ISRCTN48548553已完成3 期
A randomised placebo-controlled trial on the effectiveness of escitalopram and nortriptyline for depressive symptoms in Parkinson’s disease.Substudy on the effectiveness of nortriptyline to delay motor progression in Parkinson’s diseasewith depressive symptoms compared to placebo.
niversity College London0 个研究点目标入组 52 人开始时间: 2019年2月22日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
研究概览
简要总结
2022 Protocol article in https://doi.org/10.1186/s12883-022-02988-5 (added 27/04/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 27/04/2023:
- •1. Patients with a diagnosis of idiopathic PD, based on a history and neurological exam performed by the enrolling investigator with presence of at least two of the three cardinal signs of PD: rigidity, bradykinesia, and rest tremor with no evidence of diagnostic alternatives.
- •2. Aged 18 years old or above
- •3. Fulfilling operationally defined subsyndromal depression (presence of two or more depressive symptoms at threshold or subthreshold levels, at least one of which had to include depressed mood or anhedonia or diagnostic (DSM-V) criteria for a depressive disorder (i.e. major depressive disorder or persistent depressive disorder)).
- •4. Beck Depression Inventory-II (BDI-II) score =14.
- •5. Written informed consent provided.
- •6. Treatment with antiparkinsonian medication is optimised or stable for at least 4 weeks before date of randomisation and there are no plans to change up to primary endpoint (8 weeks).
- •Previous inclusion criteria:
- •1. Patients with a diagnosis of idiopathic PD, based on a history and neurological exam performed by the enrolling investigator with presence of at least two of the three cardinal signs of PD: rigidity, bradykinesia, and rest tremor with no evidence of diagnostic alternatives
- •2. Aged 18 to 85 years
- •3. Fulfilling diagnostic (DSM-V) criteria for a depressive disorder (i.e., major depressive disorder or persistent depressive disorder) or operationally defined subsyndromal depression (presence of two or more depressive symptoms at threshold or subthreshold levels, at least one of which has to include depressed mood or anhedonia
- •4. Beck Depression Inventory-II (BDI-II) score > = 14 5. Written informed consent provided
排除标准
- •Current exclusion criteria as of 27/04/2023:
- •1. Women who are pregnant, breastfeeding or of childbearing potential without effective contraception (hormonal or barrier method of birth control; or abstinence). Periodic abstinence (e.g.calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- •2. Patients who do not have sufficient understanding of the English language to be or are not able to understand the Patient Information Sheet or the self-completed questionnaires or patients who are unable to communicate answers to the self-rating questionnaires.
- •3. Patients with Montreal Cognitive Assessment (MoCA) score <16 or without capacity to consent.
- •4. Treatment with an antidepressant within 4 weeks of enrolment (except for a small dose of amitriptyline up to 30 mg for indications other than depression).
- •5. Patients with known severe liver failure.
- •6. Absolute contraindications to escitalopram or nortriptyline. These include:
- •a. Patients with known QT-interval prolongation57 or congenital long QT syndrome.
- •b. Recent myocardial infarction (<3 months), any degree of heart block or other cardiac arrhythmias precluding treatment with nortriptyline or escitalopram according to clinical judgement.
- •7. Medications contraindicated on nortriptyline or escitalopram. These include:
- •a. Non-selective and selective irreversible monoamine oxidase inhibitors (MAOIs) within 14 days. However, the antiparkinsonian selective reversible MAO-B inhibitors rasagiline, selegiline and safinamide are not contraindicated.
- •b. Concomitant QT prolonging drugs, including domperidone, apomorphine at high doses (single dose or hourly rate of >6mg), certain neuroleptics (not quetiapine or clozapine), quinine, class IA and III antiarrhythmics (amiodarone, dronedarone and disopryamide), the antihistamines astemizole, mizolastine, the antimicrobial agents sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarian treatment), and some antiretrovirals.
- •8. Patients indicating active suicidal ideation or intent on the BDI-II item 9 and who, after clinical review of risk using the standardised Suicide Risk Management Protocol, need to be referred for immediate treatment.
- •9. Participation in another clinical trial of an investigational medicinal product or device within the last 30 days of randomisation.
- •10. Any clinical condition which in the opinion/ clinical judgement of the investigator would make the patient unsuitable for the trial due to safety concerns.
- •Previous exclusion criteria:
- •1. Women who are pregnant, breastfeeding or of childbearing potential without effective contraception (hormonal or barrier method of birth control; or abstinence)
- •2. Patients who do not have sufficient understanding of the English language to be able to read and understand the self-completed questionnaires or patients who are unable to communicate answers to the self-rating questionnaires
- •3. Patients with Montreal Cognitive Assessment (MoCA) score < 16 or without capacity to consent
- •4. Treatment with an antidepressant within 4 weeks of enrolment (except for a small dose of amitriptyline up to 50 mg for indications other than depression)
- •5. Absolute contraindications to escitalopram or nortriptyline. These include: a. Patients with known QT-interval prolongation or congenital long QT syndrome. b. Recent myocardial infarction, any degree of heart block or other cardiac arrhythmias
- •6. Medications contraindicated on nor
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