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Effectiveness of Ketamine Treatment for Three Consecutive Days in Depression

Primary Purpose

Depression

Status
Recruiting
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Ketamine Hydrochloride
Midazolam
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Keerati PattanaseriRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ketamine

Midazolam

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

dissociation
The dissociative experiences measure, Oxford (DEMO)
health questionnaire
The 5-level EQ-5D version (EQ-5D-5L)

Full Information

First Posted
August 24, 2021
Last Updated
May 15, 2022
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT05026203
Brief Title
Effectiveness of Ketamine Treatment for Three Consecutive Days in Depression
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
July 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketamine
Arm Type
Experimental
Arm Title
Midazolam
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ketamine Hydrochloride
Intervention Description
Ketamine hydrochloride 0.5 mg/kg intravenous administer in 40 minutes per day for 3 consecutive days
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
Midazolam
Primary Outcome Measure Information:
Title
Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
decrease more than 50% of scale from baseline is defined as remission
Time Frame
1 month
Secondary Outcome Measure Information:
Title
dissociation
Description
The dissociative experiences measure, Oxford (DEMO)
Time Frame
immediately after administraion
Title
health questionnaire
Description
The 5-level EQ-5D version (EQ-5D-5L)
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Keerati Pattanaseri, MD
Phone
024192667
Email
keerati.pat@mahidol.ac.th
Facility Information:
Facility Name
Keerati Pattanaseri
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keerati Pattanaseri
Phone
024192667
Email
keerati.pat@mahidol.ac.th

12. IPD Sharing Statement

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Effectiveness of Ketamine Treatment for Three Consecutive Days in Depression

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