Effectiveness of Ketamine Treatment for Three Consecutive Days in Depression

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05026203
• Other study ID #: 109/2564(IRB1)
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2021
• Est. completion date: November 30, 2023

Study information

• Verified date: March 2024
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 30, 2023
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• Ketamine Hydrochloride
Ketamine hydrochloride 0.5 mg/kg intravenous administer in 40 minutes per day for 3 consecutive days
• Midazolam
Midazolam

Locations

Country	Name	City	State
Thailand	Keerati Pattanaseri	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery-Åsberg Depression Rating Scale (MADRS)	decrease more than 50% of scale from baseline is defined as remission	1 month
Secondary	dissociation	The dissociative experiences measure, Oxford (DEMO)	immediately after administraion
Secondary	health questionnaire	The 5-level EQ-5D version (EQ-5D-5L)	1 month