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    Summary
    EudraCT Number:2018-002942-35
    Sponsor's Protocol Code Number:CTU/2017/285
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-09-05
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2018-002942-35
    A.3Full title of the trial
    A Randomised Controlled Trial of Escitalopram and Nortriptyline compared with placebo and standard psychological care for depression in Parkinson’s Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomised Controlled Trial of Escitalopram and Nortriptyline compared with placebo, and standard psychological care, for depression in Parkinson’s disease
    A.3.2Name or abbreviated title of the trial where available
    Antidepressants Trial in Parkinson's Disease (ADepT-PD)
    A.4.1Sponsor's protocol code numberCTU/2017/285
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN48548553
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03652870
    A.5.4Other Identifiers
    Name:ClinicalTrials.gov Number:NCT03652870
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity College London Comprehensive Clinical Trials Unit
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNational Institute for Health Research - Health Technology Assessment
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity College London Comprehensive Clinical Trials Unit
    B.5.2Functional name of contact pointChief Investigator
    B.5.3 Address:
    B.5.3.1Street AddressUpper Third Floor, Royal Free Hospital, Rowland Street
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeNW3 2PF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number020 7794 0500
    B.5.6E-maila.schrag@ucl.ac.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEscitalopram
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEscitalopram oxalate
    D.3.9.1CAS number 219861-08-2
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.1.1.1Trade name Nortriptyline
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNortriptyline
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNortriptyline hydrochloride
    D.3.9.1CAS number 72-69-5
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Depression in Parkinson's disease
    E.1.1.1Medical condition in easily understood language
    Depression in Parkinson's disease
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10012378
    E.1.2Term Depression
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061536
    E.1.2Term Parkinson's disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Establish the clinical-effectiveness and cost-effectiveness of escitalopram at 8 weeks compared to placebo in the treatment of depression in PD, in addition to standard psychological care in the NHS.

    Establish the clinical-effectiveness and cost-effectiveness of nortriptyline at 8 weeks compared to placebo in the treatment of depression in PD, in addition to standard psychological care in the NHS.
    E.2.2Secondary objectives of the trial
    Establish whether there is a difference in adverse reactions between escitalopram and nortriptyline.

    Establish the long-term (1 year) clinical effectiveness and cost-effectiveness of escitalopram and nortriptyline compared to placebo in the treatment of depression in PD, in addition to standard psychological care.

    Establish the clinical effectiveness of escitalopram and of nortriptyline compared to placebo on anxiety and other secondary outcome measures.

    Establish whether after one year of treatment parkinsonism has deteriorated less in patients with PD with depressive disorder on nortriptyline than on placebo.

    Establish whether after one year of treatment parkinsonism has deteriorated more in patients with Parkinson’s disease with depression on escitalopram than on placebo.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    ADepT-PD genetic sub-study (optional), version 1.0, dated XXX.
    The genetic sub-study requires a blood sample to be taken for genetic analysis preferably at screening/baseline or at a later trial visit. The aim of the ADepT-PD genetic sub-study is to try to identify genetic markers that may be associated with subtypes of PD (e.g. presence of depression and anxiety) or variation in treatment responsiveness. The primary aim of this resource and of future work will be to enable targeting of the best treatments to specific patient groups.
    E.3Principal 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
    E.4Principal 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

    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure for the trial is, at 8 weeks of treatment, depressive symptoms measured using the Beck Depression Inventory (BDI-II) to assess clinical effectiveness against placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 8 weeks of treatment.
    E.5.2Secondary end point(s)
    At 8, 26 and 52 weeks of treatment:

    Patient-reported outcomes
    •Level of depression as measured using the Becks Depression Inventory (BDI-II) (at weeks 26 and 52).
    •Level of depression on the Patient Health Questionnaire 9(PHQ9) at weeks 8, 26 and 52.
    •Number of participants experiencing side effects (adverse events) on the Modified Toronto Side Effects Scale and reporting of other adverse events.
    •Overall clinical effectiveness on the Global Clinical Impression scale (CGI) - change in health question.
    •Anxiety symptoms on the Parkinson Anxiety Scale.
    •Quality of life on the EQ-5D-5L questionnaire and the ICECAP capability measure.
    •Health and social care resource use on the modified Client Service Receipt Inventory (CSRI).
    •Changes in concomitant medication.
    •Participant’s trial medication guess (antidepressant or placebo).

    Clinician and patient-reported outcomes
    •Motor and non-motor experiences on the MDS-UPDRS Part I and II, and motor examination and motor complications on the MDS-UPDRS Part III and IV. Motor severity will also be video-recorded for rating by the central trial team.

    Clinician-reported outcomes
    •Cognitive function assessed on the Montreal Cognitive Assessment (MoCA).
    •Clinician’s trial medication guess.
    •Levodopa-equivalence dose.
    •Number of drop-outs.

    Carer-reported outcomes (if participant has a carer)
    •Carer’s quality of life using the EQ-5D-5L and Carers Quality of Life Questionnaire for Parkinsonism.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 8, 26 and 52 weeks of treatment.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned30
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the trial for individual participants will be the date of their last visit. Trial closure is defined as the date when all data has been received, cleaned and all queries resolved at all sites.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 204
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 204
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state408
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 408
    F.4.2.2In the whole clinical trial 408
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    If a participant wishes to continue to receive the trial medication at the end of the trial, the site staff will liaise with the participant's GP to continue prescription following unblinding.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-10-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-15
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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