Health Condition 1: F332- Major depressive disorder, recurrent severe without psychotic features Health Condition 2: F331- Major depressive disorder, recurrent, moderate Health Condition 3: F321- Major depressive disorder, singleepisode, moderate Health Condition 4: F322- Major depressive disorder, singleepisode, severe without psychotic features
Conditions
Interventions
Intervention1: Oral ketamine: Cases will have 6 sessions of fixed oral dose of Ketamine, 150 mg to be given twice weekly. Sessions will be given twice weekly for 3 weeks.
Control Intervention1: placeb
Sponsors
GMC RH Patiala
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged 18-65 years with Diagnostic and Statistical Manual-5 (DSM-5) diagnosis of major depressive episode without psychotic features. 2. Patients who will be medically stable . 3. Patients who have given written informed consent.
Exclusion criteria
Exclusion criteria: 1. History of chronic psychosis or drug induced psychosis of any kind. 2. Current DSM-5 diagnosis of drug abuse/dependence in the last six months and a negative drug screen at baseline. 3. Pregnant women, lactating mothers, surgically-sterile women or women who agree to continue using applicable birth control throughout the trial. All women of child-bearing potential must have a negative urine pregnancy test. 4. History of seizures, renal insufficiency or congestive heart failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It will be therapeutic response ââ?°Â¥ 50% decrease in severity on HAM-D and improvement on BSIS, CGI (Clinical Global impression).Timepoint: Baseline, before and after each placebo session on 3rd, 6th and 9th day; before and after each ketamine session at 12th, 15th, 18th day and at 2 weeks follow-up after last ketamine session. | — |
Secondary
| Measure | Time frame |
|---|---|
| It will be high risk adverse effect on ADR proforma. The perceptual and dissociative changes on Clinician- Administered Dissociative States Scale (CADSS) and Improvement on GAF (Global assessment of function) scale.Timepoint: Baseline, before and after each placebo session on 3rd, 6th and 9th day; before and after each ketamine session at 12th, 15th, 18th day and at 2 weeks follow-up after last ketamine session. | — |
Countries
India
Contacts
Public ContactDr Ramanpreet Kaur
Department of Psychiatry
Outcome results
None listed