Promoting Enhanced Pharmacotherapy Choice Through Immunomarkers Evaluation in Depression
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Efficacy of CRP-consistent Antidepressant Selection Versus CRP-inconsistent Antidepressant Selection on Remission Rates in Patients With MDD.
研究概览
简要总结
PRECISE-D is a single site, randomized, open label 8-week clinical trial that will enroll 70 participants to evaluate if the level of inflammation in our body can predict how we will respond to antidepressants. C-reactive protein (CRP) is a substance in the body that is associated with inflammation. Previous research has suggested that people with high CRP (i.e., high inflammation levels) tend to have greater improvement of depressive symptoms with an antidepressant called bupropion, while individuals with low CRP (i.e., low inflammation levels) appear to have more benefit from selective serotonin reuptake inhibitors antidepressants (SSRI), such as escitalopram. However, it is not completely clear if CRP can predict your response to these two antidepressants.
Participants will undergo a screening visit that includes a physical exam, overall health evaluation, assessment of mental health history, and a toxicology and pregnancy test. Once screening is complete, participants will be randomized to one of two groups that will determine whether their CRP levels will be used to select which antidepressant they will receive. Participants will then complete 4 follow up visits at weeks 2, 4, 6, and 8. A follow-up phone call from the study team will occur at week 12.
详细描述
PRECISE-D is a single site, randomized, open label 8-week clinical trial that will enroll 70 participants. Participants will be asked to attend approximately 5 visits with the researchers or study staff.
The screening process will take approximately 2 hours, and will include a physical examination, toxicology and pregnancy test, as well as the completion of assessments. We will ask participants a series of questions regarding their general health, mental health history, and any medications they are currently taking. Additionally, some self-report questionnaires will be used as part of this process. The results of the screening exams, tests, and/or procedures will be reviewed to determine whether a participant will be allowed to continue in the study. In the event that there are questions about a participant's eligibility or screening procedures are remaining, the screening visit may be conducted over 2 visits.
Once eligibility is determined, the baseline visit (Week 0) will be completed. This visit will last approximately 1 hour and 15 minutes and will include the following:
- Bloodwork: We will obtain levels of CRP and other inflammatory substances. We will also examine electrolytes, kidney function, thyroid function, lipid panel, blood cell count, and other tests of general health.
- Self-Report Questionnaires: Participants will complete 8 questionnaires. These include questions about mental health and mood. The questionnaires range from 5 to 20+ items.
- Cognitive tests: We will examine the participant's attention, memory, and cognition using a series of computerized assessments.
Participants will be assigned to a study group based on their CRP level: CRP less than 1 (low CRP), or CRP greater than or equal to 1 (high CRP). Within this group assignment, participants will then be randomized, or assigned by chance (like flipping a coin), to one of 2 study groups:
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
盲法说明
Participant, care provider, investigator, and outcomes assessor will only be blinded to the participant's CRP levels and group assignment. However, the study is open label, meaning the participant, care provider, investigator, and outcomes assessor will know what medication the participant is taking.
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
- •Women and men ages 18-65
- •Current diagnosis of Major Depressive Disorder
- •Able to read, speak, and understand English
排除标准
- •Antidepressant use within the last 8 weeks
- •Active infection or uncontrolled autoimmune disease
- •Currently on oral corticosteroids or active immune suppressive therapy (methotrexate, cyclosporine, anti-cytokines medications, etc).
- •Current diagnosis of uncontrolled HIV, hepatitis C or significant immunodeficiency
- •Alcohol or substance use disorder
- •Positive urine drug test for illicit substances or substances used out of the context of prescription
- •Cognitively unable to give informed consent
- •Pregnant or breastfeeding women, women of childbearing potential who are not using an accepted means of birth control, or women with a positive urine pregnancy test
- •History of seizure disorder
- •Previous significant adverse reaction to escitalopram or bupropion
- •History of non-response to adequate doses of escitalopram or bupropion XL
- •Current use of concomitant psychotropic agents (anticonvulsants, benzodiazepines, hypnotics, opiates, triiodothyronine (T3), modafinil, psychostimulants, buspirone, melatonin, folate, l-methylfolate, s-adenosyl methionine, lithium) not on the same dose for at least four weeks prior to study entry or who do not agree to continue at the same dose during the acute phase of the study.
- •Lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder or other psychotic disorder
- •Current anorexia nervosa or bulimia nervosa
- •Suicidal ideation of the degree that, in the opinion of the evaluating clinician, participation in the study would place them at significantly increased risk of suicide
- •Unstable medical issues of such degree that, in the opinion of the evaluating clinician, participation in the study would place them at significant risk of a serious adverse event
研究组 & 干预措施
CRP<1, CRP consistent antidepressant selection
Participants with CRP<1 will be prescribed escitalopram
干预措施: Escitalopram (Drug)
CRP> or equal to 1, CRP consistent antidepressant selection
Participants with CRP> or equal to 1 will be prescribed bupropion XL
干预措施: Bupropion (Drug)
CRP<1, CRP inconsistent antidepressant selection
Participants with CRP< 1 will be prescribed bupropion XL
干预措施: Bupropion (Drug)
CRP> or equal to 1, CRP inconsistent antidepressant selection
Participants with CRP> or equal to 1 will be prescribed escitalopram
干预措施: Escitalopram (Drug)
结局指标
主要结局
Efficacy of CRP-consistent Antidepressant Selection Versus CRP-inconsistent Antidepressant Selection on Remission Rates in Patients With MDD.
时间窗: 1 year
The primary study endpoint will be remission rates based on the 16-items Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR), which will be extracted from the 30-item Inventory of Depressive Symptomatology (IDS-SR). The QIDS-SR score ranges from 0-27. A score of 5 or less represents remission.
Efficacy of CRP-consistent Antidepressant Selection Versus CRP-inconsistent Antidepressant Selection on Improving Social and Occupational Functioning.
时间窗: 12 weeks
Improvement in social and occupational functioning will be measured with the 5-item self-administered Work and Social Adjustment Scale (WSAS). The WSAS total score ranges from 0-40. Lower scores are better.
Adverse Antidepressant Treatment Effects on CRP-consistent Antidepressant Selection Versus CRP-inconsistent Antidepressant Selection
时间窗: 1 year
Side effects will be assessed using the 3-item self-administered Frequency, Intensity, and Burden of Side Effects (FIBSER). Each item is scored on a scale from 0-6. Items 1 and 2 (Frequency \& Intensity respectively) are to provide information to the clinician, but they are not used in the scoring.The score that is used comes only from Item 3 - Burden. Lower scores represents lower burden.
次要结局
- Optional Sub-study. Validity and Reliability of Capillary Blood CRP Measurement(Baseline)
研究者
Madhukar H. Trivedi, MD
Professor
University of Texas Southwestern Medical Center