Behavioural Activation Therapy and Esketamine for Resistant Depression

Launched by THE ROYAL'S INSTITUTE OF MENTAL HEALTH RESEARCH · May 22, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help people who are struggling with severe depression that hasn't improved with standard treatments. The study combines two approaches: a type of therapy called behavioral activation therapy, which encourages people to engage in positive activities, along with a medication called esketamine. The goal is to see if this combination can help improve mood and lead to longer-lasting recovery from depression for individuals with major depressive disorder or bipolar disorder.

To participate, individuals must be between 18 and 65 years old, speak English, and have been diagnosed with major depressive disorder or a depressive episode related to bipolar disorder. Importantly, they should have tried at least two different antidepressants without getting better. Participants can expect to receive both the therapy and the medication during the study, with careful monitoring by the research team to ensure their safety. If someone is feeling suicidal but does not have other severe symptoms, they can still join the study, as the team will provide additional support. It’s important to note that participants cannot be receiving any other therapy while in this trial.

Gender

ALL

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.