2025-522967-13-00招募中4 期
A multicenter randomized, controlled, single-blind, adaptive phase IV clinical trial to evaluate the efficiency and effectiveness of a pre-emptive pharmacogenetic strategy for antidepressant selection in patients with depressive disorder: The PREDICT adaptive clinical trial.
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz4 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2026年1月11日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- Symptom remission, based on changes in depression severity scores (PHQ-9 and MADRS), after initiation of a new antidepressant treatment following failure of the prior therapy at study entry.
研究概览
简要总结
Evaluate the effectiveness of a personalized medicine strategy that incorporates pre-emptive pharmacogenetic testing of biomarkers associated with antidepressant response, along with demographic, clinical, and concomitant medication data, compared to standard clinical practice in patients with depressive disorder who are initiating a new therapy following prior treatment failure.
研究设计
- 分配方式
- Randomized
- 主要目的
- A Multicenter Randomized, Controlled, Single-blind, Adaptive Phase Iv Clinical Trial To Evaluate Eff
- 盲法
- Single (Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Ability to understand the study's purpose and risks, provide informed consent, and authorize the use of confidential health information according to national and local privacy regulations.
- •Voluntary signing of the informed consent form (ICF).
- •Age += 18 years at the time of signing the ICF.
- •Ability and willingness to participate and follow the study for the majority of its duration.
- •Current first depressive episode, confirmed by a clinical diagnosis of depressive disorder according to standardized diagnostic criteria (e.g., ICD-11 or DSM-5), as documented in the medical record.
- •Currently receiving pharmacological treatment for depressive disorder at the time of study inclusion, with no more than one prior antidepressant treatment line, as determined by the treating physician.
- •Patient Health Questionnaire-9 (PHQ-9) Score: 10, and Montgomery-Asberg Depression Rating Scale (MADRS) Score: 18, both assessed within the two weeks preceding study inclusion.
- •No prior genotyping for CYP3A4, SLC6A4, HTR2A, CYP2D6, CYP2B6, or CYP2C19 genes.
- •Women of childbearing potential must agree to use highly effective contraception or practice sexual abstinence throughout the study and commit to avoiding pregnancy.
排除标准
- •Reports suicidal thoughts nearly every day, based on PHQ-9 item
- •Participants are unwilling or unable to comply with all scheduled visits, the treatment plan, laboratory tests, lifestyle considerations, or other study procedures.
- •Any condition or situation that precludes or interferes with compliance with the protocol.
- •The participant is currently enrolled in or has enrolled in a clinical trial within the three months preceding inclusion in the current study.
- •History of failure to respond or intolerance to more than one prior antidepressant treatment line for the current depressive episode.
- •History of manic, mixed, or hypomanic episodes, which are indicative of a bipolar disorder diagnosis and thus incompatible with inclusion in a depressive disorder trial.
- •A history of active psychotic episodes is indicative of a potential diagnosis of schizophrenia and is therefore considered incompatible with inclusion in a clinical trial for depressive disorders.
- •Depressive-like symptoms attributable to non-depressive conditions, such as Acute Stress Reaction, Uncomplicated Bereavement, or Premenstrual Dysphoric Disorder, which are excluded from the ICD-11 classification of depressive disorders.
- •Patients with a documented history of antidepressant treatment prescribed for Adjustment Disorder, Generalized Anxiety Disorder (GAD), or Post-Traumatic Stress Disorder (PTSD).
- •Currently hospitalized for psychiatric or medical reasons.
- •Have a known active drug substance abuse.
- •Pregnant or breastfeeding women, where pregnancy is defined as the state of a female after conception and until the termination of gestation.
结局指标
主要结局
Symptom remission, based on changes in depression severity scores (PHQ-9 and MADRS), after initiation of a new antidepressant treatment following failure of the prior therapy at study entry.
Symptom remission, based on changes in depression severity scores (PHQ-9 and MADRS), after initiation of a new antidepressant treatment following failure of the prior therapy at study entry.
次要结局
- Total number of therapeutic adjustments performed within 16 weeks after initiation of a new antidepressant treatment following failure of the prior therapy at study entry. “Therapeutic adjustment” includes: • Change of antidepressant (switch) • Dose increase or decrease (beyond standard titration)
- Total number and type of Psychotherapeutic appointments—such as cognitive behavioral therapy (CBT) and interpersonal therapy (IPT) per arm. • Total number of hospitalizations per arm. • Total number of clinical visits (scheduled and unscheduled). • Total number of non-scheduled psychiatric consultations in each arm.
- Incremental cost-effectiveness ratios (ICERs), comparing cost differences relative to differences in clinical efficacy between the two arms.
- Total number of adverse events (AEs) in each cohort.
- Total number of hospitalizations per arm.
- Total number of clinical visits (scheduled and unscheduled).
- Total number of non-scheduled psychiatric consultations in each arm.
- Total number of participants with symptom remission remains at the end of the 16-week follow-up period.
- Total costs in the intervention arm (including pharmacogenetic testing and clinical event costs) versus total costs related to clinical events in the control arm.
- Incremental cost of pharmacogenetic testing and associated implementation procedures.
- Total number of serious adverse events (SAEs) in each cohort.
- Total number of dropouts due to SAEs.
- Incidence of adverse events of special interest: Suicidal ideation, Suicide attempt, Serotonin syndrome, and Neuroleptic malignant syndrome.
研究者
Alberto Manuel Borobia Pérez
Scientific
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
研究点 (4)
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