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CTRI Number  CTRI/2024/06/069483 [Registered on: 26/06/2024] Trial Registered Prospectively
Last Modified On: 17/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Risperidone or Aripiprazole addition to Selective Serotonin Reuptake Inhibitors for treating Obsessive Compulsive Disorder 
Scientific Title of Study   Comparative effectiveness of Risperidone versus Aripiprazole augmentation to Selective Serotonin Reuptake Inhibitors in Obsessive Compulsive Disorder 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  C Nikhilesh 
Designation  Post Graduate Junior Resident 
Affiliation  Government Medical College and Hospital 
Address  Department of Psychiatry, Level 5, D block, Government Medical College and Hospital, Sector 32 Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  7696112399  
Fax    
Email  nikhilesh.challa@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shivangi Mehta 
Designation  Assistant Professor 
Affiliation  Government Medical College and Hospital 
Address  Department of Psychiatry, Level 5, D block, Government Medical College and Hospital, Sector 32 Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9855784512  
Fax    
Email  shivangi02@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shivangi Mehta 
Designation  Assistant Professor 
Affiliation  Government Medical College and Hospital 
Address  Department of Psychiatry, Level 5, D block, Government Medical College and Hospital, Sector 32 Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9855784512  
Fax    
Email  shivangi02@gmail.com  
 
Source of Monetary or Material Support  
Government Medical College and Hospital, Sector 32, Chandigarh 
 
Primary Sponsor  
Name  Government Medical College and Hospital 
Address  Sector 32, Chandigarh, Pin code 160030 
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 C Nikhilesh  Government Medical College and Hospital  Department of Psychiatry, Level 5, D Block, Government Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH 
7696112399

nikhilesh.challa@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: F422||Mixed obsessional thoughts and acts,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Aripiprazole  Antipsychotic drug, Dose: 2.5 mg-10 mg, Route: oral, Frequency: Daily, Period: 8 weeks. 
Intervention  Risperidone  Antipsychotic drug, Dose: 1-3 mg, Route: oral, Frequency: Daily, Period: 8 weeks.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients fulfilling the criteria for OCD as per ICD-11 and on treatment with a dose within therapeutic range for one or more than one SSRIs for 12 weeks and current YBOCS ≥16 
 
ExclusionCriteria 
Details  1. Patients with evidence of dementia, organic brain disorders like epilepsy, tumours,
neurological lesions, stroke
2. Patients on Tricyclic Antidepressants
3. Patients with Intellectual Disability
4. Patients with substance dependence except nicotine and caffeine
5. Patients with co-morbid major mental illness
6. Past history of augmentation with risperidone or aripiprazole
7. History of hypersensitivity/allergic reaction to risperidone and aripiprazole 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Compare clinical response to both the drugs which would be measured by reduction in the Y-BOCS and CGI scores  0, 2, 4, 6, 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Compare effect on QoL (measured by WHOQOL-BREF
Hindi), sexual functioning (measured by ASEX), cognitive functioning (measured by HMoCA, DSST, TMT, DST), depressive and anxiety symptoms (measured by HDRS-17, HAM-A),
and, also to assess the safety profile of both the drugs (measured by GASS) 
0, 2, 4, 6, 8 weeks 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  
72 consecutive patients meeting the inclusion and exclusion criteria and giving written informed consent for participation in the study shall be recruited. The socio demographic and clinical details shall be recorded on the semi-structured proforma developed for the study. Baseline scales - Yale-Brown Obsessive Compulsive Scale (YBOCS), Hamilton Depression Rating Scale (HDRS-17), Hamilton Anxiety Rating Scale (HAM-A), Clinical Global Impressions - Severity (CGI-S), Clinical Global Impressions - Improvement (CGI-I), Arizona Sexual Experience Scale (ASEX), and World Health Organization Quality-of-Life Scale (WHOQOL-BREF) will be assessed in all the 72 patients of the study. Baseline objective cognitive functions will be assessed by using cognitive tests (Digit Symbol Substitution test, Trail Making Test, Digit Span Test, Hindi - Montreal Cognitive Assessment) in all the patients. Baseline routine investigations will be carried out - Complete blood counts (Hemoglobin, TLC, DLC, Platelet count), Lipid profile, FBS and ECG. The cases will be divided into two groups of 36 cases each using a computer-generated random table. Any participant with gross impairment in the routine investigations shall be referred for medical consultation. Patients in Group A will receive Risperidone and those in Group B will receive Aripiprazole. Both the drugs will be administered orally. Risperidone will be started at 1 mg/day and Aripiprazole at 2.5 mg/day on day 1. Dose titration will be done based on response and tolerability specific to each patient. The dose can be increased maximally to 3 mg for Risperidone and 10 mg for Aripiprazole and the same can be achieved if required within 2 weeks of the start of the study (1-3 mg for Risperidone and 2.5-10 mg for Aripiprazole). If at any point, any patient withdraws the consent or does not come for 2 consecutive follow-ups despite telephonic reminder, he/she will be considered dropped out of the study. The empty strips will be checked at each follow-up to ensure compliance, besides ensuring compliance from caregiver. The patients shall be stabilized for the next 6 weeks on the same dose and final response at 8 weeks will be assessed. No change in the dose of SSRIs will be made during the study period. The patients shall be followed up and assessed with the scales (Y-BOCS, HDRS-17, HAM-A, ASEX, GASS) at 2 weeks, 4 weeks , 6 weeks and 8 weeks follow up. Cognitive tests shall be administered at 8 weeks followup. At 8 weeks follow up, patients shall be assessed using the scales and cognitive tests and routine investigations including, complete blood counts (Hemoglobin, TLC, DLC, Platelet count), Lipid profile, FBS and ECG shall be repeated. For the purpose of the study, the response will be taken as 25 percent reduction in Y-BOCS score from baseline. Those who have a 25 percent reduction in Y-BOCS score will be termed as responders and those who do not meet this criteria will be termed as non-responders. In case patient is taking benzodiazepines, the same shall be documented and efforts will be made to ensure the same 48 hours before the cognitive assessment prior to the final assessment at 8th week of follow up. Primary outcome of the study would be to compare clinical response to both the drugs which would be measured by reduction in the Y-BOCS and CGI scores. The secondary outcomes would be to compare effect on QoL (measured by WHOQOL-BREF Hindi), sexual functioning (measured by ASEX), cognitive functioning (measured by HMoCA, DSST, TMT, DST), depressive and anxiety symptoms (measured by HDRS-17, HAMA), and, also to assess the safety profile of both the drugs (measured by GASS). After collection of data, all the data shall be computed in IBM SPSS Statistics (version 26.0) software and statistical analysis would be done for the same as mentioned in the succeeding section on statistical analysis. If at any point, any patient withdraws the consent, he/she will be considered dropped out of the study.
 
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