An Precision Immunopsychiatric Pharmacological Probe of Adalimumab as an Anti-depressant
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline in individual somatic, affective, and motivational depressive symptoms, as measured by the Quick Inventory of Depressive Symptomatology (QIDS)
研究概览
简要总结
The goal of this clinical trial is to learn if the anti-inflammatory medication adalimumab improves depressive symptoms in adults with Major Depressive Disorder (MDD) who are already taking the anti-depressant medication Lexapro (escitalopram).
The main questions it aims to answer are:
- Does adalimumab improve the symptoms of some patients with MDD who are already taking an anti-depressant?
- What characteristics predict for whom adalimumab has anti-depressant properties.
Researchers will compare adalimumab to a placebo (a look-alike substance that contains no drug) to see if adalimumab works to improve depressive symptoms as an add-on drug to the anti-depressant Lexapro (escitalopram).
For these primary aims the participants will:
- Visit the clinic once every 2 weeks for a checkups and injection of adalimumab or placebo from the study psychiatrist (Day 1, 15, 29, and 43 for injections)
- Complete short (<5 min) daily surveys for the 57 day duration of the study.
详细描述
This is a 57-day intensive longitudinal study of 60 adult subjects with Major Depressive Disorder and elevated baseline tumor necrosis factor (TNF) levels. A triple-blind, placebo-controlled pharmacological investigation of adalimumab as an adjunctive medication to escitalopram will be conducted to determine anti-depressant efficacy of adalimumab. Patients will be screened for depression, health concerns, and a minimum of 1.5 pg/mL TNFa. It is hypothesized that adalimumab will lead to improved treatment outcomes (specifically somatic/neurovegetative symptoms). It is hypothesized that, if more symptoms than somatic/neurovegetative respond, they will do so less quickly than somatic/neurovegetative symptoms.
Enrolled participants will be randomized in a 2:1 ratio to adjunctive adalimumab or placebo in addition to the participant's regular dose of escitalopram each day (both conditions). Patients will be matched for sex. Enrolled patients will attend 4 clinic visits, at which point they will receive injections of adalimumab or placebo from the study psychiatrist (Day 1, 15, 29, and 43 for injections), in addition to clinician-assessed measures. Daily self-report assessments of depression symptoms will be collected for 57 days.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 18+ years
- •Meet DSM-5 criteria for Major Depressive Disorder
- •baseline serum TNF-alpha (average of two samples in the same week) greater than 1.5 pg/mL
- •Taking a steady dose of Lexapro (escitalopram) for at least 4 weeks
- •Ability to take oral medication and physician-administered subcutaneous injection and be willing to adhere to the study protocol
- •For females of reproductive potential: use of highly effective contraception for at least 1 month
- •Access to a phone or computer with a camera
排除标准
- •Pregnant or breastfeeding
- •Active, chronic or recurrent infection
- •Known malignancy
- •Current use of immune modulating medications
- •Immunocompromised, current autoimmune condition or history of severe immune condition (e.g., history of cancer, HIV/AIDS)
- •History of, or positive test for, Hepatitis B surface antigen or core antibody positivity or tuberculosis (TB)
- •Congestive heart failure
- •History of demyelinating disease (multiple sclerosis (MS), optic neuritis, Guillain-Barre syndrome)
- •History of seizure disorder
- •Symptomatic hyponatremia
- •Monoamine oxidase inhibitors (MAOI) use within 14 days
- •Recent use of Rituxan (rituximab)
- •Concomitant use of:
- •Immunosuppressants
- •Kineret (anakinra)
- •Orencia (abatacept)
- •Remicade (infliximab)
- •Enbrel (etanercept)
- •Cimzia (certolizumab pegol)
- •Simponi (golimumab)
- •Imuran (azathioprine)
- •Purinethol (6-mercaptopurine)
- •IV methylene blue
- •Antiplatelet agents
- •Strong anticoagulants (e.g. warfarin, large doses of NSAIDs)
- •Other SSRIs, SNRIs, tryptophan
- •Clinically relevant substance use disorder
- •Known allergic reactions to components of adalimumab and/or escitalopram
- •Treatment with another investigational drug or other intervention while participating in the study
研究组 & 干预措施
Placebo Comparison Arm
0.8 mL saline placebo administered on Day 1 subcutaneously, then 0.4 mL saline placebo administered on Days 15, 29, and 43 subcutaneously by study psychiatrist.
干预措施: Placebo (Other)
Active Treatment Arm
80 mg adalimumab administered on Day 1 subcutaneously, then 40 mg adalimumab administered on Days 15, 29, and 43 subcutaneously by study psychiatrist.
干预措施: Adalimumab Biosimilars Injection (Drug)
结局指标
主要结局
Change from baseline in individual somatic, affective, and motivational depressive symptoms, as measured by the Quick Inventory of Depressive Symptomatology (QIDS)
时间窗: From start of trial to the end of study (Day 57)
The QIDS (Trivedi et al., 2004; Rush et al., 2003) is a rating scale that assesses the nine criterion symptom domains designated by the American Psychiatric Association's (2000) DSM-IV to diagnose a major depressive episode. There are 16 items in the adult versions of the QIDS16 measuring the nine criterion symptom domains (sleep, sad mood, appetite/weight, concentration/decision making, self-view, thoughts of death or suicide, general interest, energy level, and restlessness/agitation) that define a major depressive episode according to the DSM-IV. The scores for three domains (sleep, appetite/weight, and restlessness/agitation) are based upon the maximum score (most pathological) of two or more questions for the total score analysis. Each of the remaining domains is rated by a single item. All domains are scored from 0 to 3, with higher scores reflecting greater psychopathology. Source: Yeung, A. et al. (2012). The QIDS. The Journal of nervous and mental disease, 200(8), 712-715.
次要结局
- Change from baseline in the total depression score, as measured by the Quick Inventory of Depressive Symptomatology(From start of trial to the end of study (Day 57))
研究者
Daniel Moriarity
Assistant Professor of Clinical Psychology
University of Pennsylvania