TerminatedN/Aketamine

Behavioural Activation Therapy and Esketamine for Resistant Depression

Sponsored by The Royal's Institute of Mental Health Research

NCT ID
NCT06431386
Target Enrollment
6 participants
Start Date
2024-06-11
Est. Completion
2025-09-17

About This Study

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.

Conditions Studied

Depressive Disorder, Treatment-ResistantDepressive Disorder, MajorBipolar Disorder

Interventions

  • Behavioural Activation (BA) Therapy
  • Esketamine

Eligibility

Age:18 Years - 65 Years
Healthy Volunteers:No
View full eligibility criteria
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.

Study Locations (1)

The Royal Ottawa Mental Health Centre
Ottawa, Ontario, Canada

This trial is not recruiting

This study is currently not accepting new participants.

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Data Source
ClinicalTrials.gov

Last updated from source