Ketamine in the Treatment of Depression
Information source: Columbia University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depressive Disorder
Intervention: Ketamine (Drug); Ketamine (Drug); Ketamine (Drug); Ketamine (Drug); Ketamine (Drug); Saline (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Columbia University Official(s) and/or principal investigator(s):
Matthew S. Milak, M.D., Principal Investigator, Affiliation: Columbia University
Summary
Depressed patients will be offered experimental treatment with a new, potentially
fast-acting antidepressant called ketamine while being scanned by an MRI to measure the
chemical effect of the drug. Ketamine will be given in a dose of 0. 0 (placebo), 0. 1, 0. 2,
0. 3, 0. 4, or 0. 5 mg/kg. If a patient does not respond to ketamine after the first infusion,
it may be because s/he received ketamine placebo or the dose of ketamine was too low. In
that case, an optional second scan and infusion of active ketamine (0. 5 mg/kg) will be
offered. This second scan will occur no later than weeks after the first scan/infusion (as
scheduling permits). There is no guarantee that the patient will respond to the second
ketamine infusion. Patients enrolled in the study are eligible for up to 6 months treatment
with their study psychiatrist after the ketamine infusion(s). During this time, patients
will be responsible for the cost of the conventional antidepressants but all doctors' visits
will be free of charge. Healthy Volunteers: Healthy controls will receive an infusion of
ketamine at a single dose (0. 5 mg/kg). Volunteers will only receive one MRI scan and
infusion.
Clinical Details
Official title: The Antidepressant Action of Ketamine: Brain Chemistry
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Ketamine Dose-Response Curve
Detailed description:
Major depressive disorder (MDD) is a common illness, affecting over 14 million American
adults each year. MDD is a leading cause of disability worldwide, and is responsible for
huge workplace and healthcare costs. The several week delay between onset of treatment and
improvement in MDD symptoms with currently available treatments further increases the burden
of the disorder. Shortening this delay is a major unmet challenge in the treatment of MDD.
Studies report that a single intravenous low dose of a drug called ketamine can bring about
substantial improvement in depression in hours, even in patients that have not improved with
other antidepressant treatments. Certain aspects of ketamine's drug action are fairly well
understood, but the question remains of how these properties relate to antidepressant
effect. Our preliminary data support the rapid antidepressant benefit from ketamine. The
investigators have used a scanner to measure the effects of ketamine on two major brain
chemical transmitters and found that it causes a significant increase (more than 60%) in
glutamate (Glu) and gamma aminobutyric acid (GABA) levels in the front of the brain. The
investigators hypothesize that this increase in Glu and GABA levels, is responsible for the
antidepressant action of the medication. Knowing how ketamine works could help to develop
better medications that can be used orally and used for maintenance of the improvement seen
with ketamine. The objective of the proposed dose finding study is to examine the
relationship between the ketamine-induced improvement of MDD and the Glu and GABA responses
to ketamine and to compare the Glu and GABA responses to ketamine in MDD and healthy
subjects to better understand the pathophysiology of MDD. To achieve these aims this the
investigators propose a randomized, placebo-controlled, double blind study with several
different doses of ketamine. The investigators will conduct MRI scans to measure Glu and
GABA before and during the ketamine treatment.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
INCLUSION CRITERIA:
1. Must be currently depressed
EXCLUSION CRITERIA:
1. No history of other major psychiatric illnesses
2. No history of drug abuse
Locations and Contacts
Columbia University/New York State Psychiatric Institute, New York, New York 10032, United States
Additional Information
Ketamine in the Treatment of Depression
Starting date: February 2012
Last updated: June 4, 2015
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