Social Reward and Its Effect on Brain Functions in Psychotherapies for Mid- and Late-Life Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change in Resting State fMRI Connectivity of the Positive Valence System
研究概览
简要总结
Abnormalities in the Positive Valence System (PVS) are associated with depressive symptoms and reduced behavioral activation in mid- and late-life. This study will investigate the engagement of the PVS during exposure to social rewards, part of a novel streamlined psychotherapy for mid- and late-life depression. Use of computational modeling will enable identification of neuroimaging and behavioral profiles associated with greater treatment response, and may guide future personalization of psychotherapy.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages aged 50-85 [stratified so that 50% are older than 65]
- •Diagnosis of unipolar major depressive disorder without psychotic features, determined by the SCID
- •Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥
- •Mini Mental Status Exam (MMSE) ≤ 1 SD below the mean score for patient's age and education
- •Off antidepressants or on a stable dose of an antidepressant for 8 weeks and do not intend to change the dose in the next 10 weeks.
- •Capacity to provide written consent for research assessment and treatment.
排除标准
- •Intent or plan to attempt suicide in the near future.
- •History or presence of psychiatric diagnoses other than major depressive disorder without psychotic features, generalized anxiety disorder, or specific phobia.
- •Use of psychotropic drugs or cholinesterase inhibitors other than use of ≤ 0.5 mg of lorazepam daily up to seven times per week.
- •Neurological disorders (dementias, history of stroke, multiple sclerosis, Parkinson's disease, epilepsy, etc.); cardiac, renal, or respiratory failure; severe chronic obstructive pulmonary disease; metastatic cancer; or debilitated states or less common medical illnesses that may either influence brain systems of interest or ability to participate in the study. Dr. Alexopoulos or another research psychiatrist will review any medical illnesses that does not appear in the list above and determine whether it interferes with the study of positive valence system functions in depression.
- •Contraindications to MRI scanning including cardiac pacemaker, heart valve replacement, vascular stent, insulin pump, cochlear implant, any other metallic biomedical implant contraindicating to MRI, and claustrophobia.
结局指标
主要结局
Change in Resting State fMRI Connectivity of the Positive Valence System
时间窗: Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9)
Calculated from fMRI scan. Validation of target engagement (resting state functional connectivity (rsFC) within the right hemisphere orbital prefrontal cortex (OFC), specifically between the lateral and medial regions of the OFC).
次要结局
- Change in Montgomery Asberg Depression Rating Scale (MADRS)(Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9))
- Change in Behavioral Activation for Depression Scale (BADS)(Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9))