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Esketamine + Behavioural Activation Therapy for Depression

N/A
Recruiting
Led By Jeanne Talbot, MD PhD FRCP
Research Sponsored by The Royal's Institute of Mental Health Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 18-65
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
Must not have
The participant must not be receiving psychotherapy treatment outside the clinical trial for the duration of the study
Depression secondary to a stroke, cancer, or other severe medical illnesses
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to the end of the induction phase (week 4); additional efficacy assessment time points will include end of weeks 2, 8 and 12
Awards & highlights

Summary

This trial is testing if combining behavioural therapy with esketamine treatment can help people with severe depression feel better for a longer time.

Who is the study for?
This trial is for English-speaking adults aged 18-65 with major depressive disorder or bipolar disorder, who haven't improved after trying at least two different antidepressants. It's not for those with a history of brain hemorrhage, severe medical illnesses causing depression, active psychosis, recent substance abuse (except caffeine/nicotine), cognitive impairment, ketamine intolerance, or those in other psychotherapy.
What is being tested?
The study tests if combining Behavioural Activation Therapy—a psychological treatment encouraging new behaviors—with Esketamine can help people whose depression hasn't improved with standard treatments. Participants are randomly assigned to receive both treatments and monitored for recovery from depression.
What are the potential side effects?
Esketamine may cause dissociation (feeling disconnected from yourself), dizziness, nausea, sedation (feeling sleepy), increased blood pressure, anxiety and potential misuse. The side effects of Behavioural Activation Therapy are minimal but could include temporary increases in distress as new behaviors are practiced.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I haven't improved after two different antidepressants for my current severe depression.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not undergoing psychotherapy outside of this study.
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My depression is due to a stroke, cancer, or another severe illness.
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I have had a brain bleed or vascular disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to the end of the induction phase (week 4); additional efficacy assessment time points will include end of weeks 2, 8 and 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to the end of the induction phase (week 4); additional efficacy assessment time points will include end of weeks 2, 8 and 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in depressive symptoms
Secondary outcome measures
Change in participant perceived functioning
Speed of therapeutic effects

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Esketamine + Behavioural Activation TherapyExperimental Treatment2 Interventions
Participants randomized to this arm will be administered esketamine treatment as per standard clinical care in conjunction with behavioural activation (BA) therapy. Both treatments will be initiated in Week 1 of the induction phase (first 4 weeks of esketamine treatment).
Group II: Esketamine AloneActive Control1 Intervention
Participants randomized to this arm will be administered esketamine treatment as per standard clinical care and will be offered a course of BA therapy (12 one hour sessions) after their completion of the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Esketamine
2015
Completed Phase 3
~2520

Find a Location

Who is running the clinical trial?

The Royal's Institute of Mental Health ResearchLead Sponsor
5 Previous Clinical Trials
1,150 Total Patients Enrolled
Jeanne Talbot, MD PhD FRCPPrincipal InvestigatorThe Royal's Institute of Mental Health Research
~27 spots leftby Aug 2026
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