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Completed

NCT Number: NCT03027362

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

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.

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Key information

Conditions

Depressive Disorder, Major Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Cognitive behavioral therapy (CBT) and medication

Other

Sixteen sessions over 14 weeks.

Psychoeducation and medication

Other

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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)

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

Cognitive Therapy to Sustain the Antidepressant Effects of Intravenous Ketamine in Treatment-resistant Depression: a Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jan 23, 2017
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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