This double-blind, placebo-controlled trial (n=24) aims to evaluate the effectiveness of ketamine treatment compared to midazolam over three consecutive days in patients with difficult-to-treat depression.
Conducted by Mahidol University, Thailand, the study includes participants over 20 years old diagnosed with depression (MADRS >= 25) who have not responded adequately to previous antidepressant treatments and psychotherapy. Participants will receive either ketamine (0.5 mg/kg IV drip in 40 minutes) or midazolam (0.045 mg/kg IV drip in 40 minutes) once daily for three days.
The primary outcome measures include changes in MADRS scores, vital signs, dissociative symptoms, CGI, and quality of life (EQ-5D-5L) during and after treatment. Exclusion criteria involve various medical conditions and substance use disorders. The study started in September 2021 and is estimated to be completed by July 2022.
Trial Details
Inclusion criteria: 1. patient over 20 years old with depression diagnosed by a psychiatrist and MADRS >= 25 scores; 2. failed to improve by at least optimal dosage of two antidepressants for four weeks and one psychotherapy. Patients and outcome assessors will be blinded from intervention the patients have. Participants will be randomized into two groups that are intervention (ketamine 0.5 mg/kg IV drip in 40 minutes) and control (midazolam 0.045 mg/kg IV drip in 40 minutes) groups. Participants will administer ketamine/midazolam once daily for three consecutive days. They will be evaluate MADRS changing, vital signs, dissociative symptoms, CGI, and quality of life (EQ-5D-5L) during the treatment, at 1 week and 4 weeks after treatment completion.Trial Number NCT05026203