Ketamine for Treatment Resistant MDD

Not Applicable

• Conditions: Depressive Disorder, Major
• Interventions: Drug: Ketamine

• Registration Number: NCT04021433
• Lead Sponsor: Hadassah Medical Organization

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 Timeline

• Study Start: 2018-09-01
• Status Verified: 2019-06
• Study First Submitted: 2019-07-10
• Study First Submitted QC: 2019-07-15
• Last Update Submitted: 2019-07-15
• Study First Posted: 2019-07-16
• Last Update Posted: 2019-07-16
• Primary Completion: 2020-10-01
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MDD	Ketamine	Treatment resistant patients will be treated with multiple doses of IM/SC ketamine \[dose range 0.3-1.5mg/kg\]

Primary Outcome Measures

Name	Time	Method
MADRS	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

Secondary Outcome Measures

Name	Time	Method
MADRS	3 months into treatment	The change in MADRS score at 3 months compared to baseline.
QIDS-SR, Clinical Global Impressions - Improvement	along 6 months	The change in QIDS-SR and CGI scores at 1, 3 and 6 months compared to baseline.
Average time in remission	along 6 months	Average time in remission.
NeuroTrax computerized cognitive battery	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.

Trial Locations

Locations (1)

Hadassah Hebrew University Medical Center; 🇮🇱 Jerusalem, Israel