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OpenTrials
Completed

NCT Number: NCT05026203

Effectiveness of Ketamine Treatment for Three Consecutive Days in Depression

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Keerati Pattanaseri

Bangkok, 10700, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketamine Hydrochloride

Drug

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

midazolam

Drug

Midazolam

Primary outcomes

  1. Montgomery-Åsberg Depression Rating Scale (MADRS)

    Time frame: 1 month

    decrease more than 50% of scale from baseline is defined as remission

Secondary outcomes

  1. dissociation

    Time frame: immediately after administraion

    The dissociative experiences measure, Oxford (DEMO)

  2. health questionnaire

    Time frame: 1 month

    The 5-level EQ-5D version (EQ-5D-5L)

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Effectiveness of Ketamine Treatment in Difficult-to-treat Depression Comparing With Midazolam: a Double-blind Randomized Controlled Trial and Its Cost Effectiveness Analysis

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Aug 30, 2021
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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