Esketamine + Behavioural Activation Therapy for Depression
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: The Royal's Institute of Mental Health Research
Must be taking: Antidepressants
Disqualifiers: Stroke, Cancer, Substance use, others
No Placebo Group
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?This is a randomized clinical trial to test the effectiveness of combining a proven psychological intervention called behavioural activation therapy alongside esketamine treatment for treatment resistant major depressive episodes in individuals with major depressive disorder or bipolar disorder. Encouraging participants to practice new behaviours while their mood is improved through esketamine treatment may lead to more lasting recovery from depression.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, it does mention that participants must not be receiving psychotherapy treatment outside the clinical trial.
What data supports the effectiveness of the drug esketamine for depression?
Research shows that esketamine, when used with standard antidepressants, can help people with major depressive disorder who have not responded to other treatments. It has been found to work quickly and effectively in reducing symptoms, especially in those with severe depression and suicidal thoughts.
12345Is the combination of Esketamine and Behavioral Activation Therapy safe for humans?
Esketamine, used for treatment-resistant depression, has shown safety in humans, but there are concerns about its potential for addiction. Safety monitoring is important, and while it is generally safe, it should be used under medical supervision.
46789How is Behavioural Activation Therapy combined with esketamine unique for treating depression?
Behavioural Activation Therapy (BAT) combined with esketamine is unique because it pairs a psychological approach that encourages engagement in positive activities with a fast-acting medication that targets NMDA receptors, offering a novel option for those who haven't responded to traditional antidepressants.
1391011Eligibility Criteria
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.Inclusion Criteria
English speaking
I am between 18 and 65 years old.
I have been diagnosed with major depression or bipolar depression without psychosis.
+1 more
Exclusion Criteria
Active psychotic symptoms
I am not undergoing psychotherapy outside of this study.
Current and/or recent history (<12 months) of substance use/dependence (except for caffeine or nicotine) or problematic current alcohol use or dependence as defined by DSM-5 criteria
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Induction
Participants receive esketamine treatment with or without concurrent behavioural activation therapy
4 weeks
Weekly visits (in-person or virtual)
Maintenance
Participants continue esketamine treatment; those in the esketamine alone group may start BA therapy
8 weeks
Bi-weekly visits (in-person or virtual)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Royal Ottawa Mental Health CentreOttawa, Canada
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Who Is Running the Clinical Trial?
The Royal's Institute of Mental Health ResearchLead Sponsor
References
Establishing an esketamine clinic in Australia: Practical recommendations and clinical guidance from an expert panel. [2023]Major depressive disorder (MDD) can have severe impacts on function and quality of life. Up to one third of patients will have an inadequate response to their first line of treatment, with subsequent lines of therapy associated with lower remission rates and higher relapse rates. Recently esketamine has become available for Australian patients, and this agent provides an additional treatment option for those with MDD who have had an inadequate response to two or more antidepressant therapies during the current moderate to severe depressive episode. This paper provides an expert panel's practical recommendations and clinical guidance for establishing esketamine clinics in Australia.
Esketamine versus placebo on time to remission in major depressive disorder with acute suicidality. [2023]Esketamine (ESK) nasal spray, taken with oral antidepressant therapy, is approved for the treatment of depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior. In pooled analyses of two pivotal phase 3 studies, ASPIRE I and II, remission rates were consistently higher among patients with MDD with active suicidality who were treated with ESK + standard of care (SOC) versus placebo (PBO) + SOC at all time points in the double-blind and most time points in the follow-up phases. The current analysis of the ASPIRE data sets assessed the effect of ESK + SOC versus PBO + SOC on additional remission-related endpoints: time to achieving remission and consistent remission, proportion of patients in remission and consistent remission, and days in remission.
