Patients with depression are acutely distressed, often suicidal, and unable to meet the demands of everyday life. If proven effective in a rigorously conducted multicenter randomized controlled trial (RCT), oral ketamine would provide an affordable and scalable, intervention suitable for integration into routine psychiatric services.This study will establish an indigenous, cost-effective therapeutic strategy that could improve accessibility, hasten therapeutic response, and inform treatment guidelines, if found to be safe and effective.
Consenting adult outpatients or inpatients with at least moderately severe major depressive episode (MDE), denoted by HAM- D more than or equal to 20, associated with major depressive disorder or bipolar disorder, with diagnosis confirmed using a structured diagnostic interview.
Patients with co-morbid obsessive-compulsive disorder or intellectual disability disorder or co-morbid substance dependence other than nicotine or patients concurrently receiving neuromodulation treatments or those with psychotic symptoms. Patients with current or ongoing suicide risk, such as active suicidal ideation with a specific plan or some intent in the last 3 days, will be excluded if they are treated as outpatients. Patients in whom, in the subjective opinion of the PI, the MDE symptoms appear to be significantly driven by acute life events or circumstances. Patients with abnormalities of concern detected in the electrocardiogram, or with uncontrolled hypertension or those with ongoing pregnancy or lactation
Parallel
Oral ketamine
DrugNine sessions of oral ketamine
Oral midazolam
DrugNine sessions of oral midazolam
Hamilton Depression Rating Scale (HAM-D)
Endpoint HAM-D scores. Minimum 0 and maximum 52. Higher scores denote worse outcomes.
Hamilton Depression Rating Scale (HAM-D)
Endpoint HAM-D scores. Minimum 0 and maximum 52. Higher scores denote worse outcomes.
Montgomery-Asberg Depression Rating Scale (MADRS)
Endpoint MADRS scores. Minimum 0 and maximum 60. Higher scores denote worse outcomes.
Patient Health Questionnaire (PHQ)-9
Endpoint PHQ scores. Minimum 0 and maximum 27. Higher scores denote worse outcomes.
Hamilton Depression Rating Scale (HAM-D)/Montgomery-Asberg Depression Rating Scale (MADRS)
Response and remisssion rates. HAM-D-Minimum 0 and maximum 52. MADRS-Minimum 0 and maximum 60.For both scales, higher scores denote worse outcomes.
Click on the lead sponsor to view all of their trials.
Jawaharlal Institute of Postgraduate Medical Education & Research
Lead sponsor
Indian Council of Medical Research
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
