2023-509680-25-00招募中4 期
A New Intervention for Implementation of Pharmacogenetics in Psychiatry
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 820
- 试验地点
- 3
- 主要终点
- Patient recovery at 24 weeks, as assessed using the patient recovery assessment scale (RAS, RAS-DS))
研究概览
简要总结
Compare individualised medication dosing based on pharmacogenetics in psychiatric patients with dosing as usual
研究设计
- 分配方式
- Randomized
- 主要目的
- Allocation of patients
- 盲法
- Double (Investigator, Subject)
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Suffer from a depressive episode (major depressive disorder and bipolar disorder (currently depressive episode)) (as assessed by the MINI in agreement with DSM-5 criteria) of at least moderate severity (assessed using the Structured Interview Guide for the Hamilton Depression Scale (SIGH-D) with a score of 14 or higher) and/or suffer from an anxiety disorder (for example panic disorder, social phobia, specific phobia, agoraphobia, generalised anxiety disorder) (as assessed by the MINI in agreement with DSM-5 criteria) of at least moderate severity (assessed using the Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) with a score of 18 or higher) and/or suffer from a psychotic disorder (schizophrenia and schizoaffective disorder) (as assessed by the MINI in agreement with DSM-5 criteria) of at least moderate severity (assessed using the Positive and Negative Symptom Scale (PANSS) with a score of 75 or higher)
- •Have had an inadequate response to at least 1 psychotropic treatment during their life-time. Inadequate response is defined as insufficient efficacy of a psychotropic treatment when dosed high enough and maintained long enough, or discontinuation of a psychotropic treatment due to AEs or intolerability
- •Are about to switch (or have switched within the last 2 weeks prior to first contact with an investigator) to sertraline or escitalopram (for patients with mood or anxiety disorders), or to aripiprazole or risperidone (for patients with psychotic disorders) due to an inadequate response to or intolerance of the current/ previous medication.
- •Currently receiving inpatient or outpatient psychiatric treatment
- •Be able to understand the requirements of the study and provide written informed consent to participate in this study; a signed and dated informed consent form (ICF) will be obtained from each patient before any procedure of the study.
- •To give written consent to the use and disclosure of clinical data from their medical records for the purpose of this study
- •Age between ≥18and <65 years
- •Women of child-bearing potential must have a negative pregnancy test in serum/urine before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: intrauterine device, bilateral tubal occlusion,vasectomized partner and sexual abstinence. Hormonal contraceptive methods is accepted because there are no additional risk for this trial.
排除标准
- •Patients with a history of prior pharmacogenomic testing
- •Patients with no prior use of psychotropic medication (medication-naïve patients)
- •Severe somatic comorbidities as reported in the subject’s medical history or based on clinical chemistry/electrocardiography (ECG) results up to six months ago. If any of these comorbidities is detected on the basis of physical examination and/or clinical chemistry and/or ECG at the screening visit, participation is not possible: Liver disease defined as follows: Alanine-Aminotransferase (ALAT) >70u/L; Renal disease defined as: Estimated glomerular filtratrion rate (eGFR) < 60mL/min/1.73m2; Uncontrolled diabetes considering screening blood tests (Blood glucose > 11.1 mmol/L or two timestwice fasting glucose > 7.0 mmol/L); Cardiac disease defined as: prolonged QT-interval
- •Alcohol and/or substance abuse and/or dependence (except nicotine) , allowing mild substance/ alcohol use disorder (as assessed by the MINI in agreement with DSM-5 criteria).
- •Polypharmacy defined as the routine use of five or more medications including over-the-counter, prescription and/or traditional and complementary medicines used by a patient (WHO 2019) , excluding the study medication.
- •Pregnant or breastfeeding women
结局指标
主要结局
Patient recovery at 24 weeks, as assessed using the patient recovery assessment scale (RAS, RAS-DS))
Patient recovery at 24 weeks, as assessed using the patient recovery assessment scale (RAS, RAS-DS))
次要结局
- Well-being and quality of life (EuroQol 5 Dimensions-5 levels questionnaire; EQ-5D-5L). Psychosocial functioning (Functioning Assessment Short Test (FAST)). Clinical symptomatology (SIGH-D; for patients with mood disorders), (SIGH-A; anxiety disorders), and the PANSS (for psychotic patients). Side effects (Frequency, Intensity and Burden of side effects ratings (FIBSER) and the Udvalg for Kliniske Undersogelse – Side Effects Rating Scale (UKU-SERS)). Obtained over a 24-week period
研究者
Prof. R. van Westrhenen
Scientific
Parnassia Groep B.V.
研究点 (3)
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