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NCT06431386Terminated

Behavioural Activation Therapy and Esketamine for Resistant Depression

Optimizing the Synergy Between Behavioural Activation Therapy and Esketamine for Resistant Depression

Source: ClinicalTrials.gov · Last updated 1 Oct 2025

Reason given: The study was terminated prematurely due to significant recruitment challenges.

Brief summary (registry, in English)

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.

Status (registry)
Terminated
Study type
Interventional
Enrollment
6 (actual)
First submitted
22 May 2024
Start date
11 Jun 2024
Primary completion date
17 Sept 2025
Lead sponsor
The Royal's Institute of Mental Health Research
NCT number
NCT06431386

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • The participant must not be receiving psychotherapy treatment outside the clinical trial for the duration of the study.

Other illness

  • Depression secondary to a stroke, cancer, or other severe medical illnesses.
  • A history of intracerebral hemorrhage, vascular disease.
  • A diagnosis of major neurocognitive disorder or a Montreal Cognitive Assessment (MOCA) score <24.
  • 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.

Other

  • Pregnant, lactating or of childbearing potential and unwilling to use an approved method of contraception during the study.
  • 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.
  • 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).

Who the study is looking for

  • 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.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
The Royal Ottawa Mental Health CentreOttawaCanadaUnknown status

Are you the coordinator? Confirm the details

This page is information, not medical advice. Discuss any trial with your doctor.