Efficacy and Safety of Paliperidone in Schizophrenia - Bangladesh Study

NCT07153835 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: IRB/USBMC/2025/001
• Study Type: interventional
• Target: 505
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Paliperidone; Extended-Release Paliperidone; Second-Generation Antipsychotics; PANSS; GASS; WHOQOL-BREF; Quasi-Experimental Study; Efficacy; Safety

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 6, Week 12

Secondary Outcomes (2)

• Assessment of Side Effects Using GASS Score

  Baseline, Week 6, and Week 12

• Changes in Quality of Life Measured by WHOQOL-BREF

  Baseline and Week 12

Other Outcomes (2)

• Changes in Laboratory Parameters and ECG

  Baseline and Week 12

• Change in Body Mass Index (BMI)

  Baseline, Week 6, and Week 12

Study Arms (1)

Paliperidone Extended-Release Treatment Arm

EXPERIMENTAL

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.

Drug: Paliperidone extended-release (ER)

Interventions

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.

Paliperidone Extended-Release Treatment Arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sher-E-Bangla Medical College: lead
• ACI Pharmaceuticals: collaborator
• US-Bangla Medical College Hospital: collaborator
• Dr. M M Jalal Uddin: collaborator
• Dr.Ahsan Aziz Sarkar: collaborator

Study Sites (1)

Sher-E-Bangla Medical College Hospital

Barishal, 8200, Bangladesh

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Dr. M M Jalal Uddin Co-invetigator, MBBS,FCPS (Psychiatry), MPH

  National Institute of Neurosciences and Hospital

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

+8801818222228; sum.tariq@gmail.com

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

CONTACT

+8802588846231; ahsan.psychiatry@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a single-arm, open-level, multicenter, prospective, quasi-experimental study

Study Record Dates

• First Submitted: August 16, 2025
• First Posted: September 4, 2025
• Study Start: September 1, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)