SchizophreniaPhase 4NCT07153835
Efficacy and Safety of Paliperidone in Schizophrenia - Bangladesh Study
A Phase 4 study testing Paliperidone extended-release (ER) in people with Schizophrenia, run by Sher-E-Bangla Medical College at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Paliperidone extended-release (ER)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 505 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Sep 2025to 31 Jul 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mohammad Tariqul Alam Principal Investigator, MBBS, FCPS (Psychiatry) contact
Dr. Ahsan Aziz Sarkar Co-investigator, MBBS, FCPS (Psychiatry) contact
Bangladesh1 site
Sher-E-Bangla Medical College Hospital
Barishal, 8200
Mohammad Tariqul Alam Principal Investigator, FCPS, +8801818222228, sum.tariq@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Paliperidone extended-release (ER)
- Keywords
- Schizophrenia, Paliperidone, Extended-Release Paliperidone, Second-Generation Antipsychotics, PANSS, GASS, WHOQOL-BREF, Quasi-Experimental Study, Efficacy, Safety
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paliperidone extended-release (ER)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Paliperidone Extended-Release Treatment Arm | Experimental | Participants in this arm will receive paliperidone extended-release (ER) tablets at a flexible daily dose of 6-12 mg, as determined by the treating psychiatrist based on clinical judgment. The treatment will continue for 12 weeks, with clinical assessments at baseline, 6 weeks, and 12 weeks to evaluate efficacy, safety, and quality of life. Receives: Drug: Paliperidone extended-release (ER) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PANSS total score from baseline to 12 weeks
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.
Measured: Baseline, Week 6, Week 12
Secondary outcomes (2)
Assessment of Side Effects Using GASS Score
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.
Measured: Baseline, Week 6, and Week 12
Changes in Quality of Life Measured by WHOQOL-BREF
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.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm, open-level, multicenter, prospective, quasi-experimental study
- Masking
- None (open label)
- Enrolment
- 505 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sher-E-Bangla Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- ACI Pharmaceuticals, US-Bangla Medical College Hospital, Dr. M M Jalal Uddin, Dr.Ahsan Aziz Sarkar
- Responsible party
- Principal investigator, Mohammad Tariqul Alam, Sher-E-Bangla Medical College
- Investigators
- Dr. M M Jalal Uddin Co-invetigator, MBBS,FCPS (Psychiatry), MPH, Study director, National Institute of Neurosciences and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153835
- Sponsor's protocol ID
- IRB/USBMC/2025/001
- Status last verified
- Aug 2025
- First submitted
- 16 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) may not be shared publicly, as the decision to share lies with the trial sponsor, ACI Pharmaceuticals.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety of Paliperidone Among People With Schizophrenia in Bangladesh
- ClinicalTrials.gov ID
- NCT07153835
- Acronym / sponsor ID
- IRB/USBMC/2025/001
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Paliperidone, Extended-Release Paliperidone, Second-Generation Antipsychotics, PANSS, GASS, WHOQOL-BREF, Quasi-Experimental Study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 505 participants (estimated)
- Lead sponsor
- Sher-E-Bangla Medical CollegeUniversity, hospital or other
- Collaborators
- ACI Pharmaceuticals, US-Bangla Medical College Hospital, Dr. M M Jalal Uddin, Dr.Ahsan Aziz Sarkar
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, open-level, multicenter, prospective, quasi-experimental study
| Arm | Type | Receives |
|---|---|---|
| Paliperidone Extended-Release Treatment Arm | Experimental | Drug: Paliperidone extended-release (ER)Participants in this arm will receive paliperidone extended-release (ER) tablets at a flexible daily dose of 6-12 mg, as determined by the treating psychiatrist based on clinical judgment. The treatment will continue for 12 weeks, with clinical assessments at baseline, 6 weeks, and 12 weeks to evaluate efficacy, safety, and quality of life. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Paliperidone Extended-Release Treatment Arm |
Primary outcome
Change in PANSS total score from baseline to 12 weeks
Time frame: 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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) may not be shared publicly, as the decision to share lies with the trial sponsor, ACI Pharmaceuticals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohammad Tariqul Alam Principal Investigator, MBBS, FCPS (Psychiatry) contact
Dr. Ahsan Aziz Sarkar Co-investigator, MBBS, FCPS (Psychiatry) contact
Dr. M M Jalal Uddin Co-invetigator, MBBS,FCPS (Psychiatry), MPH study director
National Institute of Neurosciences and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paliperidone extended-release (ER) in people with Schizophrenia, run by Sher-E-Bangla Medical College at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Tariqul Alam Principal Investigator, MBBS, FCPS (Psychiatry) (+8801818222228, sum.tariq@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PANSS total score from baseline to 12 weeks (time frame: Baseline, Week 6, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.