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.
Role Of Ketamine in Treatment-Resistant Major Depressive Disorder And Its Effect on Suicidality
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.
Intervention / Treatment
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Ketamine (DRUG)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
Condition or Disease
- Treatment Resistant Depression
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Unknown status |
| Study results: | No Results Available |
| Age: | 18 Years and older (Adult, Older Adult) |
| Enrollment: | 30 (ESTIMATED) |
| Funded by: | Other |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
Masking |
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Clinical Trial Dates
| Start date: | Dec 01, 2019 | ESTIMATED |
|---|---|---|
| Primary Completion: | Dec 01, 2020 | ESTIMATED |
| Completion Date: | Feb 01, 2021 | ESTIMATED |
| Study First Posted: | Sep 24, 2019 | ACTUAL |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Sep 25, 2019 |
Sponsors / Collaborators
Lead Sponsor:
Assiut University
Responsible Party:
N/A
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.
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.
Participant Groups
-
half of participants will take ketamine
-
the other half of participants will not take any drugs
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
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.
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.
Primary Outcomes
-
-
finding out whether the onset of Ketamine antidepressant effect is associated with an improvement of suicidality in those patients
More Details
| NCT Number: | NCT04101474 |
|---|---|
| Other IDs: | Ketamine with TRD |
| Study URL: | https://clinicaltrials.gov/study/NCT04101474 |
Last updated: Sep 29, 2023