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CompletedNot applicable

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

NCT03027362 · Yale University

Closed to entry
Status
Not accepting participants
Not applicable
Phase
28
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

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

    Measured over Enrollment to 17 week follow-up

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Not accepted
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).

Where

1 study site

FacilityCityRegionCountry
Yale UniversityNew HavenConnecticutUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT03027362 on ClinicalTrials.gov →

Last updated in the registry 2020-02-05. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits