Precision Care for Major Depressive Disorder
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Quick Inventory of Depressive Symptoms - Self-Report 16-Item (QIDS-SR-16) score
研究概览
简要总结
This study aims to assess whether phenotyping-guided intervention selection is superior to intervention selection without phenotyping guidance (i.e., routine clinician and patient judgment regarding treatment selection) for depression.
详细描述
This study will classify patients seen in the Depression Clinic of the UCSF Department of Psychiatry and Behavioral Sciences into one of five phenotypes (subtypes), including: 1) Anhedonia, 2) Cognitive deficits, 3) Stress sensitivity, 4) Anxious distress, and 5) Grief.
After phenotyping, participants will be randomized to receive phenotype-specific intervention (PSI) or care as usual (CAU).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is able to provide informed consent
- •English speaker
- •18 years of age or older at time of consent
- •Meets DSM-5 criteria for Major Depressive Disorder
- •The subject meets eligibility criteria for at least one study phenotype as determined by assessments, imaging and/or clinical judgment.
- •PHQ-8 score at baseline of >= 10
- •Scheduled for or completed intake in UCSF outpatient psychiatry
排除标准
- •Unstable or untreated medical or psychiatric condition based on clinical assessment by investigator(s)
- •Significant risk of suicidal or violent behavior as determined by clinical judgement
- •In the Investigators' opinion, the subject is not capable of adhering to the protocol requirements, or the subject has a history of poor or suspected poor compliance in clinical research studies, or the subject has a history of poor or suspected poor compliance to antidepressant medication or that study participation is not in their best interest (e.g., different treatment is indicated given their clinical presentation)
- •Pregnant or breastfeeding or planning to become pregnant during the study
研究组 & 干预措施
Anxious distress: PSI
干预措施: Phenelzine (Drug)
Anxious distress: CAU
干预措施: Care as usual (CAU) plan (Other)
Grief: PSI
干预措施: Complicated Grief Treatment (CGT) (Behavioral)
Grief: CAU
干预措施: Care as usual (CAU) plan (Other)
Anhedonia phenotype: PSI
干预措施: Pramipexole (Drug)
Anhedonia phenotype: CAU
干预措施: Care as usual (CAU) plan (Other)
Cognitive deficits: PSI
干预措施: Methylphenidate (Drug)
Cognitive deficits: CAU
干预措施: Care as usual (CAU) plan (Other)
Stress sensitivity: PSI
干预措施: Mindfulness-based Stress Sensitivity Therapy (MBSST) (Behavioral)
Stress sensitivity: CAU
干预措施: Care as usual (CAU) plan (Other)
结局指标
主要结局
Quick Inventory of Depressive Symptoms - Self-Report 16-Item (QIDS-SR-16) score
时间窗: Up to 24 weeks after randomization.
Within-phenotype and across-phenotype contrasts.
次要结局
- Snaith-Hamilton Pleasure Scale (SHAPS) score(Up to 24 weeks after randomization.)
- Clinically Useful Depression Outcome Scale Anxious Distress Specifier Subscale (CUDOS-A) score(Up to 24 weeks after randomization.)
- Generalized Anxiety Disorder 7-item (GAD-7) score(Up to 24 weeks after randomization.)
- Inventory of Complicated Grief (ICG) score(Up to 24 weeks after randomization.)
- Perceived Deficits Questionnaire - Depression (PDQ-D) score(Up to 24 weeks after randomization.)
- Patient Health Questionnaire - 8 (PHQ-8) score(Up to 24 weeks after randomization.)
- WHO Disability Assessment Schedule (WHODAS 2.0)(Up to 24 weeks after randomization.)
- Quick Inventory of Depressive Symptoms - Self-Report 16-Item (QIDS-SR-16) response(Up to 24 weeks after randomization.)
- Quick Inventory of Depressive Symptoms - Self-Report 16-Item (QIDS-SR-16) remission(Up to 24 weeks after randomization.)