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.
Cognitive Therapy to Sustain the Antidepressant Effects of Intravenous Ketamine in Treatment-resistant Depression
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.
Intervention / Treatment
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Cognitive behavioral therapy (CBT) and medication (OTHER)Sixteen sessions over 14 weeks.
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Psychoeducation and medication (OTHER)N/A
Condition or Disease
- Depressive Disorder, Major
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 18 Years to 65 Years |
| Enrollment: | 28 (ACTUAL) |
| Funded by: | Other |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
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Clinical Trial Dates
| Start date: | Jan 01, 2017 | ACTUAL |
|---|---|---|
| Primary Completion: | Sep 30, 2019 | ACTUAL |
| Completion Date: | Jan 15, 2020 | ACTUAL |
| Study First Posted: | Jan 23, 2017 | ESTIMATED |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Jan 30, 2020 |
Sponsors / Collaborators
Location
Participant Groups
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Following clinical ketamine treatment, the intervention includes sixteen CBT sessions over 14 weeks. In addition, standard of care medications for treatment of depression, will be prescribed by the principal investigator or by a psychiatrist unaffiliated with the trial. Participants will remain on the medication they were prescribed when they entered the study and will be expected not to adjust the medication unless clinically urgent.
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Following clinical ketamine treatment, the intervention includes psychoeducational sessions over 14 weeks.In addition, standard of care medications for treatment of depression, will be prescribed by the principal investigator or a by psychiatrist unaffiliated with the trial.
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Maximum Age: | 65 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
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).
* 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
Secondary Outcomes
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Measured by n-back task
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Measured by set shifting task (COGSTATE test)
More Details
| NCT Number: | NCT03027362 |
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| Other IDs: | 1609018450 |
| Study URL: | https://clinicaltrials.gov/study/NCT03027362 |
Last updated: Sep 29, 2023