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TerminatedNot applicable

Behavioural Activation Therapy and Esketamine for Resistant Depression

NCT06431386 · The Royal's Institute of Mental Health Research

Closed to entry
Status
Not accepting participants
Not applicable
Phase
6
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

This is a randomized clinical trial to test the effectiveness of combining a proven psychological intervention called behavioural activation therapy alongside esketamine treatment for treatment resistant major depressive episodes in individuals with major depressive disorder or bipolar disorder. Encouraging participants to practice new behaviours while their mood is improved through esketamine treatment may lead to more lasting recovery from depression.

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

  • Change in depressive symptoms

    Measured over Baseline to the end of the induction phase (week 4); additional efficacy assessment time points will include end of weeks 2, 8 and 12

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: * English speaking * Ages 18-65 * Participants meeting criteria for major depressive disorder (MDD) or bipolar disorder, depressive episode without psychotic symptoms according to the Diagnostic and Statistical Manual for Mental Disorders (DSM-5). * Participants who have not responded adequately to at least two separate courses of treatment with different antidepressants, each of adequate dose and duration, in the current moderate to severe depressive episode. Exclusion Criteria: * Depression secondary to a stroke, cancer, or other severe medical illnesses. * Pregnant, lactating or of childbearing potential and unwilling to use an approved method of contraception during the study. * A history of intracerebral hemorrhage, vascular disease. * Active psychotic symptoms. * Current and/or recent history (\<12 months) of substance use/dependence (except for caffeine or nicotine) or problematic current alcohol use or dependence as defined by DSM-5 criteria. * A diagnosis of major neurocognitive disorder or a Montreal Cognitive Assessment (MOCA) score \<24. * Active suicidal intent with the absence of psychotic symptoms is not an exclusion criterion, as this is not atypical in individuals with treatment-resistant, and/or severe depression (safety monitoring will be carried out by research personnel/study psychiatrists). * Known history of intolerance or hypersensitivity to ketamine. * Any other condition that, in the opinion of the PI/study investigator(s), would adversely affect the participant's ability to complete the study or its measures. * The participant must not be receiving psychotherapy treatment outside the clinical trial for the duration of the study.

Where

1 study site

FacilityCityRegionCountry
The Royal Ottawa Mental Health CentreOttawaOntarioCanada

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.

NCT06431386 on ClinicalTrials.gov →

Last updated in the registry 2025-10-01. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits