Clinical trial NCT03027362: Cognitive Therapy to Sustain the Antidepressant Effects of Intravenous Ketamine in Treatment-resistant Depression
Official title: Cognitive Therapy to Sustain the Antidepressant Effects of Intravenous Ketamine in Treatment-resistant Depression: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Disorder, Major
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)
* 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).

Primary outcomes:
measure: Time to relapse of depression measured by the Montgomery-Asberg Depressive Rating Scale (MADRS) score.
timeFrame: Enrollment to 17 week follow-up
Secondary outcomes:
measure: Change in cognitive flexibility-working memory
timeFrame: Before the first ketamine treatment and 24 hours following the last ketamine treatment.
measure: Change in cognitive flexibility-executive function
timeFrame: Before the first ketamine treatment and 24 hours following the last ketamine treatment.
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Samuel Wilkinson, MD
role: PRINCIPAL_INVESTIGATOR
References: