Behavioural Activation Therapy and Esketamine for Resistant Depression

This randomized clinical trial (n=40) aims to investigate the effectiveness of combining behavioural activation therapy (BA) with esketamine treatment for individuals with treatment-resistant major depressive (TRD) episodes due to major depressive disorder (MDD) or bipolar disorder (BD).

Depression presents a significant global burden, with many individuals not responding adequately to traditional pharmacotherapies. Esketamine, a derivative of ketamine, has shown rapid antidepressant effects, but its benefits are often short-lived. This trial seeks to explore whether combining esketamine with BA therapy can lead to more lasting recovery from depression.

Participants aged 18-65 with treatment-resistant depressive episodes will be enrolled. They will be randomly assigned to one of two groups: one receiving esketamine alongside BA therapy from the beginning of treatment, and the other receiving esketamine alone initially, with the option for BA therapy after week 12. BA therapy aims to help individuals identify and change maladaptive behaviours, with sessions conducted virtually or in person.

The study will assess the effectiveness of the combined treatment in reducing depressive symptoms, the speed of antidepressant response, and improvements in functioning. This is a single-site trial, conducted at The Royal Ottawa Mental Health Centre in Ontario, Canada. Dr. Jeanne Talbot leads the study, which is estimated to start in June 2024 and conclude in August 2026.

Topic Depression Treatment-Resistant Depression Bipolar Disorder
Compound Ketamine
Country Canada
Visit trial
Status Recruiting
Results Published No
Start date 01 June 2024
End date 31 August 2026
Phase Not Applicable
Design Open
Type Interventional
Generation First
Participants 40
Sex All
Age 18- 65
Therapy Yes

Trial Details

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.

Trial Number NCT06431386

Data attribution

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