Ketamine for Treatment Resistant MDD

This study aims to openly test the long-term safety, tolerability and effectiveness of repeated administration of IM/SC ketamine for treatment resistant MDD.

Topic Depression
Compound Ketamine
Country Israel
Visit trial
Status Unknown status
Results Published No
Start date 01 September 2018
End date 30 December 2020
Chance of happening 0%
Phase Not Applicable
Design Open
Type Interventional
Generation First
Participants 20
Sex All
Age 18- 65
Therapy No

Trial Details

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.

NCT Number NCT04021433

Sponsors & Collaborators

Hadassah Medical Organization
This company doesn't have a full profile yet, it is linked to a clinical trial.

Measures Used

Clinical Global Impression - Improvement Scale
The Clinical Global Impression - Improvement Scale (CGI-I) is a standardized assessment scale for determining the effects of mental health treatment among psychiatric patients.

Quick Inventory of Depressive Symptomatology
The Quick Inventory of Depressive Symptomatology (Self-Report) (QIDS-SR16) is a self-report tool designed to screen for depression and measure changes in the severity of symptoms.

Data attribution

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