Schizophrenia
Conditions
Keywords
Schizophrenia, Paliperidone, Extended-Release Paliperidone, Second-Generation Antipsychotics, PANSS, GASS, WHOQOL-BREF, Quasi-Experimental Study, Efficacy, Safety
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.
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
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.
Sponsors
ACI Pharmaceuticals
US-Bangla Medical College Hospital
Dr. M M Jalal Uddin
Dr.Ahsan Aziz Sarkar
Sher-E-Bangla Medical College
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a single-arm, open-level, multicenter, prospective, quasi-experimental study
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PANSS total score from baseline to 12 weeks | Baseline, Week 6, Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Side Effects Using GASS Score | Baseline, Week 6, and Week 12 | The Glasgow Antipsychotic Side-Effect Scale (GASS) will be used to assess self-reported side effects of paliperidone. For participants who are not literate or have difficulty completing the form independently, a trained psychiatrist will administer the scale in an interview format. |
| Changes in Quality of Life Measured by WHOQOL-BREF | Baseline and Week 12 | The WHO Quality of Life-BREF (WHOQOL-BREF) will be used to assess quality of life across four domains: physical health, psychological health, social relationships, and environment. For participants who are not literate, the questionnaire will be administered by a trained psychiatrist through structured interviews. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in Laboratory Parameters and ECG | Baseline and Week 12 | Safety will be assessed through laboratory investigations including complete blood count, liver and renal function tests, fasting glucose, and lipid profile, as well as 12-lead ECG. Abnormal values or clinically significant changes from baseline will be recorded. |
| Change in Body Mass Index (BMI) | Baseline, Week 6, and Week 12 | BMI will be calculated as weight (kg) divided by height squared (m²). Height will be measured once at Baseline (without shoes, using a stadiometer) and used for all BMI calculations. Weight will be measured at each visit on a calibrated digital scale with participants in light clothing and no shoes. The reported outcome will be BMI (kg/m²) at each time point and the change from Baseline. Weight and height are collected only to compute BMI and will not be reported as separate outcomes. |
Countries
Bangladesh
Contacts
Primary ContactMohammad Tariqul Alam Principal Investigator, MBBS, FCPS (Psychiatry)
Backup ContactDr. Ahsan Aziz Sarkar Co-investigator, MBBS, FCPS (Psychiatry)
Outcome results
None listed