NCT05026203

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4 depression

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 30, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

11 months

First QC Date

August 24, 2021

Last Update Submit

March 12, 2024

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • Montgomery-Åsberg Depression Rating Scale (MADRS)

    decrease more than 50% of scale from baseline is defined as remission

    1 month

Secondary Outcomes (2)

  • dissociation

    immediately after administraion

  • health questionnaire

    1 month

Study Arms (2)

Ketamine

EXPERIMENTAL
Drug: Ketamine Hydrochloride

Midazolam

PLACEBO COMPARATOR
Drug: Midazolam

Interventions

Ketamine HydrochlorideDRUG

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

Ketamine
MidazolamDRUG

Midazolam

Midazolam

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Keerati Pattanaseri

Bangkok, 10700, Thailand

Location

Related Publications (1)

  • Pattanaseri K, Lortrakul J, Jaisin K, Srifuengfung M, Sa-Nguanpanich N, Viravan N, Pariwatcharakul P, Makarasara W, Ratta-Apha W. A randomized controlled pilot study of daily intravenous ketamine over three days for treatment-resistant depression. BMC Psychiatry. 2024 Jul 18;24(1):512. doi: 10.1186/s12888-024-05951-5.

    PMID: 39026266DERIVED

MeSH Terms

Conditions

Depression

Interventions

KetamineMidazolam

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consualtant psychiatrist

Study Record Dates

First Submitted

August 24, 2021

First Posted

August 30, 2021

Study Start

September 1, 2021

Primary Completion

July 31, 2022

Study Completion

November 30, 2023

Last Updated

March 15, 2024

Record last verified: 2024-03

Locations

TH(1)