Efficacy and Safety of Paliperidone in Schizophrenia - Bangladesh Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Paliperidone extended-release (ER).
- Who it may be relevant to
- Registry conditions: Schizophrenia. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Bangladesh
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Efficacy and Safety of Paliperidone Among People With Schizophrenia in Bangladesh
Overview
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.
Interventions
- Drug Paliperidone extended-release (ER)
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 outcome measures
- Change in PANSS total score from baseline to 12 weeks [Time frame: Baseline, Week 6, Week 12]
Secondary outcome measures (2)
- Assessment of Side Effects Using GASS Score [Time frame: Baseline, Week 6, and Week 12]
- Changes in Quality of Life Measured by WHOQOL-BREF [Time frame: Baseline and Week 12]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Bangladesh · 1 center
- Sher-E-Bangla Medical College Hospital — Barishal
Identifiers
NCT: NCT07153835 · IRB/USBMC/2025/001