Effectiveness of Ketamine Treatment for Three Consecutive Days in Depression

Sponsor

Mahidol University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05026203

Collaborator

(none)

Enrollment

Location

Arms

10.9

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression	Drug: Ketamine Hydrochloride Drug: Midazolam	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Jul 31, 2022

Anticipated Study Completion Date :

Jul 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ketamine	Drug: Ketamine Hydrochloride Ketamine hydrochloride 0.5 mg/kg intravenous administer in 40 minutes per day for 3 consecutive days
Placebo Comparator: Midazolam	Drug: Midazolam Midazolam

Arm

Intervention/Treatment

Experimental: Ketamine

Drug: Ketamine Hydrochloride

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

Placebo Comparator: Midazolam

Drug: Midazolam

Midazolam

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Keerati Pattanaseri	Bangkok		Thailand	10700

Sponsors and Collaborators

Mahidol University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Keerati Pattanaseri, Consualtant psychiatrist, Mahidol University

ClinicalTrials.gov Identifier:

NCT05026203

Other Study ID Numbers:

109/2564(IRB1)

First Posted:

Aug 30, 2021

Last Update Posted:

May 19, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of May 19, 2022