Cocktail Phenotypic Approach to Explore Antidepressant Pharmacokinetic Variability: a Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- CYP2D6 activity
研究概览
简要总结
We propose here to explore systematically the association between drug-metabolizing enzymes activity assessed by a phenotypical approach and antidepressant plasma concentration, efficacy and tolerance in the clinical setting. During one year, patients receiving antidepressant will be included in tis prospective clinical, naturalistic and descriptive pilot study.
详细描述
- Objectives To describe drug metabolism variability in depressive patients using a phenotypic approach
- Study design Prospective, clinical, naturalistic, descriptive study During a consultation with their clinician, depressive patients will receive information.
During the visit V0 with an investigator: patients will be included:
- Verification of inclusion and non inclusion criteria
- Reminder participation conditions
- Inclusion, signature of consent
- Collection of clinical and demographic features Between V0 and V1, for patients with change in antidepressant therapy, will take place telephone interviews every two weeks, conducted by the clinician to evaluate treatment depression response (tolerance and efficacy)
During the visit V1, will take place:
- Phenotypic study
- Genetic study
- Dosage of current antidepressant drug
- Clinical evaluation: efficacy and tolerance
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with clinical diagnosis of depression and decision to change antidepressant therapy (augmentation or switch) OR Patients with clinical diagnosis of depression and stability of prescription since almost 6 weeks
- •Male and female aged from 18 to 70 years
- •Volunteers to participate to the study
- •Understanding of French language and able to give a written inform consent.
排除标准
- •Renal or hepatic impairment (Clearance below 60mL/min, AST or ALT over 3N) Sensitivity to any of the substrate drugs used ECG showing long QT interval (>0.46sec) No antidepressant dosage available Current pregnancy or desire to get pregnant
- •Criteria to perform V1 Sufficient compliance between V0 and V1 Six weeks period without change in antidepressant therapy
研究组 & 干预措施
Overall population
干预措施: Omeprazole (10 mg, A02BC01) (Drug)
结局指标
主要结局
CYP2D6 activity
时间窗: >two hours after an oral intake of the cocktail probe drugs
dextrorphan / dextromethorphan
CYP2C9 activity
时间窗: >two hours after an oral intake of the cocktail probe drugs
4-hydroxyflurbiprofen/ flurbiprofen
CYP2B6 activity
时间窗: >two hours after an oral intake of the cocktail probe drugs
4-hydroxybupropion/ bupropion
CYP2C19 activity
时间窗: >two, three and six hours after an oral intake of the cocktail probe drugs
5-hydroxyomeprazole/ omeprazole
P-gp activity
时间窗: >two, three and six hours after an oral intake of the cocktail probe drugs
Limited sampling fexofenadine AUC
CYP1A2 activity
时间窗: >two hours after an oral intake of the cocktail probe drugs
paraxanthine/caffeine
CYP3A4 activity
时间窗: >two hours after an oral intake of the cocktail probe drugs
1-hydroxymidazolam/ midazolam
次要结局
- Antidepressant tolerance(almost 6 weeks after the last treatment change)
- Antidepressant Concentration(almost 6 weeks after the last treatment change)
- Antidepressant efficacy(almost 6 weeks after the last treatment change)
研究者
Celia Lloret-Linares
Doctor
University Hospital, Geneva