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

NCT ID: NCT03027362

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2020-01-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cognitive behavioral therapy (CBT) and medication

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.

Group Type: EXPERIMENTAL

Cognitive behavioral therapy (CBT) and medication

Intervention Type: OTHER

Sixteen sessions over 14 weeks.

Psychoeducation and medication

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.

Group Type: ACTIVE_COMPARATOR

Psychoeducation and medication

Intervention Type: OTHER

Interventions

Cognitive behavioral therapy (CBT) and medication

Sixteen sessions over 14 weeks.

Intervention Type: OTHER

Psychoeducation and medication

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samuel Wilkinson, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

1609018450

Identifier Type: -

Identifier Source: org_study_id