To study the therapeutic efficacy of oral ketamine in depression
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- It will be therapeutic response ≥ 50% decrease in severity on HAM-D and improvement on BSIS, CGI (Clinical Global impression).
Study Overview
Brief Summary
Depressive Disorder is a common mental Disorder. The aim of this study is to find the therapeutic efficacy of oral ketamine in Depressive Disorder. Depression will be diagnosed on Diagnostic and Stastical Manual for Mental Health (DSM-5). The total number of 30 patients of Depression will be taken and will be divided into two groups i.e. Group A (n=15) and Group B (n=15). Informed written valid consent will be taken. Patients will be assessed on Hamilton rating scale (HAM-D) for depressive symptoms and severity, suicidality on Beck’s Suicide Intent Scale (BSIS) . Global assessment of functioning (GAF) Scale will be used to rate social, occupational and psychological functioning of adults. The perceptual and dissociative changes will be assessed on Clinician Administrated Dissociative States Scale (CADSS).
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Male and female patients aged 18-65 years with Diagnostic and Statistical Manual-5 (DSM-5) diagnosis of major depressive episode without psychotic features.
- •Patients who will be medically stable .
- •Patients who have given written informed consent.
Exclusion Criteria
- •History of chronic psychosis or drug induced psychosis of any kind.
- •Current DSM-5 diagnosis of drug abuse/dependence in the last six months and a negative drug screen at baseline.
- •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.
- •History of seizures, renal insufficiency or congestive heart failure.
Outcomes
Primary Outcomes
It will be therapeutic response ≥ 50% decrease in severity on HAM-D and improvement on BSIS, CGI (Clinical Global impression).
Time Frame: 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 Outcomes
- 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.(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.)