| CTRI Number |
CTRI/2018/10/016219 [Registered on: 31/10/2018] Trial Registered Prospectively |
| Last Modified On: |
30/10/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of non invasive brain stimulation to treat depression in adolescents. |
|
Scientific Title of Study
|
Use of Theta burst stimulation in adolescents with depression: Evaluating acceptability, safety, tolerability, and efficacy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Siddhesh Shere |
| Designation |
Senior resident |
| Affiliation |
NIMHANS , Bangalore |
| Address |
405, New Kabini Annexe, Nimhans Hospital, Hosur Road
Nimhans Hospital, Hosur Road, near dairy circle, Banhgalore 560 029
Bangalore
KARNATAKA
560029
India |
| Phone |
9972640914 |
| Fax |
|
| Email |
siddhesh511@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sathish Girimaji |
| Designation |
Senior Professor |
| Affiliation |
NIMHANS , Bangalore |
| Address |
Adolescent psychiatry centre, 2nd floor, Nimhans Hospital, Hosur Road
Bangalore
KARNATAKA
560029
India |
| Phone |
9480829465 |
| Fax |
|
| Email |
drgirimaji@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Siddhesh Shere |
| Designation |
Senior resident |
| Affiliation |
NIMHANS , Bangalore |
| Address |
405, New Kabini Annexe, Nimhans Hospital, Hosur Road
Nimhans Hospital, Hosur Road, near dairy circle, Banhgalore 560 029
KARNATAKA
560029
India |
| Phone |
9972640914 |
| Fax |
|
| Email |
siddhesh511@yahoo.com |
|
|
Source of Monetary or Material Support
|
| NIMHANS HOSPITAL, Hombegowda nagar, Hosur road , Bangalore 560029 |
|
|
Primary Sponsor
|
| Name |
NIMHANS hospital |
| Address |
Hombegowda nagar , hosur road , near dairy circle , Bangalore 560 029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Satish Girimaji |
Dept of child and adolescent psychiatry , NIMHANS , Hombegowda nagar, Hosur road , Bangalore 560 029 |
| Dr Urvaksh Mehta |
Dept of psychiatry , NIMHANS , Hombegowda nagar, Hosur road , Bangalore 560 029 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Siddhesh Shere |
NIMHANS hospital |
Adolescent psychiatry centre, 2nd floor, office room, Nimhans hospital, Hombegowda Nagar, Hosur road , near dairy circle, Bangalore 560 029
Bangalore
KARNATAKA |
9972640914
siddhesh511@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F329||Major depressive disorder, singleepisode, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Single arm |
| Intervention |
Theta Burst Stimulation (TBS) |
TBS refers to a rTMS (repetitive transcranial magnetic stimulation) protocol where pulses are applied in bursts of three, delivered at a frequency of 50 Hz and an inter-burst interval of 200 ms (5 Hz) |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. 12-18 years of age, either gender
2. Moderate – Severe Depression (as per DSM 5)
3. In patients in department of child & adolescent psychiatry,NIMHANS
4. Parents willing to consent for the study |
|
| ExclusionCriteria |
| Details |
1. Intracranial implants (cochlear implants, aneurysmal clips)
2. Acute emergencies like high suicidal risk and catatonia where ECT is considered as a first line treatment
3. Current/Past history / family history of epilepsy
4. Adolescents on Methylphenidate , Bupropion , Clozapine, Tricyclic antidepressants
5. Active Neurological illness / head injury
6. Autism spectrum disorder , Intellectual developmental disorder
7. Organic mood disorders
8. Chronic physical illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure Adverse effect of TMS using structured tool devised by Pascal Leone , Visual analogue scale , Neuropsychological tests and rate of discontinuation |
baseline , daily after TMS sessions , 1 week , 2 week , 3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| efficacy in terms of change in severity of depression over period of 12 weeks as measured by fall in CDRS-R scores |
Baseline , 2 weeks , 3 months |
| acceptability of TBS as a treatment modality as measured by ratio of those who accept TMS as treatment modality to those who were offered same |
2 weeks |
|
|
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 2 |
|
Date of First Enrollment (India)
|
01/11/2018 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Shere, S., Subramanian, S., Bharath, S. & Purushottam, M. Lower levels of serum copper in patients with Alzheimer’s dementia: A controlled study from India. Asian Journal of Psychiatry 32, 73–74 (2018).
Jayarajan, R.N., Shere, S., Sutar, R., Karmani, S., Reddi, V. S. K., Kesavan, M. , Viswanath, B. , Jain, S. (2014). Fluoxetine-induced pulmonary hypertension in a patient with schizophrenia. Journal of Neuropsychiatry and Clinical Neurosciences, 26, 4, E12-E13.
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Primary purpose 1) To study safety , tolerability and acceptance of TBS in adolescents with depression 2) To measure the efficacy of TMS as an add on to standard of care in adolescents with depression.
Hypothesis
1) TMS will be well tolerated by adolescents with minimal to none adverse effects and accepted by adolescents and their families 2) TMS will reduce severity of depression . |