CTRI Number |
CTRI/2018/02/011890 [Registered on: 13/02/2018] Trial Registered Retrospectively |
Last Modified On: |
15/02/2018 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Medical Device |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
To compare the efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) as an augmentation strategy vs conventional treatment of depression |
Scientific Title of Study
|
A study to compare the efficacy of high frequency repetitive Transcranial Magnetic Stimulation (rTMS) as an augmentation strategy vs conventional treatment of non psychotic, unipolar depression in a tertiary care hospital in Western Maharashtra |
Trial Acronym |
rTMSAFMC |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Amit Chail |
Designation |
Resident (Psychiatry) |
Affiliation |
Armed Forces Medical College, Pune |
Address |
Dept of Psychiatry, Armed Forces Medical College, Pune
Pune MAHARASHTRA 411040 India |
Phone |
9673994438 |
Fax |
|
Email |
doc.chail@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Rajiv K Saini |
Designation |
Asst Prof |
Affiliation |
Armed Forces Medical College, Pune |
Address |
Dept of Psychiatry, Armed Forces Medical College, Pune
Pune MAHARASHTRA 411040 India |
Phone |
9168756403 |
Fax |
|
Email |
rks197019@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Rajiv K Saini |
Designation |
Asst Prof |
Affiliation |
Armed Forces Medical College, Pune |
Address |
Dept of Psychiatry, Armed Forces Medical College, Pune
Pune MAHARASHTRA 411040 India |
Phone |
9168756403 |
Fax |
|
Email |
rks197019@gmail.com |
|
Source of Monetary or Material Support
|
Armed Forces Medical College, Pune, 411001 |
|
Primary Sponsor
|
Name |
Director General Armed Forces Medical Services |
Address |
O/o DGAFMS, North Block New Delhi |
Type of Sponsor |
Government funding agency |
|
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 Amit Chail |
Command Hospital, Southern Command, Pune |
Dept of Psychiatry, Ward no 11, Command Hospital Southern Command Pune MAHARASHTRA |
9673994438
doc.chail@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Medical Research Cell and Institutional Etthics Committee, AFMC |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Depressive Episode, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
rTMS along with anti-depressant treatment |
ATES magnetic stimulator, RTS 9000, high frequency stimulation more than 5Hz, over Left PFC.They are also given anti-depressant treatment |
Comparator Agent |
Standard Anti-depressant treatment |
Control arm to be given standard anti-depressant treatment |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1. Patients suffering from unipolar depression (non psychotic, Single episode or recurrent depression) - diagnosed as per ICD-10 criteria by a qualified psychiatrist.
2. Pass the TMS adult safety screening (TASS) test
|
|
ExclusionCriteria |
Details |
1. Suicidal patient
2. Psychotic depression
|
|
Method of Generating Random Sequence
|
Random Number Table |
Method of Concealment
|
Other |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Response as measured by reduction in HAM-D score by 50 % |
0 and 4 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
Partial Response as measured by reduction in HAMD score between 25% and 50 % |
0 and 4 weeks |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
02/01/2017 |
Date of Study Completion (India) |
20/01/2018 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
Not yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Episodes of depression are frequently associated with
significant psychosocial deterioration. Depression is a common psychiatric
disorder that presents with depressed mood, loss of interest or pleasure,
decreased energy, feelings of guilt or low self-worth, disturbed sleep or
appetite, and poor concentration. Moreover, depression often comes with
symptoms of anxiety. These problems can become chronic or recurrent and lead to
substantial impairments in an individual’s ability to take care of his or her
everyday responsibilities.
rTMS
therapy uses a computerized, electromagnetic medical device to produce and
deliver non-invasive, magnetic stimulation using brief duration, rapidly
alternating, or pulsed, magnetic fields to induce electrical currents directed
at spatially discrete regions of the cerebral cortex. When pulses of TMS are
delivered repetitively, this is called repetitive TMS, or rTMS. These pulses
can be delivered at either high (10–20 Hz) or low frequency (less than or equal
to 1 Hz) . Most clinical TMS treatments delivered for treating depression are
typically given at 10 Hz to 18 Hz . The peak magnetic field strength achieved
with each pulse is approximately 1.5 Tesla, right underneath the coil. TMS
magnetic fields are focal and brief3. In 2008, the United States Food and Drug
Administration (FDA) cleared the first TMS device for therapeutic clinical use
in Major Depressive Disorder (MDD).
The
course may be somewhat protracted—up to 2 years or longer—in those with the
single-episode form. However with effective treatment the total
duration of the episode and morbidity in terms loss of work or college hours,
disturbed social relations and reduced attention and concentration can be
reduced. Effective treatment also prevents progression of mild-moderate depressive
episode to severe.
rTMS i.e. repeated
transcranial magnetic stimulation has emerged as a new somatic modality of treatment strategy for patients with
depression. However, there are no studies on the Indian subjects
regarding efficacy and superiority of r TMS in unipolar non-psychotic
depression over existing therapeutic modalities. The current study aims to
ascertain superiority of r TMS over standard medical care in unipolar non
psychotic depression |