Effectiveness of Ketamine Treatment for Three Consecutive Days in Depression

Phase 4

Completed

• Conditions: Depression
• Interventions: Drug: Ketamine Hydrochloride; Drug: Midazolam

• Registration Number: NCT05026203
• Lead Sponsor: Mahidol University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-24
• Study First Submitted QC: 2021-08-27
• Study First Posted: 2021-08-30
• Study Start: 2021-09-01
• Primary Completion: 2022-07-31
• Study Completion: 2023-11-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine	Ketamine Hydrochloride	-
Midazolam	Midazolam	-

Primary Outcome Measures

Name	Time	Method
Montgomery-Åsberg Depression Rating Scale (MADRS)	1 month	decrease more than 50% of scale from baseline is defined as remission

Secondary Outcome Measures

Name	Time	Method
health questionnaire	1 month	The 5-level EQ-5D version (EQ-5D-5L)
dissociation	immediately after administraion	The dissociative experiences measure, Oxford (DEMO)

Trial Locations

Locations (1)

Keerati Pattanaseri; 🇹🇭 Bangkok, Thailand