Ketamine for Treatment Resistant MDD

Depressive Disorder, Major Clinical Trial

Official title:

Ketamine for Treatment Resistant Depression - A Long Term Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04021433
• Other study ID #: 58717-HMO-CTIL
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: June 2019
• Source: Hadassah Medical Organization
• Contact: Moshe Isserles, MD
• Phone: 00972 2 6777184
• Email: moshay[@]hadassah.org.il
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 30, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Drug:
• Ketamine
Repeated doses of IM/SC ketamine up to 3 times a week

Locations

Country	Name	City	State
Israel	Hadassah Hebrew University Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MADRS	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	1 month into treatment through study completion
Secondary	MADRS	The change in MADRS score at 3 months compared to baseline.	3 months into treatment
Secondary	QIDS-SR, Clinical Global Impressions - Improvement	The change in QIDS-SR and CGI scores at 1, 3 and 6 months compared to baseline.	along 6 months
Secondary	Average time in remission	Average time in remission.	along 6 months
Secondary	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.	along 6 months