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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
28
Sixteen sessions over 14 weeks.
Yale University
New Haven, Connecticut, United States
Time to relapse of depression measured by the Montgomery-Asberg Depressive Rating Scale (MADRS) score.
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.
Time frame: Enrollment to 17 week follow-up
Change in cognitive flexibility-working memory
Measured by n-back task
Time frame: Before the first ketamine treatment and 24 hours following the last ketamine treatment.
Change in cognitive flexibility-executive function
Measured by set shifting task (COGSTATE test)
Time frame: Before the first ketamine treatment and 24 hours following the last ketamine treatment.
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