Treatment Interrupts Depression Early
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Proportion of time spent depression free
研究概览
简要总结
The TIDE project aims to establish personal indicators for initial treatment choice for youth with first episode depression. Specifically, 100 adolescents and young adults (age 12 to 25) with untreated major depressive disorder of recent onset will be randomly allocated in 1:1 ratio to one of two evidence-based regimens for youth depression: (A) Individual cognitive-behavioural therapy; and (B) Optimized pharmacological treatment with an antidepressant. All participants will be offered active treatment for up to 1 year and follow-up for 2 years to establish short- and long-term outcomes, including change in depressive symptoms, maintenance of remission, core role functioning, achievement of educational, occupational and social milestones, and quality of life. Baseline characteristics including duration of untreated depression, pre-existing anxiety, attention-deficit/hyperactivity disorder, substance use, symptoms of reduced interest and activity, sleep, rhythm and melody of speech, brain function, history of childhood adversity, coping style, repetitive thinking, and family history of depression and bipolar disorder will be tested as potential moderators of outcome. Characteristics that differentially predict outcomes in those allocated to initial cognitive-behavioural therapy and those allocated to initial treatment with antidepressants will be combined into a personalized allocation algorithm.
详细描述
Design: TIDE is an open-label randomized trial with two parallel arms and long-term follow-up.
Participants: Youth and young adults with major depressive disorder will participate.
Recruitment: Young people aged 12 to 25 will be recruited through family physicians, child and adolescent mental health services (NSHA, IWK Central referral), student health, traditional advertisement (posters), and social media advertisement (Instagram, Facebook, Reddit, and Twitter).
Random allocation: Consenting eligible participants will be randomly allocated in 1:1 ratio to intervention A (cognitive-behavioral therapy) or intervention B (optimized antidepressant treatment), by an independent statistician using random blocks (block size 4 to 8), stratified by participant age (<18; ≥18). The allocation sequence will be held by a statistician at a separate location (the Research Methods Unit) and will remain concealed from the assessment and treatment team until the baseline assessment is completed.
Interventions: It is our aim to personalize the choice between established active treatments, not to test an active treatment against an inactive control. Therefore, the investigator will offer every participant entering the study an intervention that is established as safe and effective. Within the established interventions, the investigator chose two that have the largest amount of evidence for efficacy: cognitive-behavioural therapy and the antidepressant fluoxetine. These two interventions are at equipoise, meaning that the investigator has equally high expectation of treatment success from both approaches. Yet the two treatment strategies represent distinct choices, with intervention A relying on intensive psychological treatment and intervention B on optimized delivery of the best-established medication treatment for depression in youth.
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
- None
入排标准
- 年龄范围
- 12 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12-25 years
- •Diagnosis of major depressive disorder, onset of the major depressive disorder within the last 12 months. Depression considered the most significant problem in need of treatment.
- •An additional inclusion criterion for entering Stage 1 (active intervention) is a minimum moderate depression severity (CDRS-R≥40; MADRS≥20) that justifies the need for treatment. Individuals who fulfill general inclusion criteria but are below the depression severity threshold for active intervention will still be eligible to participate in follow-up assessments.
- •Verbal ability sufficient to participate in psychological treatment.
排除标准
- •Personal history of a manic or hypomanic episode, diagnosis of a psychotic disorder, pervasive developmental disorder or autism spectrum disorder, intellectual disability, mental disorders secondary to neurological or other medical condition, active substance use disorder.
- •Previous trial of any treatment for major depressive disorder lasting 4 weeks or longer, current use of antipsychotic, antidepressant or mood-stabilizer medication.
- •Recent (past 6 weeks) change in any psychotropic medication (including stimulants, hypnotics, anxiolytics) or receipt of 4 of more sessions of cognitive-behavioural therapy.
- •Pregnancy or breastfeeding. If participants become pregnant or learn of pregnancies during the study, we will consult with Dr. Tanya Tulipan and jointly make the best decision for the participant with the option to either continue or end study treatment.
- •No one will be excluded based on sex, gender, race, ethnicity, or living arrangements.
研究组 & 干预措施
Psychotherapy
Cognitive-behavioural therapy
干预措施: Cognitive-Behavioural Therapy (Behavioral)
Pharmacotherapy
Antidepressant medication
干预措施: Antidepressant medication (Drug)
结局指标
主要结局
Proportion of time spent depression free
时间窗: 16-104 weeks
At Stage 3 follow-up, the primary outcome will be the proportion of time spent depression free, defined as a score of 1 or 0 on Longitudinal Interval Follow-up Evaluation (LIFE).
Severity of depressive symptoms
时间窗: 16-32 weeks
The primary outcome measure at Stage 2 will be the severity of depressive symptoms, indexed with the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. The MADRS is scored on a scale from 0-60, the higher the score the higher the severity of symptoms.
次要结局
- Self-reported measure of quality of life.(1-104 weeks)
- Objective measures of educational progress.(1-104 weeks)
- Objective measure of physical activity.(1-104 weeks)
- Self-reported measure of depression.(1-104 weeks)
- Self-reported measure of generalized anxiety.(1-104 weeks)
- Objective measures of psychopathology.(1-104 weeks)
- Objective measures of sleep.(1-104 weeks)
- Self-reported measure of social anxiety.(1-104 weeks)
- Self-reported measures of general psychopathology.(1-104 weeks)