Ketamine Therapy Plus or Minus Naltrexone in Treatment-Resistant Depression (TRD)

2016-09-22 20:53:26 | BioPortfolio


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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment






Not yet recruiting


Stanford University

Results (where available)

View Results


Published on BioPortfolio: 2016-09-22T20:53:26-0400

Clinical Trials [897 Associated Clinical Trials listed on BioPortfolio]

Naltrexone & SSRI in Alcoholics With Depression/PTSD

The purpose of this study is to evaluate the efficacy of naltrexone in combination with an SSRI to reduce alcohol consumption in alcoholic patients with comorbid PTSD and depression. We h...

Opiate Dependence: Combined Naltrexone/Behavior Therapy - 1

The overall goal of this research project is to test a newly developed behavioral therapy to enhance the efficacy of naltrexone maintenance and make it a viable alternative to methadone ma...

A Study of Naltrexone SR/ Bupropion SR in Overweight or Obese Subjects With Major Depression

The purpose of this study is to determine whether a combination of naltrexone SR and bupropion SR is safe and effective in the treatment of major depression in overweight or obese subjects...

Naltrexone Implants as Relapse Prevention

The purpose of this clinical trial is to study the efficacy and safety of naltrexone implants as relapse prevention for patients that are completing treatment for opiate addiction in inp...

Sertraline for Alcohol Dependence and Depression

This study will examine depressed alcoholic outpatients to assess whether combining naltrexone (Revia) and sertraline (Zoloft) will result in greater reductions in both drinking and depres...

PubMed Articles [2438 Associated PubMed Articles listed on BioPortfolio]

Lithium attenuated the behavioral despair induced by acute neurogenic stress through blockade of opioid receptors in mice.

Major depressive disorder is disease with high rate of morbidity and mortality. Stressful events lead to depression and they can be used as a model of depression in rodents. In this study we aimed to ...

A Delayed Injection-Site Reaction in a Patient Receiving Extended Release Naltrexone.

Pharmacotherapy, such as oral naltrexone, has proven effective in treating alcohol use disorder, though medication adherence has presented challenges. While a formulation of extended-release naltrexon...

Comparing Nalmefene and Naltrexone in Alcohol Dependence: Are there any Differences? Results from an Indirect Meta-analysis.

Background: The mu-opioid antagonist naltrexone is one of the few approved pharmacotherapies for the treatment of alcohol dependence. Recently, the mu-opioid antagonist and partial kappa agonist nalme...

Gender differences in treatment and clinical characteristics among patients receiving extended release naltrexone.

Further research is needed to investigate real-world acceptability of extended release naltrexone (XR-NTX) for alcohol and opioid use disorders, and potential gender differences.

Interest in Extended Release Naltrexone among Opioid Users.

Treatment for addiction to illicit opioids has, thus far, been limited to 2 main approaches: maintaining physical dependence by administering opioids medically and medication-free abstinence with psyc...

Medical and Biotech [MESH] Definitions

Derivative of noroxymorphone that is the N-cyclopropylmethyl congener of NALOXONE. It is a narcotic antagonist that is effective orally, longer lasting and more potent than naloxone, and has been proposed for the treatment of heroin addiction. The FDA has approved naltrexone for the treatment of alcohol dependence.

Decompression external to the body, most often the slow lessening of external pressure on the whole body (especially in caisson workers, deep sea divers, and persons who ascend to great heights) to prevent DECOMPRESSION SICKNESS. It includes also sudden accidental decompression, but not surgical (local) decompression or decompression applied through body openings.

Depression in POSTPARTUM WOMEN, usually within four weeks after giving birth (PARTURITION). The degree of depression ranges from mild transient depression to neurotic or psychotic depressive disorders. (From DSM-IV, p386)

Depressive states usually of moderate intensity in contrast with major depression present in neurotic and psychotic disorders.

The prototypical tricyclic antidepressant. It has been used in major depression, dysthymia, bipolar depression, attention-deficit disorders, agoraphobia, and panic disorders. It has less sedative effect than some other members of this therapeutic group.

More From BioPortfolio on "Ketamine Therapy Plus or Minus Naltrexone in Treatment-Resistant Depression (TRD)"

Quick Search

Relevant Topic

Psychiatry is the study of mental disorders and their diagnosis, management and prevention.  Conditions include schizophrenia, severe depression and panic disorders among others. There are pharmaceutical treatments as well as other therapies to help...

Searches Linking to this Trial