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

Primary Purpose

Depressive Disorder, Major

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cognitive behavioral therapy (CBT) and medication

Psychoeducation and medication

About this trial

This is an interventional treatment trial for Depressive Disorder, Major

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Yale University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive behavioral therapy (CBT) and medication

Psychoeducation and medication

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in cognitive flexibility-working memory

Measured by n-back task

Change in cognitive flexibility-executive function

Measured by set shifting task (COGSTATE test)

Full Information

NCT ID

NCT03027362

First Posted

January 19, 2017

Last Updated

January 30, 2020

Sponsor

Yale University

1. Study Identification

Unique Protocol Identification Number

NCT03027362

Brief Title

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

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

January 2017 (Actual)

Primary Completion Date

September 30, 2019 (Actual)

Study Completion Date

January 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depressive Disorder, Major

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cognitive behavioral therapy (CBT) and medication

Arm Type

Experimental

Arm Description

Arm Title

Psychoeducation and medication

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Cognitive behavioral therapy (CBT) and medication

Intervention Description

Sixteen sessions over 14 weeks.

Intervention Type

Other

Intervention Name(s)

Psychoeducation and medication

Primary Outcome Measure Information:

Title

Time to relapse of depression measured by the Montgomery-Asberg Depressive Rating Scale (MADRS) score.

Description

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.

Time Frame

Enrollment to 17 week follow-up

Secondary Outcome Measure Information:

Title

Change in cognitive flexibility-working memory

Description

Measured by n-back task

Time Frame

Before the first ketamine treatment and 24 hours following the last ketamine treatment.

Title

Change in cognitive flexibility-executive function

Description

Measured by set shifting task (COGSTATE test)

Time Frame

Before the first ketamine treatment and 24 hours following the last ketamine treatment.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Samuel Wilkinson, MD

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale University

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06511

Country

United States

12. IPD Sharing Statement

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

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