drugset / Trial / NCT05026203

Effectiveness of Ketamine Treatment for Three Consecutive Days in Depression

NCT05026203 ↗

Phase 4 Completed 24 enrolled Mahidol University
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2021-09-01
Primary completion
2022-07-31
Completion
2023-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketamine Small molecule 0.5 mg/kg Intravenous

Indications