Therapeutic efficacy of oral ketamine in Depressio
- Conditions
- Health Condition 1: F332- Major depressive disorder, recurrent severe without psychotic featuresHealth Condition 2: F331- Major depressive disorder, recurrent, moderateHealth Condition 3: F321- Major depressive disorder, singleepisode, moderateHealth Condition 4: F322- Major depressive disorder, singleepisode, severe without psychotic features
- Registration Number
- CTRI/2021/09/036776
- Lead Sponsor
- GMC RH Patiala
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method It will be therapeutic response 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 Outcome Measures
Name Time Method 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.