Effectiveness of Ketamine Treatment for Three Consecutive Days in Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2023-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Using a Low Dose of Ketamine vs. Active Placebo in Treating Severe Depression and Suicide

NCT03666390

Major Depressive Disorder

UNKNOWN NA

Ketamine As an Adjunctive Therapy for Major Depression (2)

NCT04939649

Major Depressive Episode Unipolar Depression Bipolar Depression

COMPLETED PHASE3

Efficacy of Repeated Ketamine Infusions for Treatment-resistant Depression

NCT02360280

Treatment-resistant Depression

COMPLETED PHASE2

Low-dose Ketamine Infusion Among Adolescents With Treatment-resistant Depression

NCT05045378

Treatment-resistant Depression Major Depressive Disorder

COMPLETED PHASE4

Ketamine as an Adjunctive Therapy for Major Depression

NCT03256162

Major Depressive Episode Unipolar Depression Bipolar Depression

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ketamine

Group Type EXPERIMENTAL

Ketamine Hydrochloride

Intervention Type DRUG

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

Midazolam

Group Type PLACEBO_COMPARATOR

Midazolam

Intervention Type DRUG

Midazolam

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ketamine Hydrochloride

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

Intervention Type DRUG

Midazolam

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No