Ketamine for Treatment Resistant MDD

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04021433
Study type	Interventional
Source	Hadassah Medical Organization
Contact	Moshe Isserles, MD
Phone	00972 2 6777184
Email	moshay@hadassah.org.il
Status	Recruiting
Phase	N/A
Start date	September 1, 2018
Completion date	December 30, 2020

View Details

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