To compare the efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) as an augmentation strategy vs conventional treatment of depression

Completed

• Conditions: Depressive Episode

• Registration Number: CTRI/2018/02/011890
• Lead Sponsor: Director General Armed Forces Medical Services

Brief Summary

Episodes of depression are frequently associated withsignificant psychosocial deterioration. Depression is a common psychiatricdisorder that presents with depressed mood, loss of interest or pleasure,decreased energy, feelings of guilt or low self-worth, disturbed sleep orappetite, and poor concentration. Moreover, depression often comes withsymptoms of anxiety. These problems can become chronic or recurrent and lead tosubstantial impairments in an individual’s ability to take care of his or hereveryday responsibilities.

rTMStherapy uses a computerized, electromagnetic medical device to produce anddeliver non-invasive, magnetic stimulation using brief duration, rapidlyalternating, or pulsed, magnetic fields to induce electrical currents directedat spatially discrete regions of the cerebral cortex. When pulses of TMS aredelivered repetitively, this is called repetitive TMS, or rTMS. These pulsescan be delivered at either high (10–20 Hz) or low frequency (less than or equalto 1 Hz) . Most clinical TMS treatments delivered for treating depression aretypically given at 10 Hz to 18 Hz . The peak magnetic field strength achievedwith each pulse is approximately 1.5 Tesla, right underneath the coil. TMSmagnetic fields are focal and brief3. In 2008, the United States Food and DrugAdministration (FDA) cleared the first TMS device for therapeutic clinical usein Major Depressive Disorder (MDD).

Thecourse may be somewhat protracted—up to 2 years or longer—in those with thesingle-episode form. However with effective treatment the totalduration of the episode and morbidity in terms loss of work or college hours,disturbed social relations and reduced attention and concentration can bereduced. Effective treatment also prevents progression of mild-moderate depressiveepisode to severe.

rTMS i.e. repeatedtranscranial magnetic stimulation has emerged as a new somatic modality of  treatment strategy for patients withdepression. However, there are no studies on the Indian subjectsregarding efficacy and superiority of r TMS in unipolar non-psychoticdepression over existing therapeutic modalities. The current study aims toascertain superiority of r TMS over standard medical care in unipolar nonpsychotic depression

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-01
• Study Completion: 2018-01-20
• Last Update Posted: 2018-02-15

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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.

Exclusion Criteria

1.Suicidal patient 2.Psychotic depression.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response as measured by reduction in HAM-D score by 50 %	0 and 4 weeks

Secondary Outcome Measures

Name	Time	Method
Partial Response as measured by reduction in HAMD score between 25% and 50 %	0 and 4 weeks

Trial Locations

Locations (1)

Command Hospital, Southern Command, Pune; 🇮🇳 Pune, MAHARASHTRA, India

Command Hospital, Southern Command, Pune

🇮🇳Pune, MAHARASHTRA, India

Dr Amit Chail

Principal investigator

9673994438

doc.chail@gmail.com