Health Condition 1: F332- Major depressive disorder, recurrent severe without psychotic features
Conditions
Interventions
Intervention1: Ketamine Therapy: Infusion of ketamine hydrochloride (0.5mg/kg, IV, over 45min) twice a week (Monday & Friday) given for 6 occasions over 3 weeks.
Control Intervention1: Electro Convuls
Sponsors
All India Institute of Medical Sciences New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18-65 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 5 (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 MECT (for all study patients, a clinical decision to pursue neuromodulation would have already been made. Clinical treatment will be performed independently of this study).
Exclusion criteria
Exclusion criteria: 1. Patients with chronic neurological or other physical illness 2. Suffering from any other psychiatric disorder other than major depressive disorder in their respective groups, as assessed by Mini International Neuropsychiatric Interview (MINI) screen 3. Persistent mood disorders (dysthymia) and other and unspecified depressions based on DSM 5 4. History of significant head trauma 5. Patients with alcohol or other substance abuse (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in scores of Hamilton Depression Rating Scale (HDRS)Timepoint: After first session and after 3 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in activation and connectivity seen on fNIRS & QEEG during resting state as well as activation state (in response to emotional tasks) scans and changes in BDNF levelsTimepoint: After first session and after 3 weeks | — |
Countries
India
Contacts
Public ContactRohit Verma
All India Institute of Medical Sciences
Outcome results
None listed