Depressive Disorder, Major
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 medicationSixteen 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|
- 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.
- 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).
not yet recruiting
31 December, 2016
19 January, 2017