Cognitive Therapy to Sustain the Antidepressant Effects of Intravenous Ketamine in Treatment-resistant Depression
| Status: | Recruiting |
|---|---|
| Conditions: | Depression, Depression, Major Depression Disorder (MDD) |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 6/16/2018 |
| Start Date: | January 2017 |
| End Date: | July 2019 |
| Contact: | Samuel Wilkinson, MD |
| Email: | Samuel.wilkinson@yale.edu |
| Phone: | : 203-764-9131 |
Cognitive Therapy to Sustain the Antidepressant Effects of Intravenous Ketamine in Treatment-resistant Depression: a Randomized Controlled Trial
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.
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.
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).
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