Behavioral Activation + Ketamine for Depression
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to see if combining ketamine with behavioral activation (BA) therapy to treat moderate to severe treatment-resistant depression improves depressive symptoms and general functioning more than ketamine alone.
We aim to find out whether participants who receive both treatments:
1. Have greater reductions in depression symptoms than those who receive ketamine only
2. Have better response and remission rates than those who receive ketamine only
3. Experience better overall functioning, including mood, anxiety, quality of life, and physical activity than those who receive ketamine only
Participants will be randomized to one of two groups: Arm 1) concurrent ketamine and BA therapy started from treatment initiation, or Arm 2) ketamine treatment alone.
* All participants will undergo IV ketamine infusions administered twice weekly for three weeks.
* Half of the participants in will also undergo BA therapy sessions twice weekly for three weeks.
* Individuals with a sufficient treatment response after 3 weeks will proceed to undergo an additional 12 weeks of ketamine infusions (and those receiving BA therapy will continue to receive therapy for an additional 12 weeks).
Who Is on the Research Team?
Jeanne Talbot, MD, PhD
Principal Investigator
The University of Ottawa Institute of Mental Health Research (IMHR) at The Royal
Jennifer Phillips, PhD
Principal Investigator
The University of Ottawa Institute of Mental Health Research (IMHR) at The Royal
Are You a Good Fit for This Trial?
This trial is for adults with moderate to severe depression that hasn't improved after trying other treatments. Participants should be able to safely receive ketamine and take part in therapy sessions.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Behavioural Activation Therapy
- Ketamine
Trial Overview
The study compares two groups: one gets both IV ketamine infusions and behavioral activation (BA) therapy, while the other receives only ketamine. Treatments are given twice a week for three weeks, with possible extension if improvement is seen.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants receive IV ketamine infusions and concurrent BA therapy, both administered twice weekly for three weeks (Induction Phase). Responders to Induction Phase treatment will proceed to undergo an additional 12 weeks of ketamine infusions and BA therapy in the Maintenance and Discharge Preparation Phases (weekly for 8 weeks, then every other week for 4 weeks, respectively). Nonresponders to the Induction Phase will cease receiving ketamine infusions and will undergo an additional 12 weeks of BA therapy in the Maintenance and Discharge Preparation Phases (weekly for 8 weeks, then every other week for 4 weeks).
Participants will undergo IV ketamine infusions administered twice weekly for three weeks (Induction Phase). Responders to Induction Phase treatment will proceed to undergo an additional 12 weeks of ketamine infusions in the Maintenance and Discharge Preparation Phases (weekly for 8 weeks, then every other week for 4 weeks, respectively). Nonresponders to the Induction Phase will complete their study participation at this point.
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Royal's Institute of Mental Health Research
Lead Sponsor
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