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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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