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

NCT03027362 | Completed

• 1 other identifier: 1609018450
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in cognitive flexibility-working memory

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

• Change in cognitive flexibility-executive function

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

Study Arms (2)

Cognitive behavioral therapy (CBT) and medication

EXPERIMENTAL

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.

Other: Cognitive behavioral therapy (CBT) and medication

Psychoeducation and medication

ACTIVE COMPARATOR

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.

Other: Psychoeducation and medication

Interventions

Cognitive behavioral therapy (CBT) and medication OTHER

Sixteen sessions over 14 weeks.

Cognitive behavioral therapy (CBT) and medication

Psychoeducation and medication OTHER

Psychoeducation and medication

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Cognitive Behavioral Therapy; Dosage Forms

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Samuel Wilkinson, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: January 23, 2017
• Study Start: January 1, 2017
• Primary Completion: September 30, 2019
• Study Completion: January 15, 2020
• Last Updated: February 5, 2020

Record last verified: 2020-01

Locations

US (1)