Role Of Ketamine in Treatment-Resistant Major Depressive Disorder And Its Effect on Suicidality

March 1, 2025 updated by: G.A. Khedr, Assiut University
In this study we will assess the effect of Ketamine infusion on depressive symptoms and in particular its effect on Suicidal behavior, ideation and thoughts in patients with treatment- resistant MDD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A Twice repetition of IV infusion of 0.5 mg/kg of ketamine produces an antidepressant response in individuals with treatment-resistant MDD

The work aims to:

  1. To assess the onset of action and degree of improvement and the duration of antidepressant effect of ketamine in a sample of patients with treatment -resistant major depressive disorder.
  2. To find out whether the onset of Ketamine antidepressant effect is associated with an improvement of suicidality in those patients.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients fulfilling diagnostic criteria of treatment-resistant MDD.
  2. Presence of suicidal risk.
  3. No comorbid medical or neurological conditions.
  4. Age above 18 years old.
  5. Both gender.
  6. Informed written consent from the patient or his legitimate.

Exclusion Criteria:

  1. Presence of perceptual disturbance.
  2. History of sensitivity to ketamine.
  3. Refusal to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ketamine group
This group had ketamine
Drug: Ketamine
Ketamine is a high-affinity, noncompetitive N-methyl-D- aspartate (NMDA) glutamate receptor antagonist it has been used in anesthesiology for more than 50 years the time course of antidepressant response to ketamine is characterized by an initial reduction in depressive symptoms within 2 h
No Intervention: Placebo group
This group had not take ketamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Role of Ketamine as Antidepressant
Time Frame: 1 year
the onset of action and degree of improvement and the duration of antidepressant effect of ketamine in a sample of patients with treatment -resistant major depressive disorder.
1 year
Effect of Ketamine on Suicidality
Time Frame: 1 year
finding out whether the onset of Ketamine antidepressant effect is associated with an improvement of suicidality in those patients
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

October 1, 2021

Study Completion (Actual)

October 1, 2021

Study Registration Dates

First Submitted

September 22, 2019

First Submitted That Met QC Criteria

September 23, 2019

First Posted (Actual)

September 24, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 1, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ketamine with TRD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Treatment Resistant Depression

Clinical Trials on Ketamine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe