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.

Study Overview

• Status: Unknown
• Conditions: Treatment Resistant Depression
• Intervention / Treatment: Drug: Ketamine

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 (Anticipated): 30
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Ketamine group; half of participants will take 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; the other half of participants will not take any drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2019
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): February 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): September 27, 2019
• Last Update Submitted That Met QC Criteria: September 25, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• 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