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Effectiveness of Ketamine Treatment for Three Consecutive Days in Depression

NCT05026203 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-03-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ketamine Hydrochloride

Ketamine hydrochloride 0.5 mg/kg intravenous administer in 40 minutes per day for 3 consecutive days

DRUG

Midazolam

Midazolam

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05026203 on ClinicalTrials.gov