Depression Clinical Trial
Official title:
Double-Blind, Cross-Over Trial of Ketamine Therapy Plus or Minus Naltrexone in Treatment Resistant Depression (TRD)
The primary objective is to determine if the opioid properties of ketamine are responsible for its antidepressant effects. Since naltrexone can block opiate actions, the investigators will determine if naltrexone can effectively block ketamine's effects.
The primary goal is to determine if the antidepressant effects of Ketamine are mediated by an
opiate mechanism.
Primary Objective:
To determine if the opioid properties of Ketamine are responsible for it's antidepressant
effects by potentially blocking the antidepressant effects with a opioid antagonist
naltrexone.
We will measure this objective by looking at the response on a scale called the 6- item
Hamilton Rating Scale for Depression (HAM-D-6). Response is defined as a statistically
significant greater decrease on the overall score on this scale, post infusion.
Secondary Objective:
This includes comparing a scale called Clinician Administered Dissociative States Scale
(CADSS) on both of our patient groups, one group receiving Ketamine plus Naltrexone compared
to the other group receiving Ketamine plus placebeo, to determine if naltrexone has any
effect on CADSS as well as to determine if CADSS is associated with antidepressant response
Another secondary objective is to assess ketamine craving using the Visual Analog Craving
Scale for Ketamine (VASK), after infusion and determine if there is a change in level of
craving for the group that receives naltrexone.
Number of Subjects:
i) 30
ii) The subjects will be drawn from an outpatient sample of patients with MDD, diagnosed with
the use of the Structured Clinical Interview for DSM-IV Axis I Disorders(SCID-I/P), currently
on a stable, adequate dose of antidepressant therapy, as defined by the MGH ATRQ, for at
least 4 weeks or a history of intolerance to at least 2 antidepressant treatments.
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