Clinical TrialMajor Depressive Disorder (MDD)Completed

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.

Target Enrollment
28 participants
Study Type
Phase NA interventional
Design
Randomized, single Blind

Detailed Description

Randomised, single-blind (outcomes assessor) parallel-group trial of CBT versus psychoeducation following clinical ketamine in treatment-resistant major depressive disorder. Participants who responded to clinical ketamine (≥50% reduction on MADRS) were randomised to receive either 16 CBT sessions over 14 weeks or psychoeducation, while remaining on standard medications.

Primary aims were to assess whether intensive CBT sustains ketamine's antidepressant effects and to evaluate ketamine's delayed effects on learning and memory and their relation to treatment durability.

Study Protocol

Preparation

sessions

Dosing

sessions

Integration

sessions

Therapeutic Protocol

cbt

Study Arms & Interventions

CBT + medication

experimental

Sixteen CBT sessions over 14 weeks delivered after clinical ketamine; participants remain on standard antidepressant medication.

Interventions

  • Compound
    via Other• 16 sessions over 14 weeks

    CBT plus standard antidepressant medication following clinical ketamine treatment

Psychoeducation + medication

active comparator

Psychoeducational sessions over 14 weeks plus standard antidepressant medication delivered after clinical ketamine.

Interventions

  • Compound
    via Other• sessions over 14 weeks

    Psychoeducation plus standard antidepressant medication following clinical ketamine treatment

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion 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)
  • 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

  • Exclusion Criteria:
  • Any Axis I or Axis II disorder clinically predominant to their depressive episode or predominant 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)

Study Details

  • Status
    Completed
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizedsingle Blind
  • Target Enrollment28 participants
  • Timeline
    Start: 2017-01-01
    End: 2020-01-15
  • Topic
    Major Depressive Disorder (MDD)

Locations

Yale University — New Haven, Connecticut, United States

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