Effectiveness of Ketamine Treatment for Three Consecutive Days in Depression

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.

Status Recruiting
Results Published No
Start date 01 September 2021
End date 31 July 2022
Phase Phase IV
Design Blinded
Type Interventional
Generation First
Participants 24
Sex All
Age 20- 99
Therapy Yes

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

Data attribution

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