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

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ClinicalTrials.gov Identifier: NCT04101474
Recruitment Status : Unknown
Verified September 2019 by G.A. Khedr, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : September 24, 2019
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
G.A. Khedr, Assiut University

Tracking Information
First Submitted Date  ICMJE September 22, 2019
First Posted Date  ICMJE September 24, 2019
Last Update Posted Date September 27, 2019
Estimated Study Start Date  ICMJE December 1, 2019
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2019)
  • Role of Ketamine as Antidepressant [ Time Frame: 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 [ Time Frame: 1 year ]
    finding out whether the onset of Ketamine antidepressant effect is associated with an improvement of suicidality in those patients
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Role Of Ketamine in Treatment-Resistant Major Depressive Disorder And Its Effect on Suicidality
Official Title  ICMJE 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Treatment Resistant Depression
Intervention  ICMJE Drug: Ketamine
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
Study Arms  ICMJE
  • Active Comparator: Ketamine group
    half of participants will take ketamine
    Intervention: Drug: Ketamine
  • No Intervention: Placebo group
    the other half of participants will not take any drugs
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 23, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2021
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04101474
Other Study ID Numbers  ICMJE Ketamine with TRD
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party G.A. Khedr, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assiut University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP