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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 
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