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

Assiut University

Status: Completed

Conditions: Treatment Resistant Depression

Treatments: Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT04101474

Ketamine with TRD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 2 patient groups

Ketamine group

Active Comparator group

Description:

This group had ketamine

Treatment:

Drug: Ketamine

Placebo group

No Intervention group

Description:

This group had not take ketamine