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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment Resistant Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

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

    First Posted
    September 22, 2019
    Last Updated
    September 25, 2019
    Sponsor
    Assiut University
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    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

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

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