Health Condition 1: F322- Major depressive disorder, singleepisode, severe without psychotic features
Conditions
Interventions
Intervention1: Injection Ketamine: Injection Ketamine 0.5ml/kg body weight infusion over 40 minutes,six infusions over 2 weeks
Control Intervention1: Modified Electroconvulsive Therapy: six sessions o
Sponsors
Central Institute of Psychiatry Ranchi
Eligibility
Inclusion criteria
Inclusion criteria: â?ª Patients fulfilling ICD 10- DCR diagnostic criteria for â??unipolar(single or recurrent) non-psychotic depressive episodeâ?? â?ª Patients who are drug naïve or drug free for 2 weeks on antidepressants or 4 weeks for fluoxetine. â?ª Patients giving written informed consent â?ª Patients with suicidal ideation and behaviors are evaluated using the BSI (score>=6 has been used as a cutoff threshold for clinically significant suicidal ideation according to literature).
Exclusion criteria
Exclusion criteria: â?ª Depressive episodes with psychotic symptoms. â?ª Any other major co-morbid psychiatric diagnosis and substance dependence excluding nicotine & caffeine â?ª Presence of an acute/unstable medical or neurological condition â?ª Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.scores on the Becks scale of suicidal ideation following ketamine infusions vs modified electroconvulsive therapy 2.levels of kynurenine pathway metabolites kynurenic acid(KYNA) , quinolinic acid (QUIN) and QUIN/KYNA ratio in blood following ketamine infusions vs modified electroconvulsive therapy.Timepoint: 1.before 1 hour and after 1 hour, 4 hours and 24 hours of each session for six sessions and after 4 weeks of last session of ketamine infusion/modified electroconvulsive therapy. 2.one day before and after third,sixth session and four weeks of last session of ketamine infusion/modified electroconvulsive therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Scores on the scales: MADRS, HAM-A, BPRS, C-SSRS, CADSS, CGI following ketamine infusions vs modified electroconvulsive therapy.Timepoint: 1.Before 1 hour and after 1 hour, 4 hours and 24 hours of each session for six sessions and after 4 weeks of last session of ketamine infusion/modified electroconvulsive therapy. | — |
Countries
India
Contacts
Public ContactDr Varun S Mehta
Central Institute of Psychiatry, Ranchi
Outcome results
None listed