Optimizing the Synergy Between Behavioural Activation Therapy and Esketamine for Resistant Depression
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change in depressive symptoms
研究概览
简要总结
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.
详细描述
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 individual's 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 and/or 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Clinical outcome assessments will be performed by raters blind to treatment allocation and not the treating therapist or physician. Ratings will be acquired prior to treatment administration.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking
- •Ages 18-65
- •Participants meeting criteria for major depressive disorder (MDD) or bipolar disorder, depressive episode without psychotic symptoms according to the Diagnostic and Statistical Manual for Mental Disorders (DSM-5).
- •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.
排除标准
- •Depression secondary to a stroke, cancer, or other severe medical illnesses.
- •Pregnant, lactating or of childbearing potential and unwilling to use an approved method of contraception during the study.
- •A history of intracerebral hemorrhage, vascular disease.
- •Active psychotic symptoms.
- •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.
- •A diagnosis of major neurocognitive disorder or a Montreal Cognitive Assessment (MOCA) score <
- •Active suicidal intent with the absence of psychotic symptoms is not an exclusion criterion, as this is not atypical in individuals with treatment-resistant, and/or severe depression (safety monitoring will be carried out by research personnel/study psychiatrists).
- •Known history of intolerance or hypersensitivity to ketamine.
- •Any other condition that, in the opinion of the PI/study investigator(s), would adversely affect the participant's ability to complete the study or its measures.
- •The participant must not be receiving psychotherapy treatment outside the clinical trial for the duration of the study.
研究组 & 干预措施
Esketamine + Behavioural Activation Therapy
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).
干预措施: Behavioural Activation (BA) Therapy (Behavioral)
Esketamine + Behavioural Activation Therapy
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).
干预措施: Esketamine (Drug)
Esketamine Alone
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.
干预措施: Esketamine (Drug)
结局指标
主要结局
Change in depressive symptoms
时间窗: Baseline to the end of the induction phase (week 4); additional efficacy assessment time points will include end of weeks 2, 8 and 12
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score
次要结局
- Speed of therapeutic effects(Induction phase (weeks 1-4))
- Change in participant perceived functioning(Baseline to end of induction phase (week 4), and the end of weeks 8 and 12)
研究者
Dr. Jeanne Talbot
Physician Scientist
The Royal's Institute of Mental Health Research