This study aims to openly test the long-term safety, tolerability and effectiveness of repeated administration of IM/SC ketamine for treatment resistant MDD.
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
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Repeated doses of IM/SC ketamine up to 3 times a week
Hadassah Hebrew University Medical Center
Jerusalem, Israel
RECRUITINGMADRS
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
Time frame: 1 month into treatment through study completion
MADRS
The change in MADRS score at 3 months compared to baseline.
Time frame: 3 months into treatment
QIDS-SR, Clinical Global Impressions - Improvement
The change in QIDS-SR and CGI scores at 1, 3 and 6 months compared to baseline.
Time frame: along 6 months
Average time in remission
Average time in remission.
Time frame: along 6 months
NeuroTrax computerized cognitive battery
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.
Time frame: along 6 months
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