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Ketamine for Treatment Resistant MDD

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ClinicalTrials.gov Identifier: NCT04021433
Recruitment Status : Recruiting
First Posted : July 16, 2019
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization

Tracking Information
First Submitted Date  ICMJE July 10, 2019
First Posted Date  ICMJE July 16, 2019
Last Update Posted Date July 16, 2019
Actual Study Start Date  ICMJE September 1, 2018
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2019)
MADRS [ Time Frame: 1 month into treatment through study completion ]
The change in the MDRS score at 1 month (5weeks evaluation) for the acute phase and at 6 months or end of study (for the maintenance phase) compared to baseline
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2019)
  • MADRS [ Time Frame: 3 months into treatment ]
    The change in MADRS score at 3 months compared to baseline.
  • QIDS-SR, Clinical Global Impressions - Improvement [ Time Frame: along 6 months ]
    The change in QIDS-SR and CGI scores at 1, 3 and 6 months compared to baseline.
  • Average time in remission [ Time Frame: along 6 months ]
    Average time in remission.
  • NeuroTrax computerized cognitive battery [ Time Frame: along 6 months ]
    Changes in cognitive function at 1 and 6 months [or at study end] as assessed by the NeuroTrax computerized cognitive battery compared to baseline. correlation between information processing speed and other cognitive domains at baseline and clinical outcomes.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine for Treatment Resistant MDD
Official Title  ICMJE Ketamine for Treatment Resistant Depression - A Long Term Feasibility Study
Brief Summary This study aims to openly test the long-term safety, tolerability and effectiveness of repeated administration of IM/SC ketamine for treatment resistant MDD.
Detailed Description

Major depression disorder (MDD) is a common psychiatric disorders with considerable impact on patients' quality of life, social and occupational function. MDD also significantly increase suicide rate. About a third of the patients with MDD suffer from moderate to severe symptoms that are fully or partially unresponsive to accepted pharmaco and / or psycho therapy. Ketamine is a widely used anesthetic. Multiple studies done over the recent years had shown its therapeutic effects in resistant depressive patients. Unlike regular antidepressants, ketamine exerts its effect within hours to few days which implies an alternative mechanism of action not fully studied. So far, there are only few reports on using repeated ketamine administration to maintain the antidepressant effect or on intra-muscular or sub-cutaneous application that can be safer and more tolerable than the intravenous route.

In the present study, the investigators aim to openly assess the safety, tolerability and effectiveness of repeated, individually tailored IM or SC ketamine for treatment resistant major depression. The investigators intend to explore questions regarding optimal dose, treatment frequency and duration. The investigators will also assess potential cognitive effects of long-term ketamine treatment and look for possible treatment outcome predictors using the Neurotrax computerized cognitive battery.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
open
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Depressive Disorder, Major
Intervention  ICMJE Drug: Ketamine
Repeated doses of IM/SC ketamine up to 3 times a week
Study Arms  ICMJE Experimental: MDD
Treatment resistant patients will be treated with multiple doses of IM/SC ketamine [dose range 0.3-1.5mg/kg]
Intervention: Drug: Ketamine
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 15, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2020
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosed with unipolar/bipolar depression with MADRS Score>= 20
  • Inadequate response to >= 3 adequate treatment trials [>=2 trials in the present episode]
  • If on psychopharmacological Tx, it should be stable since 4 weeks prior to enrollment
  • QTc WNL

Exclusion Criteria:

  • Hypersensitivity to ketamine
  • Other major psychiatric diagnosis
  • High suicidality
  • Unstable physical illness
  • S/P CVA / brain SOL
  • Pregnant or breast feeding women
  • Illicit drug/alcohol abuse during last year
  • History of ketamine abuse
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Moshe Isserles, MD 00972 2 6777184 moshay@hadassah.org.il
Contact: Hadas Lamberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04021433
Other Study ID Numbers  ICMJE 58717-HMO-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hadassah Medical Organization
Study Sponsor  ICMJE Hadassah Medical Organization
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hadassah Medical Organization
Verification Date June 2019

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