[Research progress of depression and the application of esketamine]. [2020]The pathogenesis and etiology of still remain unknown. Current evidence suggests that the occurrence of depression may be related to a reduced secretion of neurotransmitters, neuronal apoptosis, inflammation, intestinal flora and other factors. Although the commonly used antidepressants such as SSRIs, SNRIs, NaSSA, and SARIs produce some therapeutic effects, they fail to relieve the full spectrum of the symptoms of depression. In recent years, esketamine was found to produce a potent and a long-lasting antidepressant effect by acting on the NMDA receptors. Herein the authors review the progress in the study of the pathogenesis and drug therapies of depression, the efficacy of esketamine treatment and the underlying mechanism, and the prospect of esketamine treatment. Currently the mechanism of the antidepressant effect of esketamine remains indeterminate and its clinical application is limited, but its effect in rapidly alleviating the symptoms of depression suggests its bright prospect for clinical applications.
Synthesizing the Evidence for Ketamine and Esketamine in Treatment-Resistant Depression: An International Expert Opinion on the Available Evidence and Implementation. [2022]Replicated international studies have underscored the human and societal costs associated with major depressive disorder. Despite the proven efficacy of monoamine-based antidepressants in major depression, the majority of treated individuals fail to achieve full syndromal and functional recovery with the index and subsequent pharmacological treatments. Ketamine and esketamine represent pharmacologically novel treatment avenues for adults with treatment-resistant depression. In addition to providing hope to affected persons, these agents represent the first non-monoaminergic agents with proven rapid-onset efficacy in major depressive disorder. Nevertheless, concerns remain about the safety and tolerability of ketamine and esketamine in mood disorders. Moreover, there is uncertainty about the appropriate position of these agents in treatment algorithms, their comparative effectiveness, and the appropriate setting, infrastructure, and personnel required for their competent and safe implementation. In this article, an international group of mood disorder experts provides a synthesis of the literature with respect to the efficacy, safety, and tolerability of ketamine and esketamine in adults with treatment-resistant depression. The authors also provide guidance for the implementation of these agents in clinical practice, with particular attention to practice parameters at point of care. Areas of consensus and future research vistas are discussed.
Efficacy of Esketamine Nasal Spray Plus Oral Antidepressant Treatment for Relapse Prevention in Patients With Treatment-Resistant Depression: A Randomized Clinical Trial. [2021]Controlled studies have shown short-term efficacy of esketamine for treatment-resistant depression (TRD), but long-term effects remain to be established.
Use of ketamine and esketamine for depression: an overview of systematic reviews with meta-analyses. [2022]To summarize the evidence of efficacy and safety of the use of ketamine and esketamine for depression.
The Ketamine Side Effect Tool (KSET): A comprehensive measurement-based safety tool for ketamine treatment in psychiatry. [2023]On a background of the rapidly expanding clinical use of ketamine and esketamine for treatment of depression and other conditions, we examined safety monitoring, seeking to identify knowledge gaps relevant to clinical practice.
Craving and addictive potential of esketamine as side effects? [2022]Esketamine was approved for adults with treatment-resistant depression (TRD) in conjunction with an oral antidepressant, and for treating depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior. However, evidence of great efficacy and safety of esketamine is accompanied by a widespread concern regarding its addictive potential.
Intranasal esketamine: A novel drug for treatment-resistant depression. [2021]To review the efficacy, safety, and place in therapy of intranasal esketamine, a treatment modality for treatment-resistant depression.
Treatment Response With Esketamine Nasal Spray Plus an Oral Antidepressant in Patients With Treatment-Resistant Depression Without Evidence of Early Response: A Pooled Post Hoc Analysis of the TRANSFORM Studies. [2021]Objective: To evaluate response to esketamine nasal spray plus an oral antidepressant (ESK + AD) at day 28 in patients with major depressive disorder (DSM-5) and treatment-resistant depression (TRD) who did not meet response criteria within the first week of treatment.
Characteristics of Real-world Commercially Insured Patients With Treatment-resistant Depression Initiated on Esketamine Nasal Spray or Conventional Therapies in the United States. [2022]This study aimed to characterize patients with treatment-resistant depression (TRD) initiating esketamine or conventional therapies.