Health Condition 1: F33- Major depressive disorder, recurrent Health Condition 2: F32- Major depressive disorder, singleepisode
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: Nil: Nil
Intervention4: Nil: Nil
Sponsors
Dr Ishaan Mittal
Eligibility
Inclusion criteria
Inclusion criteria: All genders aged 18 65 years. (Minors will not be included) Diagnosed with single episode or recurrent depressive disorder based on ICD-11 criteria (as diagnosed by the consultant) Moderate to severe depression without psychotic symptoms Willing and able to provide written informed consent and agrees to regular in-person/telephonic follow-up Able to speak Kannada or English
Exclusion criteria
Exclusion criteria: History of substance dependence except Nicotine dependence syndrome Bipolar disorder current depressive episode or in remission Medical conditions (e g, uncontrolled hypertension - SBP more than 150 or DBP more than 100, aortic dissection, stroke, arrhythmia, Uncontrolled asthma, renal or liver failure, prior allergy to ketamine) Pregnancy or lactation Patients who are unwilling to take part in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the improvement in depressive symptoms as measured by Hamilton depression rating scale (HAM-D) after last session of oral ketamine.Timepoint: Baseline and after last session of oral ketamine | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the improvement in depressive symptoms as measured by Beck s depression inventory -II (BDI-II) serially over treatment course. 2. To evaluate the improvement in suicidal ideations as measured by Beck s scale for suicidal ideation (BSS) after the last session of oral ketamine. 3. To evaluate the improvement in anhedonia as measured by Self-Assessment Anhedonia Scale (SAAS) after last session of oral ketamine. Timepoint: Baseline, 2nd week, 3rd week, and last session of oral ketamine;To assess the safety and tolerability of domiciliary oral ketamine by using semi-structured questions at the treatment endpoint.Timepoint: At the treatment endpoint;To evaluate cardiovascular changes in the first session of oral ketamine therapy and its association with effectivenessTimepoint: During 1st session | — |
Countries
India
Contacts
Public ContactDr Abhiram PN
Department of Psychiatry, Kasturba Medical College, Manipal
Outcome results
None listed