Cognitive Therapy to Sustain the Antidepressant Effects of Intravenous Ketamine in Treatment-resistant Depression

Depressive Disorder, Major Clinical Trial

Official title:

Cognitive Therapy to Sustain the Antidepressant Effects of Intravenous Ketamine in Treatment-resistant Depression: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03027362
• Other study ID #: 1609018450
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: January 15, 2020

Study information

• Verified date: January 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 15, 2020
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Disorder, Treatment-Resistant

Intervention

Other:
• Cognitive behavioral therapy (CBT) and medication
Sixteen sessions over 14 weeks.
• Psychoeducation and medication

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Enrollment to 17 week follow-up
Secondary	Change in cognitive flexibility-working memory	Measured by n-back task	Before the first ketamine treatment and 24 hours following the last ketamine treatment.
Secondary	Change in cognitive flexibility-executive function	Measured by set shifting task (COGSTATE test)	Before the first ketamine treatment and 24 hours following the last ketamine treatment.