Effectiveness of Ketamine Treatment for Three Consecutive Days in Depression

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05026203

Enrollment

Registered

2021-08-30

Start date

2021-09-01

Completion date

2023-11-30

Last updated

2024-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

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.

Interventions

DRUGKetamine Hydrochloride

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

DRUGMidazolam

Midazolam

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026