Behavioural Activation Therapy and Ketamine for Treatment-Resistant Depression
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe Royal's Institute of Mental Health Research
About 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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
English speaking
Age 18-65 at Screening
Meeting criteria for major depressive disorder (MDD), in a major depressive episode without psychotic symptoms according to the Diagnostic and Statistical Manual for Mental Disorders (DSM-5)
Have not responded adequately to at least two separate courses of treatment with different antidepressants, each of adequate dose and duration, in the current depressive episode
Disqualifiers
Body mass index (BMI) ≥35
Depression secondary to a stroke, cancer, or other clinically significant medical illness, per study physician judgement
Not medically cleared to receive ketamine treatment due to presence of clinically relevant disease, per study physician judgement (e.g., uncontrolled hypertension, renal or hepatic impairment, significant coronary artery disease, vascular disease, diabetes mellitus, seizure disorder, intracerebral hemorrhage, history of cerebrovascular accident [CVA])
Pregnant, breastfeeding or of childbearing potential and unwilling to use an approved method of contraception during the study, as assessed during the Screening Visit medical clearance
Trial design
Design model
Parallel
Treatments tested in this trial
Ketamine (0.5 mg/kg)
DrugIV ketamine will be administered under medical supervision at a fixed dose of 0.5 mg/kg infused over 40 minutes. Treatments will be administered twice weekly for three weeks during the Induction Phase (6 treatments). Participants' response to ketamine will be assessed after the Induction Phase. Those who do not meet response criteria (\<50% reduction in MADRS score) will be deemed Nonresponders and will conclude receiving ketamine at that time. Those who meet the response criteria (≥50% reduction in MADRS score) will be deemed Responders and will proceed to the Maintenance Phase. During the Maintenance Phase, ketamine treatments will be administered once weekly for 8 weeks (8 treatments), followed by once biweekly for four weeks during the Discharge Preparation Phase (2 treatments). Responders will receive a total of 16 ketamine infusions over 15 weeks.
Behavioural Activation Therapy
BehavioralBA therapy is a structured, primarily talk therapy that focuses on helping people with depression increase engagement in positive, meaningful activities and reduce avoidance behaviors that reinforce low mood. The BA therapy protocol will be based on the approach described by Martell et al. (2022). Therapy sessions will be delivered virtually or in person according to participant preference. Participants in Arm 1 will receive a total of 16 BA sessions at a frequency of twice weekly for 3 weeks during the Induction Phase (6 sessions), once weekly for 8 weeks during the Maintenance Phase (8 sessions), and once biweekly for 4 weeks during the Discharge Preparation Phase (2 sessions). BA therapy sessions can occur on the same day as ketamine infusions, but not during or after the infusion.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Arm 1: Ketamine + Behavioural Activation TherapyExperimental treatment 2 interventions
Group B: Arm 2: Ketamine OnlyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in MADRS from Baseline
Estimated between-group difference in change in MADRS total score from baseline (Pre-Treatment/Week 0) to the end of the Induction Phase (Post-Induction/Week 3). Additional efficacy assessment time point will include end of study (Post-Treatment/Week 15).
Time frame
Week 0 to end of Week 3 and end of Week 15Secondary outcomes
1
Clinically Meaningful Antidepressant Outcomes
Estimated between-group differences in clinically meaningful antidepressant outcomes, including response rate (≥50% decrease in MADRS score) and remission rate (MADRS score ≤10), assessed from baseline (Pre-Treatment/Week 0) to end of Induction Phase (Post-Induction/Week 3), with additional assessment time point at the end of study (Post-Treatment/Week 15).
Time frame
Week 0 to end of Week 3 and end of Week 152
Change in Perceived Functioning from Baseline
Estimated between-group differences in changes in participant-reported functional outcomes, including self-reported depression, anxiety, quality of life, anhedonia, physical activity, and functional disability, assessed from baseline (Pre-Treatment/Week 0) to end of Induction Phase (Post-Induction/Week 3), with additional assessment time point at the end of study (Post-Treatment/Week 15).
Time frame
Week 0 to end of Week 3 and end of Week 15Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: