2022-501692-35-00招募中3 期
INSTA-MD: INflammation-based Stratification for immune-Targeted Augmentation in Major Depressive disorder
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- Change in severity of depression measured as change in the HDRS-17 between baseline and endpoint
研究概览
简要总结
Validate the efficacy of immune-targeted augmentation with minocycline or celecoxib in a Flemish cohort of patients with MDD who failed to remit with one or two trials of antidepressant treatment
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18-65 years inclusive
- •Able and willing to give informed consent and take oral medication
- •Physically healthy
- •Diagnosis of Major Depressive Disorder by DSM-5 criteria, confirmed by the Mini International Neuropsychiatric Interview (MINI)
- •The current episode of depression has failed to remit to the current antidepressant treatment at the adequate dose (as defined in the Maudsley Prescribing guidelines). Relapse while taking an antidepressant is also considered a treatment failure
- •Tolerant to the current antidepressant and having no planned changes in their current therapy for the duration of the study.
- •Stable on current treatment for a minimum of 4 weeks (6 weeks for fluoxetine) prior to baseline.
- •If female and of childbearing age, willing to use adequate contraceptive precautions and willing to take pregnancy tests.
- •A score of 14 or higher on the Hamilton Depression Rating scale (HDRS-17)
排除标准
- •Primary diagnosis of bipolar disorder, psychotic spectrum disorder, obsessive-compulsive disorder, eating disorder, post-traumatic stress disorder, or alcohol and/or substance use dependence according to DSM-5 (< 4 weeks before screening, excl. nicotine and caffeine)
- •Serology positive for hep-B surface antigen, hep-C antibodies or HIV antibodies
- •Received ECT < 2 months prior to screening
- •The current episode of depression has failed to remit after three trials of antidepressant treatment.
- •Blood donation in 30 days prior to screening
- •Concomitant penicillin or anticoagulant therapy
- •Pregnancy or breastfeeding
- •Being diagnosed with Familial Adenomatous Polyposis (FAP).
- •Having an acute infection in the last two weeks, neutrophilia or leukocytosis at screening (i.e. neutrophils ≥ 10 x10^9 /L or white blood cell count ≥ 12 x10^9 /L)
- •Currently enrolled in an intervention study
- •Use of immunosuppressant or immunostimulant drugs within 21 days of screening (e.g., glucocorticoid treatment, methotrexate, etc.)
- •History of peptic ulcer disease or gastrointestinal (GI) bleeding
- •Having an acute infection or having an inflammatory bowel disorder.
- •Current severe cardiovascular disease (e.g. congestive heart failure (NYHA-class II–IV), ischemic or thrombotic events or unstable coronary artery (incl. coronary artery bypass graft (CABG) surgery))
- •Use of (Vitamin K) anticoagulant therapy
- •Having received >14 days of tetracycline or NSAID within the previous 2 months, or having a history of sensitivity or intolerance to this classes of drugs
- •Chronic severe hypertension (systolic BP > 170 mmHg)
结局指标
主要结局
Change in severity of depression measured as change in the HDRS-17 between baseline and endpoint
Change in severity of depression measured as change in the HDRS-17 between baseline and endpoint
Rates of remission (HDRS≤7) at endpoint
Rates of remission (HDRS≤7) at endpoint
次要结局
- Change in severity (IDS-30SR) Change in severity of depression measured as change in the IDS-30SR score [Time Frame: T0 -> T6 (12 weeks)]
- Response rate (HDRS-17) Rates of response (50% reduction in HDRS score from baseline) or partial response (25% reduction) at endpoint [Time Frame: T0 -> T6 (12 weeks)]
- Sleep (PSQI) [Time Frame: T0 -> T6 (12 weeks)]
- Anxiety (STAI) [Time Frame: T0 -> T6 (12 weeks)]
- Metabolic outcomes BMI, waist circumference, triglyceride, cholesterol, HDL and LDL levels, and fasting glucose [Time Frame: T0 -> T6 (12 weeks)]
- Symptom profiles (IDS-SR) [Time Frame: T0 -> T6 (12 weeks)]
- Therapy compliance (MARS) [Time Frame: T0 -> T6 (12 weeks)]
- Adverse effects [Time Frame: T0 -> T6 (12 weeks)]
- biomarker outcomes: cytokine concentrations, oxidative stress and metabolic markers
- Core assessment of psychomotor change (CORE) [Time Frame: T0 -> T6 (12 weeks)]
研究者
Manuel Morrens
Scientific
University Of Antwerp
研究点 (4)
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