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

Treatment Resistant Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04101474
• Other study ID #: Ketamine with TRD
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: December 1, 2019
• Est. completion date: February 1, 2021

Study information

• Verified date: September 2019
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: February 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Depressive Disorder, Treatment-Resistant
• Treatment Resistant Depression

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Role of Ketamine as Antidepressant	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
Primary	Effect of Ketamine on Suicidality	finding out whether the onset of Ketamine antidepressant effect is associated with an improvement of suicidality in those patients	1 year