Health Condition 1: F33- Major depressive disorder, recurrent Health Condition 2: F32- Major depressive disorder, singleepisode
Conditions
Interventions
Intervention1: cathodal transcranial Direct Current Stimulation (tDCS) primed intermittent Theta Burst Stimulation (iTBS): The cathode placed over the left dorsolateral prefrontal cortex (DLPFC), with
2s on and 8s off, 600pulses per session, the total duration of 3min and 9s delivered at 120% of Resting motor threshold, one session per day for 20 days (4 weeks).
If the improvement Hamilton depress
Sponsors
Department of Psychiatry National Institute of Mental Health and Neuro Sciences
Central Institute of Psychiatry
Kasturba Medical College
Eligibility
Inclusion criteria
Inclusion criteria: 1.Major Depressive Disorder Diagnosis (DSM-5) 2.Right-handed (Edinburgh Handedness Inventory) 3.Hamilton Depression Rating Scale (HAMD-17) score of 18 or more 4.No clinical response to an adequate dose of two antidepressant medications (based on antidepressant treatment history form score) OR Unable to tolerate at least two separate trials of antidepressants of inadequate dose and duration, and if they are currently on a stable antidepressant regimen for at least 4 weeks before which will be continued during treatment 5.Capacity to consent for research studies as per the assessment using the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) 6. Written informed consent.
Exclusion criteria
Exclusion criteria: 1.Resistant to 3 or more antidepressants or to an adequate ECT trial 2.Suicidal intent (HAMD suicide item score of 3 or 4) / any psychiatric emergency 3.Bipolar depression; 4.Psychotic disorder or symptoms; 5.Neurological/clinical evidence of other medical comorbidity that could substantially influence depression; 6.Unstable medical illness; 7.Co-prescribed BZD >1-mg clonazepam equivalents or anti-epileptic drugs; 8.Severe general medical/neurological comorbidity that precludes ECT or has an effect on cognition and behavior; 9.Current psychoactive substance dependence (except caffeine or nicotine); 10.Pregnancy or Post-partum Period; 11.Co-morbid neurological/medical disease that can affect the brain structure/function; 12.Any contraindication for Magnetic Resonance Imaging; 13.Any contraindication for Transcranial Magnetic Stimulation; 14.Any contraindication for Transcranial Direct Current Stimulation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in Hamilton Depression Rating Scale (HAMD-17) score of more than or equal to 50% from baseline and post-treatment HAMD-17 score of 13.Timepoint: 1. Baseline 2. At the end of part-1 (4-6 weeks of cTDCS/sham-tDCS primed iTBS) 3. At the end of part-2 (End of 6 or more sessions of ECT) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Inventory of Depressive Symptomatology-Self Report and Hamilton Anxiety Rating scale scores 2. Structured assessment of disability 3. Brain magnetic imaging measures (resting-state functional images, diffusion tensor images, glutamate levels at left dorsolateral prefrontal cortex from MR spectroscopy) 4. Electroencephalography measures 5. TMS-tDCS perturbation study metrics 6. Heart Rate Variability measuresTimepoint: 1. Baseline 2. At the end of part-1 (4-6 weeks of cTDCS/sham-tDCS primed iTBS) 3. At the end of part-2 (End of 6 or more sessions of ECT) | — |
Countries
India
Contacts
Public ContactUrvakhsh Mehta
National Institute of Mental Health and Neurosciences
Outcome results
None listed