Stratified Pharmacological Approaches for Regulating Circuit-Level Effects Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- QIDS-SR: Quick Inventory of Depressive Symptomatology Self-Report
研究概览
简要总结
This research study aims to understand how people with depression respond to the medication pramipexole and to determine whether clinical response differs depending on the function of specific circuits in the brain. The investigators hope to learn which circuits are involved in depression and how these circuits interact with pramipexole to affect mood, behavior, and cognition.
Eligible participants will undergo an 8-week treatment course of pramipexole followed by a 2-week down taper and follow up. The ultimate goal is to offer people experiencing depression a medication that is alternative to ones that may not have worked in the past and to apply the knowledge the investigators gain from investigating the brain circuits involved in depression to help personalize treatment.
The investigators invite anyone who has recently experienced symptoms of depression to participate. A prior diagnosis of depression is not required.
详细描述
Participants will be asked to attend up to two in-person testing visits and commit to 10 weeks of treatment and remote participation.
The in-person testing visit at the beginning of the study lasts up to 4 hours. During this visit participants will undergo a non-invasive functional magnetic resonance imaging (fMRI) brain scan, complete game-like tasks in the scanner, and answer questions regarding emotional health.
Treatment involves an 8-week course of pramipexole and followed by a 2-week down taper and follow-up. During this 10-week period, participants will meet remotely with a study coordinator or study clinician each week to answer questions about medication side effects and emotional health and to complete online surveys to monitor mood.
Sign up online or contact the investigators to learn more about participating in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •18-65 years old (inclusive)
- •Fluent and literate in English, with non-impaired intellectual abilities to ensure adequate comprehension of the task instructions.
- •Willing to provide written, informed consent.
- •Functional magnetic resonance imaging (fMRI) scanning eligibility. All participants will need to successfully complete the screening forms at the Stanford Center for Cognitive and Neurobiological Imaging (CNI).
- •Patient Health Questionnaire-8 (PHQ-8) >/= 10
- •Meet the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnostic criteria for current or recurrent nonpsychotic Major Depressive Disorder (MDD) established by the Mini International Neuropsychiatric Interview (MINI)
排除标准
- •Suicidality with active plan or as determined clinician judgment
- •Current or lifetime history of medical illness or brain injury that may interfere with assessments as determined by clinician judgment
- •Severe impediment to vision, hearing, and/or hand movement likely to interfere with ability to complete the assessments, or is unable and/or unlikely to follow the study protocols as determined by clinician judgment
- •Pregnant, breastfeeding or unwilling or unable to use adequate birth control throughout the study
- •History of non-responsive depression to dopamine agonists
- •Any contraindication to being scanned in the 3.0T fMRI scanner, such as a cardiac pacemaker or implanted device that has not been cleared for scanning
- •Previous or current DSM-5 bipolar disorder (I, II, not otherwise specified), schizophrenia spectrum or other psychotic disorders, or psychosis or as determined by clinician judgment
- •Previous or current diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD)
- •Meeting DSM-5 criteria for current Obsessive-Compulsive Disorder (OCD) or eating disorder
- •Meeting DSM-5 criteria for alcohol use disorder or substance use disorder within the last 12 months
- •Clinically significant presence/history of impulsive-compulsive behaviors or control disorder including but not limited to gambling disorder within the last 12 months.
- •Current use or use of psychotropic medication within the past month. (If the participant's usual treating clinician agrees with discontinuing the medication, participants may enroll after tapering off the medication under the supervision of either their usual clinician or the study clinician. A washout period of 5 half-lives-or a different duration as determined by the study clinician-must be completed before the first scan.)
- •Concurrent participation in other intervention or treatment studies
研究组 & 干预措施
Pramipexole Treatment Arm
The investigators will ask eligible participants to attend up to 2 in-person testing visits and commit to 10 weeks of treatment and remote participation.
The in-person testing visit at the beginning of the study lasts up to 4 hours. During this visit participants will undergo a non-invasive functional magnetic resonance imaging (fMRI) brain scan, complete game-like tasks in the scanner, and answer questions regarding emotional health.
Treatment involves an 8-week course of pramipexole and followed by a 2-week down titration and follow up. During this 10-week period, participants will meet remotely with a study coordinator or study clinician each week to answer questions about medication side effects and emotional health and to complete online surveys to monitor mood.
干预措施: Pramipexole Immediate Release (Drug)
结局指标
主要结局
QIDS-SR: Quick Inventory of Depressive Symptomatology Self-Report
时间窗: 8 weeks
The QIDS-SR (Quick Inventory of Depressive Symptomatology - Self-Report) is a self-report questionnaire designed to assess the severity of depressive symptoms over the past seven days. It includes 16 items that evaluate 9 symptom domains corresponding to the Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria for major depressive disorder: sad mood, concentration difficulties, self-criticism or guilt, suicidal ideation, loss of interest, low energy or fatigue, sleep disturbances, changes in appetite or weight, and psychomotor agitation or retardation. Each domain is rated on a scale from 0 to 3, with total scores ranging from 0 to 27. Scores are interpreted as follows: 0-5 indicates no depression, 6-10 mild, 11-15 moderate, 16-20 severe, and 21-27 very severe depression. It is brief, taking approximately 5 to 10 minutes to complete.
MASQ-30: Mood Anxiety Symptom Questionnaire
时间窗: 8 weeks
The MASQ-30 (Mood and Anxiety Symptom Questionnaire - 30-item version) is a self-report questionnaire designed to measure symptoms of depression and anxiety. It separate symptoms that are shared between depression and anxiety from those that are more specific to each condition. The MASQ-30 includes 30 questions, divided into three main areas: Anhedonic Depression, which looks at symptoms like loss of interest or pleasure; Anxious Arousal, which focuses on physical signs of anxiety such as restlessness or a racing heart; and General Distress, which captures overall emotional discomfort common to both depression and anxiety. Each question asks how much the person has experienced a particular symptom in the past week, using a scale from 1 ("not at all") to 5 ("extremely").
Brain imaging
时间窗: 8 weeks
Non-invasive brain circuit quantification as assessed by functional magnetic resonance imaging metrics of activation and connectivity.
Cognitive-Emotional Behavioral Assessment
时间窗: 8 weeks
WebNeuro is a computerized cognitive-emotional behavioral assessment designed to objectively measure cognitive and emotional function.
次要结局
- DARS: Dimensional Anhedonia Rating Scale(8 weeks)
- PHQ-9: Patient Health Questionnaire-9(8 weeks)
- HAM-D-17: Hamilton Depression Rating Scale(8 weeks)
- SWLS: Satisfaction With Life Scale(8 weeks)
- WHOQoL-BREF: The World Health Organization Quality of Life - BREF(8 weeks)
研究者
Leanne Williams
Professor of Psychiatry and Behavioral Sciences
Stanford University