A Randomised Controlled Trial of Escitalopram and Nortriptyline compared with placebo, and standard psychological care, for depression in Parkinson’s disease

Phase 1

• Conditions: Depression in Parkinson's disease; MedDRA version: 20.0Level: PTClassification code 10012378Term: DepressionSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 20.0Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2018-002942-35-GB
• Lead Sponsor: niversity College London Comprehensive Clinical Trials Unit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-05
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 408

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

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 204
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 204

Exclusion Criteria

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 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 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 prolongation (defined here as >420ms) or congenital long QT syndrome.
b.Recent myocardial infarction, any degree of heart block or other cardiac arrhythmias.

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. Treatment with antiparkinsonian medication is not optimized and stable within 4 weeks of receiving the trial medication and there are plans to change up to primary endpoint (8 weeks)

10. Enrolment in another clinical trial of an investigational medicinal product or device within the last 30 days

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified