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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03027362
Recruitment Status : Completed
First Posted : January 23, 2017
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE January 19, 2017
First Posted Date  ICMJE January 23, 2017
Last Update Posted Date February 5, 2020
Actual Study Start Date  ICMJE January 2017
Actual Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2017)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive Therapy to Sustain the Antidepressant Effects of Intravenous Ketamine in Treatment-resistant Depression
Official Title  ICMJE Cognitive Therapy to Sustain the Antidepressant Effects of Intravenous Ketamine in Treatment-resistant Depression: a Randomized Controlled Trial
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Depressive Disorder, Major
Intervention  ICMJE
  • Other: Cognitive behavioral therapy (CBT) and medication
    Sixteen sessions over 14 weeks.
  • Other: Psychoeducation and medication
Study Arms  ICMJE
  • 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.
    Intervention: Other: Cognitive behavioral therapy (CBT) and medication
  • 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.
    Intervention: Other: Psychoeducation and medication
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 20, 2017)
28
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 15, 2020
Actual Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03027362
Other Study ID Numbers  ICMJE 1609018450
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Samuel Wilkinson, MD Yale University
PRS Account Yale University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP