222228

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paliperidone extended-release (ER)

Drug

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.

Primary outcomes

  1. Change in PANSS total score from baseline to 12 weeks

    Time frame: 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 outcomes

  1. Assessment of Side Effects Using GASS Score

    Time frame: 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.

  2. Changes in Quality of Life Measured by WHOQOL-BREF

    Time frame: 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.

Other outcomes

  1. Changes in Laboratory Parameters and ECG

    Time frame: Baseline and Week 12

    Safety will be assessed through laboratory investigations including complete blood count, liver and renal function tests, fasting glucose, and lipid profile, as well as 12-lead ECG. Abnormal values or clinically significant changes from baseline will be recorded.

  2. Change in Body Mass Index (BMI)

    Time frame: Baseline, Week 6, and Week 12

    BMI will be calculated as weight (kg) divided by height squared (m²). Height will be measured once at Baseline (without shoes, using a stadiometer) and used for all BMI calculations. Weight will be measured at each visit on a calibrated digital scale with participants in light clothing and no shoes. The reported outcome will be BMI (kg/m²) at each time point and the change from Baseline. Weight and height are collected only to compute BMI and will not be reported as separate outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Ahsan Aziz Sarkar Co-investigator, MBBS, FCPS (Psychiatry)

CONTACT

[email protected]

+8802588846231

Mohammad Tariqul Alam Principal Investigator, MBBS, FCPS (Psychiatry)

CONTACT

[email protected]

+8801818222228

Sponsors and collaborators

Lead sponsor

Sher-E-Bangla Medical College

Other

Collaborators

  • ACI Pharmaceuticals
  • Dr. M M Jalal Uddin
  • Dr.Ahsan Aziz Sarkar
  • US-Bangla Medical College Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 4, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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