Ketamine for Treatment Resistant MDD

Ketamine for Treatment Resistant Depression - A Long Term Feasibility Study

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

Study Overview

• Status: Unknown
• Conditions: Depressive Disorder, Major
• Intervention / Treatment: Drug: Ketamine

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hadas Lamberg, PhD; Phone Number: 00 972 2 6777572; Email: lhadas@hadassah.org.il
• Study Contact Backup: Name: Moshe Isserles, MD; Phone Number: 00972 2 6777184; Email: moshay@hadassah.org.il

Study Locations

• Israel
  • Jerusalem, Israel
    • Recruiting
    • Hadassah Hebrew University Medical Center
    • Contact: Isserles Moshe, MD, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MDD; Treatment resistant patients will be treated with multiple doses of IM/SC ketamine [dose range 0.3-1.5mg/kg]	Drug: Ketamine; Repeated doses of IM/SC ketamine up to 3 times a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
MADRS	The change in MADRS score at 3 months compared to baseline.	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.	along 6 months
Average time in remission	Average time in remission.	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.	along 6 months

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: July 10, 2019
• First Submitted That Met QC Criteria: July 15, 2019
• First Posted (Actual): July 16, 2019

Study Record Updates

• Last Update Posted (Actual): July 16, 2019
• Last Update Submitted That Met QC Criteria: July 15, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: 58717-HMO-CTIL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No