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Clinical Trials/EUCTR2018-002942-35-GB
EUCTR2018-002942-35-GB
Active, not recruiting
Phase 1

A Randomised Controlled Trial of Escitalopram and Nortriptyline compared with placebo and standard psychological care for depression in Parkinson’s Disease - Antidepressants Trial in Parkinson's Disease (ADepT-PD)

niversity College London Comprehensive Clinical Trials Unit0 sites408 target enrollmentSeptember 5, 2019
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ConditionsDepression in Parkinson's diseaseMedDRA version: 20.0Level: PTClassification code 10012378Term: DepressionSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 20.0Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
DrugsNortriptyline

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Depression in Parkinson's disease
Sponsor
niversity College London Comprehensive Clinical Trials Unit
Enrollment
408
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 5, 2019
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversity College London Comprehensive Clinical Trials Unit

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Not specified

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