Efficacy and Safety of Paliperidone in Schizophrenia - Bangladesh Study

Sher-E-Bangla Medical College

Status and phase: Not yet enrolling; Phase 4

Conditions: Schizophrenia

Treatments: Drug: Paliperidone extended-release (ER)

Study type: Interventional

Funder types: Other

Identifiers

NCT07153835

IRB/USBMC/2025/001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 505 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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505 participants in 1 patient group

Paliperidone Extended-Release Treatment Arm

Experimental group

Description:

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.

Treatment:

Drug: Paliperidone extended-release (ER)