2024-513907-15-01招募中3 期
Precision psychiatry: Anti-inflammatory medication in Immuno-metabolic depression
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Inventory of Depressive Symptomatology (IDS, 30-item self-report) total score during 12 week follow-up
研究概览
简要总结
To evaluate whether a 12-week celecoxib treatment (400mg/day) added to treatment as usual (TAU, defined as pharmacotherapy and/or psychotherapy) is more effective in reducing depressive symptoms as measured with the Inventory of Depressive Symptomatology (IDS 30-item self-report version) than placebo in patients aged 18-65yr with major depressive disorder and IMD characteristics (atypical, energyrelated symptoms (≥6 on IDS)(Lamers et al. 2020) and circulating CRP>1mg/L) during 12-week follow-up.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years
- •DSM-5 diagnosis of MDD confirmed with clinical interview (MINI)
- •Currently using pharmacotherapy (SSRI, SNRI, TCA, TetraCA, MAOI, other antidepressants [bupropion, vortioxetine, agomelatine]) and/or psychotherapy. Subjects should be on the current treatment for at least 4 weeks
- •IDS score ≥26 and a score ≥6 on atypical, energy-related symptoms scale from IDS
- •A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: o Is not a woman of child bearing potential (WOCBP) o Is a WOCBP and agrees to use, or is already using, a contraceptive method during the intervention period and up to 1 month after the intervention
- •signed informed consent
排除标准
- •Contraindications for celecoxib (active peptic ulcers, gastrointestinal bleeding, impaired kidney function (creatinine clearance < 30 ml/min), impaired liver function (ALT > 2x upper limit of normal [ULT]), history of ischemic heart disease or stroke, heart failure, allergic reactions to aspirin/NSAIDs/coxibs, use of anticoagulants
- •ECT in the past 3 months
- •Being on other psychotropic drugs
- •Clinically overt alcohol/drug dependence or other primary psychiatric diagnoses (schizophrenia, schizoaffective, OCD, or bipolar disorder)
- •Chronic use of anti-inflammatory drugs and corticosteroids
- •Not speaking Dutch
结局指标
主要结局
Inventory of Depressive Symptomatology (IDS, 30-item self-report) total score during 12 week follow-up
Inventory of Depressive Symptomatology (IDS, 30-item self-report) total score during 12 week follow-up
次要结局
- Functioning (WHO-DAS)
- Pain (numeric rating scale)
- Therapy compliance
- response (50% reduction in IDS score)
- remission (diagnostic interview)
- Adverse side effects
- Symptom profiles (atypical, energy-related symptoms IDS)
- Fatigue (CIS)
- Food craving (GFCQ-T)
- Sleep and sleep duration (ESS, sleep duration from PSQI)
- Anxiety symptoms (GAD7)
- Change in blood levels of CRP, IL-6, TNF-α, cholesterol, triglycerides,glucose
研究者
Femke Lamers
Scientific
Amsterdam UMC Stichting
研究点 (1)
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