| CTRI Number |
CTRI/2021/07/035182 [Registered on: 27/07/2021] Trial Registered Prospectively |
| Last Modified On: |
22/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Other (Specify) [rTMS] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of Theta Burst Transcranial Magnetic Stimulation in Bipolar Depression : A randomized Placebo Controlled Trial |
|
Scientific Title of Study
|
Efficacy of Adjunctive Theta Burst Transcranial Magnetic Stimulation in Bipolar Depression -A Randomized Placebo Controlled Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gunjan Malik |
| Designation |
Research Scholar |
| Affiliation |
SGRRM&HS |
| Address |
Department of Psychiatry
Shri Mahant Indresh Hospital
Patel Nagar
Room No. 92
Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9675404080 |
| Fax |
|
| Email |
gunjanmalikddn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shobit Garg |
| Designation |
Professor |
| Affiliation |
SGRRM&HS |
| Address |
Department of Psychiatry
Shri Mahant Indresh Hospital
Patel Nagar
Room No. 92
Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
8958534261 |
| Fax |
|
| Email |
shobit.garg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gunjan Malik |
| Designation |
Research Scholar |
| Affiliation |
SGRRM&HS |
| Address |
Department of Psychiatry
Shri Mahant Indresh Hospital
Patel Nagar
Room No. 92
Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9675404080 |
| Fax |
|
| Email |
gunjanmalikddn@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SGRRIMHS |
| Address |
SGRRIM&HS ,Patel Nagar , Dehradun , Uttaranchal 248001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shobit Garg |
SGRRIM&HS |
Department of Psychiatry
Shri Mahant Indresh Hospital
Patel Nagar
Room No. 92
Dehradun
UTTARANCHAL |
8958534261
shobit.garg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGRRIM&HS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F314||Bipolar disorder, current episodedepressed, severe, without psychotic features, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
cTBS |
cTBS treatment will be delivered over rDLPFC for 3 sessions for 5 days a week spaced 30 minutes apart.A stimulation intensity of 80 % of the motor threshold (MT) of the right abductor pollicis brevis muscle will be used. |
| Comparator Agent |
Sham cTBS |
The sham coil has been used same as active coil but is not associated with a stimulus sensation .It just give sound as active one. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
1) Diagnosis of moderate to severe Bipolar disorder with current episode of Depression
2) Baseline HAM-D Score >18
3) Right Handed nor Mo tensive patient |
|
| ExclusionCriteria |
| Details |
1) Neurological Disorder such as epilepsy,organic brain damage or any neurological procedure.
2) Pacemakers or other metal parts in the body
3) ECT in the past 6 months
4) Any comorbid Psychosis
5) History of non response to rTMS treatment
6) Alcohol or any other substance dependence except Nicotine and Caffine |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the change in Depressive symptoms in Bipolar Depression among active and placebo group |
Screening ,Baseline ,7th Day post initiation of therapy, 21st Day post initiation of therapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess and compare change in quality of life in bipolar depression |
Baseline ,7th Day post initiation of therapy, 21st Day post initiation of therapy |
| To assess and compare change in anxiety symptoms in bipolar depression |
Baseline ,7th Day post initiation of therapy, 21st Day post initiation of therapy |
| To assess and compare change in sexual dysfunction in bipolar depression |
Baseline ,7th Day post initiation of therapy, 21st Day post initiation of therapy |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
09/08/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to investigate the clinical efficacy of continuous theta burst stimulation (cTBS) on the right DLPFC in bipolar depression. For this study Bipolar depressed patients will be selected by a certified psychiatrist. The presence of exclusion criteria will be evaluated. Eligible patients will undergo Baseline clinical assessments and research assessments. TBS involves applying triple-pulse 50 Hz bursts given at a rate of 5 Hz uninterrupted trains (1). Patients will be treated with in total 15 (3 sessions per day)continuous Theta Burst Stimulation (cTBS) session (200 pulses per session) over the right dorsolateral prefrontal cortex, which will be spread over 5 days a week. A stimulation intensity of 80% of the subject’s motor threshold (MT) of the right abductor pollicis brevis muscle will used. Patients will be randomized to receive either the real cTBS or sham treatment. Sham stimulation will be applied with a sham coil. The sham coil produces identical sounds but is not associated with a stimulus sensation compared to the coil delivering real stimulation cTBS. Two post-treatment assessment will take place respectively 7 days and 21 days post initiation of treatment .
1. (1) Chung S, Hoy K , Fitzgerald P. Theta-burst stimulation: a new form of TMS treatment for depression. Depression and Anxiety .2014;32(3): 182-192. |