Combining Behavioural Activation Therapy with Esketamine for Resistant Depression
Optimizing the Synergy Between Behavioural Activation Therapy and Esketamine for Resistant Depression
This study is testing if combining a therapy that encourages positive activities with esketamine can help people with hard-to-treat depression or bipolar disorder feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | The Royal's Institute of Mental Health Research Academic / other |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT06431386 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of combining behavioural activation therapy with esketamine treatment for individuals suffering from treatment-resistant major depressive disorder or bipolar disorder. The approach aims to enhance mood through esketamine while encouraging participants to engage in new behaviors that may lead to lasting recovery. The study targets individuals who have not responded adequately to traditional antidepressant medications, addressing a significant gap in current treatment options for severe depressive episodes.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults aged 18-65 with major depressive disorder or bipolar disorder who have not responded to at least two different antidepressant treatments.
Not a fit: Patients with depression secondary to severe medical illnesses, active psychotic symptoms, or a recent history of substance use may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective treatment option for patients with treatment-resistant depression, potentially leading to improved long-term outcomes.
How similar studies have performed: Other studies have shown promising results with ketamine and psychotherapy combinations, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ottawa, Ontario
- The Royal Ottawa Mental Health Centre — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Jeanne Talbot, MD PhD FRCP — The Royal's Institute of Mental Health Research
- Study coordinator: Research Coordinator
- Email: suzannah.wojcik@theroyal.ca
- Phone: 613-722-6521
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.