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Cognitive Therapy to Sustain the Antidepressant Effects of Intravenous Ketamine in Treatment-resistant Depression: a Randomized Controlled Trial (NCT03027362)

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.
  • Other: Cognitive behavioral therapy (CBT) and medication
    Sixteen sessions over 14 weeks.
    • Other: Psychoeducation and medication
      Ages eligible for Study
      18 Years to 65 Years
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      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).
      Status:
      not yet recruiting
      Type:
      Interventional
      Phase:
      -
      Start:
      31 December, 2016
      Updated:
      19 January, 2017
      Participants:
      28
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