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CTRI Number  CTRI/2023/01/049307 [Registered on: 31/01/2023] Trial Registered Prospectively
Last Modified On: 10/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Olanzapine and Risperidone on clinical and biochemical profile of persons with Schizophrenia. 
Scientific Title of Study   Effect of Olanzapine and Risperidone on clinical and biochemical profile of persons with Schizophrenia. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Karan Singh Nagarkoti 
Designation  PGJR 
Affiliation  Government Medical College and Hospital, Sector 32, Chandigarh 
Address  Department of Psychiatry, Level-5, E-block, Government Medical College and Hospital, Sector-32

Chandigarh
CHANDIGARH
160030
India 
Phone  9413171718  
Fax    
Email  karansn13@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ajeet Sidana 
Designation  Professor 
Affiliation  Government Medical College and Hospital, Sector 32, Chandigarh 
Address  Department of Psychiatry, Level-5, E-block, Government Medical College and Hospital, Sector-32

Chandigarh
CHANDIGARH
160030
India 
Phone  9056422679  
Fax    
Email  ajeetsidana@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Karan Singh Nagarkoti 
Designation  PGJR 
Affiliation  Government Medical College and Hospital, Sector 32, Chandigarh 
Address  Department of Psychiatry, Level-5, E-block, Government Medical College and Hospital, Sector-32

Chandigarh
CHANDIGARH
160030
India 
Phone  9413171718  
Fax    
Email  karansn13@gmail.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  Government Medical College and Hospital 
Address  Sector-32, Chandigarh 
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 
Dr Karan Singh Nagarkoti  Government medical college and hospital, Sector-32  Room No.4212, Psychiatry OPD, Level-4, B-Block, GMCH-32
Chandigarh
CHANDIGARH 		 9413171718

karansn13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee (GMCH, Chandigarh)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F20||Schizophrenia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Olanzapine  Olanzapine is an atypical antipsychotic approved for use in Schizophrenia. It will be given at the approved of 5-20mg/day for 10weeks. 
Comparator Agent  Risperidone  Risperidone is an atypical antipsychotic approved for use in Schizophrenia. It will be given at a dose of 2-16mg/day for 10weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Diagnosis of schizophrenia according to ICD-11
Drug naïve or not on any antipsychotic drug from past 4 weeks
 
 
ExclusionCriteria 
Details  Patients with co-morbid substance dependence (except nicotine and caffeine)
Patients who are lactating or pregnant.
Patients with any unstable medical (hypothyroidism, diabetes insipidus, kidney disease, liver disease, chronic heart disease) neurological or surgical disorders.
Patients with history of active infection in last 2 weeks.
Patients with history of autoimmune diseases.
Patients on any immunosuppressant drug.
Acutely suicidal patients.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess and compare the levels of interleukins and TNF-alpha in patients of schizophrenia on olanzapine and risperidone.  0week, 2weeks, 10weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To assess and compare the early response in relation to changes in interleukins and TNF-alpha levels.  0 week, 2weeks, 10 weeks 
To assess and compare the clinical response, Quality of Life (QoL) and sexual wellbeing with olanzapine and risperidone.  0week, 10weeks 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="74" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/02/2023 
Date of Study Completion (India) 17/05/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 The study will be conducted in Department of Psychiatry, Government Medical College and Hospital, Sector-32 (GMCH-32), Chandigarh. A total of 74 consecutive patients diagnosed with schizophrenia as per ICD-11 coming to OPD or IPD will be evaluated based upon the inclusion and exclusion criteria mentioned above. After obtaining informed consent of the patients or their nominative representative they will be randomly assigned to Group A (Risperidone) and B (Olanzapine)by using computer generated random number table. Both of these medications are available free of cost at GMCH pharmacy. Dosage of respective drugs will be kept in therapeutic range of 2-16mg and 5-20mg for Risperidone and olanzapine respectively. For risperidone, initial approved recommendation being 2-4mg/day going up to 16mg/day and for olanzapine initial dose of 5-10mg/day, maximum 20mg/day. The attending clinician will reach the maximum tolerable therapeutic dose within 2-4 weeks of initiation of pharmacotherapy. Patient will be started with minimum effective dose of 2mg for risperidone and 5mg for olanzapine. Patient will then be evaluated at 1 week for side effects by administering Glasgow Antipsychotic Side-effect Scale (GASS) and response to treatment. Thereafter, dose can be up-titrated at this time depending on clinical status and symptomatology. On the next follow up at 2weeks on the basis of their response to treatment they will be labelled early responders (≥20% reduction in PANSS Score) and early non-responders. In both early responders and early non-responders the dose will be further up-titrated to maximum tolerable dose by the end of 4 weeks. If during up titration of dose, patient is unable to tolerate, the dose will be reduced to half and gradual escalation will be done. And if at any point of time if patient develops severe side effects or the patient withdraws his consent to continue in the study, the patient will be dropped out from the study and managed accordingly. If any patient gets pregnant during the course of this study, then that patient will be dropped out from the study and managed accordingly. After reaching maximum tolerable dose by 4weeks the patients will be kept at same dose for the next 6weeks. Patients will be followed up at week 1,2,4,6,8 and 10. A reminder call will be given a day prior to follow up to ensure continuation of treatment and patients will be asked to bring empty medicines strips to check compliance to medication. Depending upon the level of improvement at 10 weeks patients will be labelled as responders (≥50% improvement in PANSS) and non-responders (<50% improvement in PANSS). The dosage will be kept in therapeutic range by the treating clinicians. During the study, concomitant medications like anticholinergic drugs for extrapyramidal symptoms and benzodiazepine for sleep disturbance and agitation will be permitted whenever required and doses of such medications will be documented in each group. 
The levels of TNF-alpha, IL-1beta and IL-6 will be assessed at 0week, 2weeks and 10weeks. The Quality of life and sexual well being will be assessed at 0week and 10weeks. This study will widen our understanding of the disease process by the use of both clinical parameters and inflammatory markers(TNF-alpha, IL-6, IL-1beta) concurrently while predicting treatment response by two weeks. This study will also explore quality of life in terms already established determinants while also providing us a new opportunity to study the role of TNF- α and interleukins in determining the quality of life in persons with schizophrenia. Sexual well-being in persons with schizophrenia and the effect of treatment on it will also be explored in this study.
 
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