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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05026203
Other study ID # 109/2564(IRB1)
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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