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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

No Placebo-Only Group

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 weeks3 visits

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in depressive symptoms

Secondary study objectives

Change in participant perceived functioning

Speed of therapeutic effects

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 5Eligibility criteria met