Role Of Ketamine in Treatment-Resistant Major Depressive Disorder And Its Effect on Suicidality
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2019
CompletedFirst Posted
Study publicly available on registry
September 24, 2019
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedMarch 5, 2025
March 1, 2025
1.1 years
September 22, 2019
March 1, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Ketamine group
ACTIVE COMPARATORThis group had ketamine
Placebo group
NO INTERVENTIONThis group had not take ketamine
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Presence of perceptual disturbance.
- History of sensitivity to ketamine.
- Refusal to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut university
Asyut, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Role Of Ketamine in treatment-Resistant Major Depressive Disorder And its Effect on Suicidality.
Study Record Dates
First Submitted
September 22, 2019
First Posted
September 24, 2019
Study Start
September 1, 2020
Primary Completion
October 1, 2021
Study Completion
October 1, 2021
Last Updated
March 5, 2025
Record last verified: 2025-03