Status:
UNKNOWN
Ketamine for Treatment Resistant MDD
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Depressive Disorder, Major
Eligibility:
All Genders
18-65 years
Phase:
NA
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04021433
Start Date
September 1 2018
End Date
December 30 2020
Last Update
July 16 2019
Active Locations (1)
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1
Hadassah Hebrew University Medical Center
Jerusalem, Israel