Treatment Resistant Depression
Conditions
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.
Interventions
DRUGKetamine
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
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The Sequentially Numbered, Opaque, Sealed Envelope technique (Schulz and Grimes, 2002) was employed: the randomization group was listed on paper and preserved in an opaque sealed envelope with a serial number. When a patient agreed to participate, the pharmacy (care provider) opened the sealed envelope and assigned the patient to the appropriate treatment group on the morning of their first infusion.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Outcome results
None listed