| CTRI Number |
CTRI/2020/03/024007 [Registered on: 16/03/2020] Trial Registered Prospectively |
| Last Modified On: |
16/03/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of transcranial direct current stimulation for treating obsessive compulsive symptoms in Schizophrenia |
|
Scientific Title of Study
|
Efficacy of Transcranial direct current stimulation in treatment of obsessive compulsive symptoms in Schizophrenia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hema Tharoor |
| Designation |
Consultant Psychiatrist |
| Affiliation |
Schizophrenia Research Foundation |
| Address |
Schizophrenia Research Foundation, Department of psychiatry, Room number: 6 R/7A, North Main Road, Anna Nagar West Extension, chennai
Chennai
TAMIL NADU
600101
India |
| Phone |
04426151073 |
| Fax |
04426153971 |
| Email |
hematharoor@scarfindia.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Hema Tharoor |
| Designation |
Consultant Psychiatrist |
| Affiliation |
Schizophrenia Research Foundation |
| Address |
Schizophrenia Research Foundation, Department of psychiatry, Room number: 6 R/7A, North Main Road, Anna Nagar West Extension, chennai
Chennai
TAMIL NADU
600101
India |
| Phone |
04426151073 |
| Fax |
04426153971 |
| Email |
hematharoor@scarfindia.org |
|
Details of Contact Person
Public Query
|
| Name |
Hema Tharoor |
| Designation |
Consultant Psychiatrist |
| Affiliation |
Schizophrenia Research Foundation |
| Address |
Schizophrenia Research Foundation, Department of psychiatry, Room number: 6 R/7A, North Main Road, Anna Nagar West Extension, chennai
Chennai
TAMIL NADU
600101
India |
| Phone |
04426151073 |
| Fax |
04426153971 |
| Email |
hematharoor@scarfindia.org |
|
|
Source of Monetary or Material Support
|
| Schizophrenia Research Foundation, R/7A, North Main Road, Anna Nagar West Extension, chennai |
|
|
Primary Sponsor
|
| Name |
Schizophrenia Reserach Foundation |
| Address |
R/7A, North Main Road, Anna Nagar West Extension, Chennai - 600101 |
| Type of Sponsor |
Other [Non-governmental organisation] |
|
|
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 |
| hematharoor |
Schizophrenia Research Foundation |
Schizophrenia Research Foundation, Department of psychiatry, Room number: 6 R/7A, North Main Road, Anna Nagar West Extension, chennai
Chennai
TAMIL NADU |
04426151073
04426153971
hematharror@scarfindia.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of SCARF |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F20||Schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Active TDCS group |
2 mA of current stimulation for 30 mins. total of 10 sessions ( 2 sessions per day for 5 days) |
| Comparator Agent |
Sham control group |
Active current for the first 20sec of the session, with brief current pulse for the remaining 30 minutes. total of 10 sessions (2 sessions per day for 5 days) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Schizophrenia Patients (ICD -10 Diagnosis ) aged 18-50 years
Moderate to severe rating on YBOCS (score of 15 >)
Consenting for the study.
No change in medications or other add on treatments during the study period. |
|
| ExclusionCriteria |
| Details |
• Patient who have undergone tDCS treatment in the last 3 months.
• Patients with mental retardation, H/O drug or alcohol dependence, epilepsy and pregnant women.
• Patient receiving ECT.
• Existence of serious medical/neurological disorder.
• Patients who are uncooperative due to the severity of the illness.
• Not consenting to participate in the study. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in YBOCS(Yale brown obsessive compulsive scale ) score compared to baseline after 5 days (10 sessions / 2 sessions per day) and 1 month of intervention. |
Baseline
After 5 days of treatment and After 1 month post treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in YBOCS ratings and overall functioning scores using SOFAS (social and occupational functioning) & CGI ( Clinical global impression) at 1 month compared to preintervention scoring. |
1 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
16/03/2020 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a double blind sham controlled study to test the efficacy of transcrational direct current stimulation on obsessive compulsive symptoms in schizophrenia. All patients fulfilling the inclusion and exclusion criteria will recruited for the study for a period of one month. The obsessive and compulsive symptoms will be measured using the Yale brown obsessive compulsive scale. the patients functioning will be measured using the social and occupational functioning scale. Their improvement will be measured using the clinical global improvement scale. |