Ketamine for Treatment Resistant MDD

NCT ID: NCT04021433

Last Updated: 2019-07-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2020-12-30

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.

Conditions

Depressive Disorder, Major

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MDD

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

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

Repeated doses of IM/SC ketamine up to 3 times a week

Interventions

Ketamine

Repeated doses of IM/SC ketamine up to 3 times a week

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hadassah Hebrew University Medical Center

Jerusalem, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Moshe Isserles, MD

Role: CONTACT

moshay@hadassah.org.il

00972 2 6777184

Hadas Lamberg, PhD

Role: CONTACT

lhadas@hadassah.org.il

00 972 2 6777572

Facility Contacts

Isserles Moshe, MD, MSc

Role: primary

Other Identifiers

58717-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id