Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06431386
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-05-22
Brief Title:
Behavioural Activation Therapy and Esketamine for Resistant Depression
Sponsor:
The Royals Institute of Mental Health Research
Organization:
The Royals Institute of Mental Health Research
Study Overview
Official Title:
Optimizing the Synergy Between Behavioural Activation Therapy and Esketamine for Resistant Depression
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Depression is the leading cause of disability in the world and current treatments with medication are limited Over one-third of individuals with major depressive disorder MDD and one quarter of individuals with bipolar disorder BD do not benefit from traditional pharmacotherapies leading to treatment-resistant depressive episodes Individuals with treatment-resistant depressive episodes defined as a suboptimal response to two or more appropriate trials of antidepressant medication have a higher burden of illness higher healthcare utilization poorer quality of life worse occupational and social outcomes and are at greater risk of death Treatment-resistance may increase an individuals likelihood of engaging in suicidal behaviours and an estimated 30 percent of individuals with treatment-resistant depressive episodes will have a suicide attempt in their lifetime To address these gaps in treatment there has been growing interest in the use of intravenous IV ketamine as well as its newly marketed stereoisomer esketamine which is delivered intranasally
The discovery of the rapid antidepressant effects of low doses of ketamine has been hailed as a paradigm shift in psychiatry However a remaining challenge to address is the temporary nature of its effects Ketamine induces neuroplasticity-enhancing effects more than conventional medications for depression There may be the potential to harness this window of neuroplasticity to facilitate more lasting cognitive andor behavioural changes through psychotherapy To date there are no randomized clinical trials of combined treatment with esketamine and psychotherapy for treatment-resistant depressive episodes Studies to ensure that individuals can maximally benefit from this novel treatment are needed
The overall goal of this project is to maximize and sustain the beneficial effects of esketamine through combined treatment with behavioural activation BA therapy The central hypothesis is that combined esketamine and BA therapy will elicit larger and faster decrease in depressive symptoms and more improvement in functional recovery compared with esketamine treatment alone
The specific aims of this research study are as follows
Aim 1 To determine if there is a larger decrease in depressive symptoms in participants receiving BA concurrent with esketamine treatment compared to participants receiving esketamine alone
Aim 2 To compare the speed of antidepressant response in participants receiving BA concurrent with esketamine treatment compared to participants receiving esketamine alone
Aim 3 To assess if participants receiving BA concurrent with esketamine treatment perceive greater improvement in functioning self-reported depressive symptoms quality of life anhedonia hopelessness and work and social functioning compared to participants receiving esketamine alone
This study is a single-site parallel-arm randomized clinical trial investigating the effects of augmenting esketamine treatment with BA therapy an empirically supported treatment for depression
Participants will be randomized to one of two groups 1 concurrent esketamine and BA therapy started from treatment initiation or 2 esketamine treatment alone
Esketamine treatment will be offered as treatment as usual All study participants will be offered a 12 session course of BA therapy half will be randomized to receive BA concurrently with their esketamine treatment from initiation Participants randomized to the esketamine treatment alone arm will be offered a full course of BA sessions after week 12 during the maintenance phase of treatment or at the time esketamine treatment ceases whichever is earlier
BA therapy will be delivered virtually or in person according to participant preference mode of administration will be recorded and included in data analysis as appropriate The aim of BA therapy is to help individuals learn to observe the relationship between what they did felt and thought and what was happening around them and to identify conditions which maintained increased or weakened maladaptive behaviours Functional behaviour analysis will be used in problem and behaviour evaluation and in planning and reviewing changes introduced by participants between sessions Other techniques include self-observation and self-report elaboration of activity hierarchies behaviour programming rehearsal and behavioural modelling and contingency management Between-session homework will develop relevant and rewarding day-to-day routines liable to offer reinforcement in each participants environment An independent expert will assess the quality and adherence to BA for the trial
This will be the first clinical trial to test the concurrent use of esketamine and a behavioural intervention The efficacy data for esketamine largely comes from randomized controlled trials and thus may not always reflect the clinical reality for individuals who present for treatment in hospital settings Conducting research with esketamine in a naturalistic academic-hospital setting will inform clinical practice The goal is to offer esketamine to individuals as part of a comprehensive treatment plan to help them achieve longer-term recovery as opposed to short-lived decrease in clinical symptoms
The discovery of the rapid antidepressant effects of low doses of ketamine has been hailed as a paradigm shift in psychiatry However a remaining challenge to address is the temporary nature of its effects Ketamine induces neuroplasticity-enhancing effects more than conventional medications for depression There may be the potential to harness this window of neuroplasticity to facilitate more lasting cognitive andor behavioural changes through psychotherapy To date there are no randomized clinical trials of combined treatment with esketamine and psychotherapy for treatment-resistant depressive episodes Studies to ensure that individuals can maximally benefit from this novel treatment are needed
The overall goal of this project is to maximize and sustain the beneficial effects of esketamine through combined treatment with behavioural activation BA therapy The central hypothesis is that combined esketamine and BA therapy will elicit larger and faster decrease in depressive symptoms and more improvement in functional recovery compared with esketamine treatment alone
The specific aims of this research study are as follows
Aim 1 To determine if there is a larger decrease in depressive symptoms in participants receiving BA concurrent with esketamine treatment compared to participants receiving esketamine alone
Aim 2 To compare the speed of antidepressant response in participants receiving BA concurrent with esketamine treatment compared to participants receiving esketamine alone
Aim 3 To assess if participants receiving BA concurrent with esketamine treatment perceive greater improvement in functioning self-reported depressive symptoms quality of life anhedonia hopelessness and work and social functioning compared to participants receiving esketamine alone
This study is a single-site parallel-arm randomized clinical trial investigating the effects of augmenting esketamine treatment with BA therapy an empirically supported treatment for depression
Participants will be randomized to one of two groups 1 concurrent esketamine and BA therapy started from treatment initiation or 2 esketamine treatment alone
Esketamine treatment will be offered as treatment as usual All study participants will be offered a 12 session course of BA therapy half will be randomized to receive BA concurrently with their esketamine treatment from initiation Participants randomized to the esketamine treatment alone arm will be offered a full course of BA sessions after week 12 during the maintenance phase of treatment or at the time esketamine treatment ceases whichever is earlier
BA therapy will be delivered virtually or in person according to participant preference mode of administration will be recorded and included in data analysis as appropriate The aim of BA therapy is to help individuals learn to observe the relationship between what they did felt and thought and what was happening around them and to identify conditions which maintained increased or weakened maladaptive behaviours Functional behaviour analysis will be used in problem and behaviour evaluation and in planning and reviewing changes introduced by participants between sessions Other techniques include self-observation and self-report elaboration of activity hierarchies behaviour programming rehearsal and behavioural modelling and contingency management Between-session homework will develop relevant and rewarding day-to-day routines liable to offer reinforcement in each participants environment An independent expert will assess the quality and adherence to BA for the trial
This will be the first clinical trial to test the concurrent use of esketamine and a behavioural intervention The efficacy data for esketamine largely comes from randomized controlled trials and thus may not always reflect the clinical reality for individuals who present for treatment in hospital settings Conducting research with esketamine in a naturalistic academic-hospital setting will inform clinical practice The goal is to offer esketamine to individuals as part of a comprehensive treatment plan to help them achieve longer-term recovery as opposed to short-lived decrease in clinical symptoms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None