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Trial record 55 of 531 for:    ESCITALOPRAM AND Disorders

Antidepressants Trial in Parkinson's Disease (ADepT-PD)

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ClinicalTrials.gov Identifier: NCT03652870
Recruitment Status : Not yet recruiting
First Posted : August 29, 2018
Last Update Posted : September 5, 2018
Sponsor:
Collaborators:
London North West Healthcare NHS Trust
King's College London
University Hospital Plymouth NHS Trust
NHS Lothian
Information provided by (Responsible Party):
University College, London

Brief Summary:
This is a randomised trial in a NHS setting, comparing the clinical effectiveness and cost-effectiveness of the selective serotonin reuptake inhibitor, escitalopram, and of the tricyclic antidepressant, nortriptyline, to placebo, undertaken in a real-life setting in addition to standard psychological care for the treatment of patients with depression in Parkinson's disease. Participants will be randomly allocated 1:1:1 to receive escitalopram or nortriptyline or placebo.

Condition or disease Intervention/treatment Phase
Depression Parkinson Disease Drug: Nortriptyline Drug: Escitalopram Drug: Placebo Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 408 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blind
Primary Purpose: Treatment
Official Title: A Randomised Placebo-Controlled Trial of Escitalopram and Nortriptyline With Standard Psychological Care for Depression in Parkinson's Disease
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : December 1, 2022


Arm Intervention/treatment
Active Comparator: Nortriptyline
25mg tablet to be escalated from one tablet per day to a maximum of 4 tablets per day
Drug: Nortriptyline
A medication used to treat conditions such as depression
Other Name: Nortriptyline 25mg

Active Comparator: Escitalopram
5mg tablet to be escalated from one tablet per day to a maximum of 4 tablets per day
Drug: Escitalopram
A medication used to treat conditions such as depression
Other Name: Escitalopram 5mg

Placebo Comparator: Placebo
The placebo tablet consists of lactose and magnesium stearate. One tablet to be escalated from one tablet per day to a maximum of 4 tablets per day
Drug: Placebo
Lactose and magnesium stearate tablet to be used as a placebo.
Other Name: Placebo oral tablet




Primary Outcome Measures :
  1. Depressive symptoms [ Time Frame: 8 weeks ]
    Measured using the Beck Depression Inventory II to assess the severity of depression


Secondary Outcome Measures :
  1. Level of depression [ Time Frame: 26 and 52 Weeks ]
    Measured using Beck Depression Inventory II to assess the severity of depression

  2. Severity of depression [ Time Frame: 8, 26 and 52 Weeks ]
    Measured using Patient Health Questionnaire 9 to monitor the severity of depression and response to treatment

  3. Number of patients suffering side effects [ Time Frame: 8, 26 and 52 Weeks ]
    Measured using the Toronto side effects scale which records symptoms specific to depression.

  4. Number of participants suffering side effects [ Time Frame: 8, 26 and 52 Weeks ]
    Measured using reporting of other adverse events not reported on the Toronto side effects scale.

  5. Overall clinical effectiveness [ Time Frame: 8, 26 and 52 Weeks ]
    Measured using the Global Clinical Impression scale - change in health question to rate the severity of the patient's illness.

  6. Anxiety symptoms [ Time Frame: 8, 26 and 52 Weeks ]
    Measured using the Parkinson's Anxiety Scale (PAS) to measure anxiety in patients with Parkinson's disease

  7. Capability [ Time Frame: 8, 26 and 52 Weeks ]
    Measured using ICECAP to measure the patient's capability

  8. Self-rated health score [ Time Frame: 8, 26 and 52 Weeks ]
    Measured using EQ-5D-5L to measure the patients' health score on the day of assessment

  9. Health and social care resource [ Time Frame: 8, 26 and 52 Weeks ]
    Measured using modified Client Service Receipt Inventory (CSRI) to collect information on the whole range of services and supports patients may use

  10. Changes in concomitant medication [ Time Frame: 8, 26 and 52 Weeks ]
    Measured using concomitant medication logs

  11. Motor and non-motor experiences [ Time Frame: 8, 26 and 52 Weeks ]
    Measured using the Movement Disorder Society - Unified Parkinson's Disease Rating Scale to assess both motor and non-motor symptoms associated with Parkinson's disease

  12. Cognitive function [ Time Frame: 8, 26 and 52 Weeks ]
    Measured using Montreal Cognitive Assessment (MoCA) to assess for mild cognitive dysfunction

  13. Levodopa equivalence dose [ Time Frame: 8, 26 and 52 Weeks ]
    Measured using concomitant medication logs to calculate the contribution made by each of the patient's Parkinson's drugs, using, as a common denominator, an estimate of the levodopa equivalent dose

  14. Number of drop outs [ Time Frame: 8, 26 and 52 Weeks ]
    Measured using recruitment logs to determine the number of patients who did not complete the study to the end of study treatment

  15. Carer's self-rated health score [ Time Frame: 8, 26 and 52 Weeks ]
    Measured using EQ-5D-5L to measure the carer' health score on the day of assessment

  16. Carer reported quality of life [ Time Frame: 8, 26 and 52 Weeks ]
    Measured using Carers Quality of Life Questionnaire for Parkinsonism to assess the quality of life of carers of patients with Parkinson's disease



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with a diagnosis of idiopathic Parkinson's Disease, based on a history and neurological exam performed by the enrolling investigator with presence of at least two of the three cardinal signs of Parkinson's Disease: rigidity, bradykinesia, and rest tremor with no evidence of diagnostic alternatives. Patients who have been treated with levodopa must have demonstrated a clear response.
  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

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 not able 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
  6. Medications contraindicated on nortriptyline or escitalopram. These include:

    1. 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
    2. 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
  7. 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
  8. Treatment with antiparkinsonian medication should be optimized and stable within 4 weeks of screening and with no plans to change up to primary endpoint (8 weeks)
  9. Participation in another clinical trial of an investigational medicinal product or device within the last 30 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652870


Contacts
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Contact: Kate Maclagan, BSc, PhD 02035495015 k.maclagan@ucl.ac.uk
Contact: Helen Knowles, BSc, PhD 02031087878 h.knowles@ucl.ac.uk

Sponsors and Collaborators
University College, London
London North West Healthcare NHS Trust
King's College London
University Hospital Plymouth NHS Trust
NHS Lothian
Investigators
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Principal Investigator: Anette Schrag University College, London

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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT03652870     History of Changes
Other Study ID Numbers: 18/0279
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University College, London:
Parkinson's Disease

Additional relevant MeSH terms:
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Depressive Disorder
Parkinson Disease
Mood Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Citalopram
Dexetimide
Depression
Behavioral Symptoms
Nortriptyline
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents