| 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
|
|
|
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
|
|
|
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. |