NCT07153835Not yet recruitingPhase 4
Efficacy and Safety of Paliperidone in Schizophrenia - Bangladesh Study
Evaluation of Efficacy and Safety of Paliperidone Among People With Schizophrenia in Bangladesh
Source: ClinicalTrials.gov · Last updated 4 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 505 (estimated)
- First submitted
- 16 Aug 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 31 Mar 2026
- Lead sponsor
- Sher-E-Bangla Medical College
- Diseases
- Schizophrenia
- NCT number
- NCT07153835
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 505
- From 1 Sept 2025 to the primary completion date, 31 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous known hypersensitivity to paliperidone or risperidone
- Current diagnosis of substance related disorder or substance misuse in the previous month
Other illness
- History of being diagnosed with treatment-resistant schizophrenia
- Comorbid severe medical or neurological conditions
Other
- Pregnant or lactating women
- Use of long-acting injectable antipsychotics within the last 3 months
Who the study is looking for
- 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
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sher-E-Bangla Medical College Hospital Coordinator of this site? Confirm its status | Barishal | Bangladesh | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.