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

Not Applicable

Completed

• Conditions: Treatment Resistant Depression
• Interventions: Drug: Ketamine

• Registration Number: NCT04101474
• Lead Sponsor: Assiut University

Brief 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.

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 Timeline

• Study First Submitted: 2019-09-22
• Study First Submitted QC: 2019-09-23
• Study First Posted: 2019-09-24
• Study Start: 2020-09-01
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-01
• Last Update Posted: 2025-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine group	Ketamine	This group had ketamine

Primary Outcome Measures

Name	Time	Method
Role of Ketamine as Antidepressant	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.
Effect of Ketamine on Suicidality	1 year	finding out whether the onset of Ketamine antidepressant effect is associated with an improvement of suicidality in those patients

Trial Locations

Locations (1)

Assiut university; 🇪🇬 Assiut, Egypt