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CompletedPhase 4

Effectiveness of Ketamine Treatment for Three Consecutive Days in Depression

NCT05026203 · Mahidol University

Closed to entry
Status
Not accepting participants
Phase 4
Phase
24
Target enrolment
1
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Montgomery-Åsberg Depression Rating Scale (MADRS)

    Measured over 1 month

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

20 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * over 20 years old * depression was diagnosed by a psychiatrist and having MADRS \>= 25 * depression treated with 2 optimal dosage of antidepressants for 4 weeks and one psychotherapy * stable dosage of current medications for 4 weeks * fluently Thai Exclusion Criteria: * secondary depression * PTSD * current pregnancy * history of increased intracranial hemorrhage, increased intracranial pressure, severe head injury, abnormal thyroid function, angina, heart failure, arrhythmia, aneurysm, uncontrolled hypertension, chronic lower tract respiratory disease, myasthenia gravis, glaucoma, dementia, acute porphyria, or cystitic (within 3 months prior to recruitment) * allergy to ketamine or midazolam * history of substance use disorder within 1 year prior to recruitment * history of psychosis within 3 months * history of bipolar disorder * BMI over 35 * frail medical condition * currently ECT or TMS

Where

1 study site

FacilityCityRegionCountry
Keerati PattanaseriBangkok—Thailand

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05026203 on ClinicalTrials.gov →

Last updated in the registry 2024-03-15. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Indication