Depressive Disorder, Major
Conditions
Brief summary
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.
Interventions
OTHERCognitive behavioral therapy (CBT) and medication
Sixteen sessions over 14 weeks.
OTHERPsychoeducation and medication
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to relapse of depression measured by the Montgomery-Asberg Depressive Rating Scale (MADRS) score. | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in cognitive flexibility-working memory | Before the first ketamine treatment and 24 hours following the last ketamine treatment. | Measured by n-back task |
| Change in cognitive flexibility-executive function | Before the first ketamine treatment and 24 hours following the last ketamine treatment. | Measured by set shifting task (COGSTATE test) |
Countries
United States
Outcome results
None listed