Health Condition 1: F322- Major depressive disorder, singleepisode, severe without psychotic features
Conditions
Interventions
Intervention1: Sub-convulsive mECT Stimulation protocol: The stimulus intensity will be determined by a dose titration procedure (starting at 25.2mC) and seizure threshold will be identified in the fi
Sponsors
All India Institute of Medical Sciences New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age 18-60 years 2.Willing to give informed consent 3.Ability to read Hindi or English language 4.Fulfilling criteria of major depressive disorder as per Diagnostic and Statistical Manual 5th version (DSM 5) in group 1 & 2 5.Treatment resistance will be defined as the failure to respond to 2 adequate trials of different classes of antidepressant medications (Sackeim, 2001) 6.Patients referred for ECT (for all study patients, a clinical decision to pursue neuromodulation would have already been made. Clinical treatment will be performed independently of this study). 7.No changes in psychiatric medications for at least one month prior to study and willingness to not change during study
Exclusion criteria
Exclusion criteria: 1.Patients with chronic neurological or other physical illness (like coronary artery disease or cardiac arrhythmia) 2.Suffering from any other psychiatric disorder other than major depressive disorder in their respective groups 3.Persistent mood disorders (dysthymia) and other and unspecified depressions based on DSM 5 4.History of significant head trauma 5.Patients with ongoing alcohol or other substance abuse or dependence (except nicotine and caffeine) 6.Any history of seizure 7.Previous history of receiving any surgical procedures or electrical or magnetic stimulation on brain 8.Known or suspected pregnancy or lactating females 9.History of serious, potentially life-threatening reaction to anesthesia or succinylcholine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Significant improvement in depressive symptoms defined as more than 50 percent reduction in baseline HAMD scores will be the primary clinical outcomeTimepoint: At baseline before first mECT session and at 3rd week after 8 mECT sessions | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in activation & connectivity seen on fNIRS & qEEG during resting state as well as activation state (in response to emotional tasks) scans & changes in BDNF levels will be correlated to clinical changes of scoresTimepoint: At baseline before first mECT session & at 3rd week after 8 mECT sessions;Side effects in both groups will be assessed to compare the tolerability of the procedureTimepoint: At baseline before first mECT session & at 3rd week after 8 mECT sessions | — |
Countries
India
Contacts
Public ContactRohit Verma
All India Institute of Medical Sciences
Outcome results
None listed