Effectiveness of Ketamine Treatment for Three Consecutive Days in Depression

Study Overview
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Brief Summary
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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.

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

Conditions
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Depression

Intervention / Treatment
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* Drug: Ketamine Hydrochloride
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine<br> | Drug: Ketamine Hydrochloride<br>* Ketamine hydrochloride 0.5 mg/kg intravenous administer in 40 minutes per day for 3 consecutive days<br>|
| Placebo Comparator: Midazolam<br> | Drug: Midazolam<br>* Midazolam<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery-Åsberg Depression Rating Scale (MADRS) | decrease more than 50% of scale from baseline is defined as remission | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dissociation | The dissociative experiences measure, Oxford (DEMO) | immediately after administraion | 
| health questionnaire | The 5-level EQ-5D version (EQ-5D-5L) | 1 month |