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Cognitive Therapy to Sustain the Antidepressant Effects of Intravenous Ketamine in Treatment-resistant Depression

This study is not yet open for participant recruitment.
Verified January 2017 by Yale University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03027362
First Posted: January 23, 2017
Last Update Posted: January 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Yale University
  Purpose
The goals of this study are: 1) to investigate the efficacy of combining ketamine with intensive cognitive behavioral therapy (CBT) to sustain the antidepressant effects of ketamine; and 2) to determine ketamine's delayed effects on learning and memory, and to explore the relationship between any ketamine-induced changes in learning and memory and duration of antidepressant efficacy, with and without CBT augmentation. Subjects with a diagnosis of MDD who are treatment-resistant to at least 2 antidepressants and have chosen to pursue clinical ketamine treatment at Yale Psychiatric Hospital will be recruited for the study.

Condition Intervention
Depressive Disorder, Major Other: Cognitive behavioral therapy (CBT) and medication Other: Psychoeducation and medication

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Therapy to Sustain the Antidepressant Effects of Intravenous Ketamine in Treatment-resistant Depression: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Time to relapse of depression measured by the Montgomery-Asberg Depressive Rating Scale (MADRS) score. [ Time Frame: Enrollment to 17 week follow-up ]
    Relapse is defined as less than 50% improvement in MADRS compared to baseline MADRS score. The median time to relapse is the time at which the 50th percentile of participants relapses.


Secondary Outcome Measures:
  • Change in cognitive flexibility-working memory [ Time Frame: Before the first ketamine treatment and 24 hours following the last ketamine treatment. ]
    Measured by n-back task

  • Change in cognitive flexibility-executive function [ Time Frame: Before the first ketamine treatment and 24 hours following the last ketamine treatment. ]
    Measured by set shifting task (COGSTATE test)


Estimated Enrollment: 28
Study Start Date: January 2017
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive behavioral therapy (CBT) and medication
Following clinical ketamine treatment, the intervention includes sixteen CBT sessions over 14 weeks. In addition, standard of care medications for treatment of depression, will be prescribed by the principal investigator or by a psychiatrist unaffiliated with the trial. Participants will remain on the medication they were prescribed when they entered the study and will be expected not to adjust the medication unless clinically urgent.
Other: Cognitive behavioral therapy (CBT) and medication
Sixteen sessions over 14 weeks.
Active Comparator: Psychoeducation and medication
Following clinical ketamine treatment, the intervention includes psychoeducational sessions over 14 weeks.In addition, standard of care medications for treatment of depression, will be prescribed by the principal investigator or a by psychiatrist unaffiliated with the trial.
Other: Psychoeducation and medication

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Suffering from a major depressive episode based on Diagnostic and Statistical manual (DSM) 5 criteria and having failed one or more standard antidepressant treatments during the current episode
  • Hamilton Depression Rating Scale (17-HAM-D) score of 21 or more prior to ketamine treatment.
  • Planned clinical treatment with ketamine at Yale Psychiatric Hospital (YPH)
  • As the purpose of this study is to determine the feasibility and efficacy of CBT to sustain the antidepressant effects of ketamine, only those who achieve a clinical response (i.e., 50% reduction in depression symptoms, as measured by the Montgomery-Asberg Depressive Rating Scale (MADRS) will be eligible for randomization.
  • Patients must be treatment resistant to at least two drugs used to treat depression.

Exclusion Criteria:

  • Any Axis I or Axis II Disorder, which at screening is clinically predominant to their depressive episode or has been predominant to their depressive episode at any time within 6 months prior to screening
  • Active suicidal thoughts with a plan
  • Current or recent (<6 months ago) substance use disorder
  • Non-affective psychosis (such as schizophrenia or schizoaffective disorder)
  • Inability to speak English fluently
  • A clinically significant abnormality on the screening physical examination that might affect safety, study participation, or confound interpretation of study results
  • Dementia, delirium, or any other neurological or mental disease that might affect cognition or the ability to meaningfully participate in cognitive behavioral therapy (CBT).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03027362


Contacts
Contact: Samuel Wilkinson, MD : 203-764-9131 Samuel.wilkinson@yale.edu

Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Samuel Wilkinson, MD Yale University
  More Information

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03027362     History of Changes
Other Study ID Numbers: Wilkinson003
First Submitted: January 19, 2017
First Posted: January 23, 2017
Last Update Posted: January 23, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Ketamine
Antidepressive Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Psychotropic Drugs