Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-25 @ 7:40 PM
Study NCT ID:
NCT07153835
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-04
First Post:
2025-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Paliperidone in Schizophrenia - Bangladesh Study
Sponsor:
Sher-E-Bangla Medical College
Organization:
Study Overview
Official Title:
Evaluation of Efficacy and Safety of Paliperidone Among People With Schizophrenia in Bangladesh
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: