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Completed

NCT Number: NCT04101474

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

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.

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Key information

Conditions

Treatment Resistant Depression Depressive Disorder Depressive Disorder, Treatment-Resistant Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut university

Asyut, Egypt

About this study

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:

  • 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.
  • To find out whether the onset of Ketamine antidepressant effect is associated with an improvement of suicidality in those patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Presence of perceptual disturbance.
  • History of sensitivity to ketamine.
  • Refusal to participate in the study.

Treatment and study plan

ketamine

Drug

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

Primary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 24, 2019
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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