Treatment Resistant Depression / Behavioural Activation Therapy / Ketamine (0.5 mg/kg) · Phase 2/3 Trial

Behavioural Activation Therapy and Ketamine for Treatment-Resistant Depression

ClinicalTrials.gov · September 3, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned randomized controlled trial of ketamine combined with behavioral activation therapy versus ketamine alone in treatment-resistant depression. No results are yet available in this registry record. The study aims to assess whether the combination yields greater symptom reduction, response and remission rates, and functional improvement over 15 weeks.

What was studied

Phase 2/3, Interventional, Randomized, Parallel, Single masking, Treatment purpose. Treatment Resistant Depression, Major Depressive Disorder (MDD); age from 18 Years; to 65 Years. Intervention: Arm 1: Ketamine + Behavioural Activation Therapy. Compared with: Arm 2: Ketamine Only — Active Comparator. n = 60. 1 site: Canada.

Key findings

Safety

This is a trial registration only; no efficacy, safety, or outcome data are reported.

Who this may help

This trial is not yet recruiting and has posted no results. Clinicians should monitor for published outcomes before any clinical decision-making; the combination strategy is investigational.

Plain-language summary

This is a Phase 2/3 trial registration with no posted results; it describes a planned intervention combining ketamine and behavioral activation for treatment-resistant depression but carries no efficacy or safety data.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Change in MADRS from Baseline (assessed at Week 0 to end of Week 3 and end of Week 15)

DesignPhase 2/3, Interventional, Randomized, Parallel, Single masking, Treatment purpose

PopulationTreatment Resistant Depression, Major Depressive Disorder (MDD); age from 18 Years; to 65 Years

Sample size60

InterventionArm 1: Ketamine + Behavioural Activation Therapy

ComparatorArm 2: Ketamine Only — Active Comparator

Setting1 site: Canada

Reported figures

Quoted from the source exactly as published.

Planned enrollment60

Primary outcome measureChange in MADRS from Baseline (Week 0) to end of Week 3 and end of Week 15

Ketamine dose0.5 mg/kg

Ketamine infusion frequencyTwice weekly for 3 weeks; responders proceed to additional 12 weeks

Behavioral Activation Therapy frequencyTwice weekly for 3 weeks; continues for additional 12 weeks in responders

Clinical bottom line

This trial is not yet recruiting and has posted no results. Clinicians should monitor for published outcomes before any clinical decision-making; the combination strategy is investigational.

Caveats

This is a trial registration only; no efficacy, safety, or outcome data are reported.
Blinding status, allocation concealment method, and specific eligibility criteria are not detailed in this registry record.
Study has not yet begun recruitment (NOT_YET_RECRUITING status).
Phase designation (2/3 combined) and modest sample size limit current inference about statistical power.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Randomized controlled trial with two arms and defined allocation.

Directness

strong

Direct comparison of combined intervention versus ketamine monotherapy in treatment-resistant depression.

Consistency

insufficient

No results yet posted; consistency cannot be assessed.

Risk of bias

insufficient

Blinding, allocation concealment, and conduct details not described in registry record.

Sample adequacy

limited

Estimated 60 participants total across two arms; modest for Phase 2/3.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07801703). This is a study registration, not published results. Lead sponsor: The Royal's Institute of Mental Health Research. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE2, PHASE3. Study type: INTERVENTIONAL. Enrollment: 60 participants (ESTIMATED). Conditions: Treatment Resistant Depression, Major Depressive Disorder (MDD). Interventions: DRUG: Ketamine (0.5 mg/kg); BEHAVIORAL: Behavioural Activation Therapy. Primary outcome measures: Change in MADRS from Baseline , Week 0 to end of Week 3 and end of Week 15. Brief summary: 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).

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

The Royal's Institute of Mental Health ResearchTreatment Resistant DepressionBehavioural Activation TherapyNCT07801703Ketamine (0.5 mg/kg)Major Depressive Disorder (MDD)