Comparative efficacy of oral Ketamine vs. Electroconvulsive therapy in moderate to severe depression: A randomized controlled trial.

The proposed study aims to conduct a randomized, controlled, parallel-group clinical trial at the Department of Psychiatry, AIIMS, Bhubaneswar. The study will include patients diagnosed with Moderate and Severe Depressive episodes based on ICD 10 (DCR) and DSM 5 criteria, who meet all the specified inclusion and exclusion criteria.Randomization will be performed using computer-generated random numbers, with an allocation ratio of 1:1, to assign the patients into two treatment groups. Sociodemographic and clinical data of the patients will be collected using predetermined forms. Baseline assessments of the patients’ MADRS (Montgomery-Ã…sberg Depression Rating Scale) scores will be conducted, and the study will be blinded to the assessors. The experimental group will receive oral ketamine as the treatment, starting with a dosage of 150mg in the first session, followed by 150-175mg three times a week for a duration of 2 weeks. (22) (16)and the control group would receive bitemporal Electroconvulsive Therapy up to 3 times a week for 2 weeks. ECT is to be administered at the lowest dose that elicits a generalized seizure. Both groups treated with a fixed course of alternate day sessions thrice a week for 2 weeks (total 6 sessions). All outcome measures with assessed at baseline and at 1 week, 2 weeks, 3 weeks, and 6 weeks.

The two groups would be followed for 6 weeks, at the completion of which all the patients would be reassessed. The follow-up assessment would involve a re-evaluation of the MADRS and other assessments to see for any change. The data thus collected would be analysed, and compared within and in between the study groups and statistical tests would be applied for drawing conclusions.