Role Of Ketamine in Treatment-Resistant Major Depressive Disorder And Its Effect on Suicidality
Primary Purpose
Treatment Resistant Depression
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Ketamine
Sponsored by
About this trial
This is an interventional treatment trial for Treatment Resistant Depression
Eligibility Criteria
Inclusion Criteria:
- Patients fulfilling diagnostic criteria of treatment-resistant MDD.
- Presence of suicidal risk.
- No comorbid medical or neurological conditions.
- Age above 18 years old.
- Both gender.
- Informed written consent from the patient or his legitimate.
Exclusion Criteria:
- Presence of perceptual disturbance.
- History of sensitivity to ketamine.
- Refusal to participate in the study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Ketamine group
Placebo group
Arm Description
half of participants will take ketamine
the other half of participants will not take any drugs
Outcomes
Primary Outcome Measures
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.
Effect of Ketamine on Suicidality
finding out whether the onset of Ketamine antidepressant effect is associated with an improvement of suicidality in those patients
Secondary Outcome Measures
Full Information
NCT ID
NCT04101474
First Posted
September 22, 2019
Last Updated
September 25, 2019
Sponsor
Assiut University
1. Study Identification
Unique Protocol Identification Number
NCT04101474
Brief Title
Role Of Ketamine in Treatment-Resistant Major Depressive Disorder And Its Effect on Suicidality
Official Title
Role Of Ketamine in Treatment-Resistant Major Depressive Disorder And Its Effect on Suicidality
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2019 (Anticipated)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
February 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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:
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.
To find out whether the onset of Ketamine antidepressant effect is associated with an improvement of suicidality in those patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ketamine group
Arm Type
Active Comparator
Arm Description
half of participants will take ketamine
Arm Title
Placebo group
Arm Type
No Intervention
Arm Description
the other half of participants will not take any drugs
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
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
Primary Outcome Measure Information:
Title
Role of Ketamine as Antidepressant
Description
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.
Time Frame
1 year
Title
Effect of Ketamine on Suicidality
Description
finding out whether the onset of Ketamine antidepressant effect is associated with an improvement of suicidality in those patients
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients fulfilling diagnostic criteria of treatment-resistant MDD.
Presence of suicidal risk.
No comorbid medical or neurological conditions.
Age above 18 years old.
Both gender.
Informed written consent from the patient or his legitimate.
Exclusion Criteria:
Presence of perceptual disturbance.
History of sensitivity to ketamine.
Refusal to participate in the study.
12. IPD Sharing Statement
Learn more about this trial
Role Of Ketamine in Treatment-Resistant Major Depressive Disorder And Its Effect on Suicidality
We'll reach out to this number within 24 hrs