Tests paliperidone extended-release in adults with schizophrenia in Bangladesh
Tests an extended-release form of paliperidone in adults with schizophrenia.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Paliperidone in Schizophrenia - Bangladesh Study
Key facts
- Where
- Barishal, BangladeshSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT07153835, who can take part
Where in Bangladesh
- Sher-E-Bangla Medical College HospitalBarishal, BangladeshNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sher-E-Bangla Medical College
- Trial code
- NCT07153835
- Record updated
- 4 September 2025
- Original description
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.Read full original descriptionShow less
Evaluation of Efficacy and Safety of Paliperidone Among People With Schizophrenia in Bangladesh
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.
Inclusion: 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: Previous known hypersensitivity to paliperidone or risperidone; Current diagnosis of substance related disorder or substance misuse in the previous month; History of being diagnosed with treatment-resistant schizophrenia; Comorbid severe medical or neurological conditions; Pregnant or lactating women; Use of long-acting injectable antipsychotics within the last 3 months.