| CTRI Number |
CTRI/2025/11/097443 [Registered on: 14/11/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to find out the efficacy of long-acting paliperidone in improving symptoms and well-being of people with schizophrenia or bipolar disorder. |
|
Scientific Title of Study
|
Effectiveness and Safety of Long-Acting Injectable Paliperidone in Schizophrenia Spectrum and Bipolar Mania: A Prospective Observational Study
|
| Trial Acronym |
Not Applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shankar |
| Designation |
Assistant professor |
| Affiliation |
Government Mohan Kumaramangalam Medical College , salem |
| Address |
DEPARTMENT OF PSYCHIATRY , SALEM
Salem TAMIL NADU 636001 India |
| Phone |
08807286440 |
| Fax |
|
| Email |
shankardrpsy@ymail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Ravishankar |
| Designation |
Professor |
| Affiliation |
Government Mohan Kumaramangalam Medical College , salem |
| Address |
DEPARTMENT OF PSYCHIATRY , SALEM
Salem TAMIL NADU 636001 India |
| Phone |
9952247088 |
| Fax |
|
| Email |
kanishkashankar2016@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Shankar |
| Designation |
Assistant professor |
| Affiliation |
Government Mohan Kumaramangalam Medical College , salem |
| Address |
DEPARTMENT OF PSYCHIATRY , SALEM
Salem TAMIL NADU 636001 India |
| Phone |
08807286440 |
| Fax |
|
| Email |
shankardrpsy@ymail.com |
|
|
Source of Monetary or Material Support
|
| Department of Psychiatry, Government Mohan Kumaramangalam Medical College and Hospital, Salem – 636001, Tamil Nadu, India |
|
|
Primary Sponsor
|
| Name |
Government Mohan Kumaramangalam Medical College and Hospita |
| Address |
Department of Psychiatry, Government Mohan Kumaramangalam Medical College and Hospital, Salem – 636001, Tamil Nadu, India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DRSShankar |
Government Mohan Kumaramangalam Medical College and Hospital |
Room No.66, Department of Psychiatry, Government Mohan Kumaramangalam Medical College and Hospital, Salem – 636001, Tamil Nadu, India Salem TAMIL NADU |
08807286440
shankardrpsy@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Mohan Institutional Ethics Committee Office, Government Mohan Kumaramangalam Medical College and Hospital, Salem |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F200||Paranoid schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Long acting injectable paliperidone |
Long-acting injectable paliperidone
Details:
Administered as intramuscular deep injection, dose 100 mg or 150 mg once monthly, continued for a total duration of 12 months. |
| Comparator Agent |
Type: Comparator/Control
Name: Not Applicable
Details: Single arm observational study. No comparator or control group |
Type: Comparator/Control
Name: Not Applicable
Details: Single arm observational study. No comparator or control group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ICD 11 diagnosis of schizophrenia, schizoaffective disorder, or bipolar mania.
Initiated on long acting injectable paliperidone for at least six weeks.
Age between 18 to 65 years, any gender. |
|
| ExclusionCriteria |
| Details |
Diagnosis of bipolar depression or other psychotic disorders such as delusional disorder.
Presence of comorbid substance use disorder except nicotine.
Use of concurrent psychotropic medications. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients achieving at least fifty percent improvement in Clinical Global Impression Improvement (CGI I) score at twelve months. |
Outcomes will be assessed at Baseline, six months, and twelve months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of metabolic & safety parameters including extrapyramidal symptoms weight BMI changes serum prolactin & glucose levels during treatment with long acting injectable paliperidone |
At 6 months & 12 months |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| Date of Study Completion (India) |
07/02/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
07/02/2026 |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective observational Phase Four post marketing surveillance study planned to evaluate the effectiveness and safety of long acting injectable paliperidone in patients with schizophrenia, schizoaffective disorder, and bipolar mania. The study will be conducted at the Psychiatry Outpatient Department of Government Mohan Kumaramangalam Medical College, Salem.
The primary aim is to assess real world clinical effectiveness of long acting injectable paliperidone. Specific objectives are to evaluate improvement in symptom severity, monitor side effect profile including extrapyramidal symptoms, metabolic changes and prolactin related problems, determine continuation rates and reasons for discontinuation, and compare outcomes across the three diagnostic groups.
Thirty adult patients aged between eighteen and sixty five years of either gender will be recruited by consecutive sampling. Eligible participants will have a confirmed diagnosis of schizophrenia, schizoaffective disorder, or bipolar mania as per ICD Eleven and will have received long acting injectable paliperidone for at least six weeks. Patients with bipolar depression, other primary psychotic disorders, comorbid substance use disorder except nicotine, or those receiving concurrent psychotropic medications will be excluded.
Clinical assessments will include Clinical Global Impression Severity and Improvement scales, Positive and Negative Syndrome Scale for schizophrenia and schizoaffective disorder, Young Mania Rating Scale for bipolar mania, Abnormal Involuntary Movement Scale, Simpson Angus Scale, and metabolic measures such as weight, body mass index, serum prolactin, and blood glucose. These will be recorded at baseline, six weeks, twelve weeks, six months, and twelve months.
The primary outcome is the proportion of patients achieving significant clinical improvement at twelve months. Secondary outcomes include reduction in symptom scores, occurrence of side effects, treatment continuation rates, and potential policy relevance for District Mental Health Programme. The study will follow all ethical standards, and informed consent will be obtained from all participants or their legally authorized representatives when required. |