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    Summary
    EudraCT Number:2017-003112-39
    Sponsor's Protocol Code Number:NUIG-2017-002
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-09-04
    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 ConcernedIreland - HPRA
    A.2EudraCT number2017-003112-39
    A.3Full title of the trial
    A Randomised Double-Blinded Placebo-Controlled Trial to Assess the Efficacy and Safety of Scopolamine Compared to Placebo in Individuals with Bipolar Disorder who are Experiencing a Depressive Episode (SCOPE-BD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Trial of Scopolamine Versus Placebo for Individuals with Bipolar Disorder who are Experiencing a Depressive Episode (SCOPE-BD)
    A.3.2Name or abbreviated title of the trial where available
    SCOPE-BD
    A.4.1Sponsor's protocol code numberNUIG-2017-002
    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 SponsorNational University of ireland Galway
    B.1.3.4CountryIreland
    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 supportStanley Medical Research Institute
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHRB Clinical Research Facility Galway
    B.5.2Functional name of contact pointTom Conway
    B.5.3 Address:
    B.5.3.1Street AddressNUI Galway, Newcastle Road
    B.5.3.2Town/ cityGalway
    B.5.3.3Post code0000
    B.5.3.4CountryIreland
    B.5.4Telephone number0861849089
    B.5.6E-mailtconway@nuigalway.ie
    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 Yes
    D.2.1.1.1Trade name Scopolamine (Hyoscine Hydrobromide)
    D.2.1.1.2Name of the Marketing Authorisation holderEthyPharm Group
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameScopolamine (Hyoscine Hydrobromide)
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHyoscine Hydrobromide
    D.3.9.1CAS number 114-49-8
    D.3.9.3Other descriptive nameHYOSCINE HYDROBROMIDE
    D.3.9.4EV Substance CodeSUB14155MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/kg microgram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Bipolar Disorder
    E.1.1.1Medical condition in easily understood language
    Bipolar Disorder
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10004937
    E.1.2Term Bipolar disorder NEC
    E.1.2System Organ Class 100000004873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objective:
    1. The primary objective is to investigate the efficacy and safety of IV Scopolamine, compared to placebo, in reducing severity of depression in individuals with bipolar disorder who are experiencing a depressive episode of at least moderate severity.
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    1. To investigate if IV Scopolamine compared to placebo improves mood, cognition and functioning as measured on a number of objective and subjective psychometric instruments in individuals with bipolar disorder experiencing a depressive episode of at least moderate severity.

    2. To investigate the safety and tolerability of repeated (x3) IV Scopolamine versus placebo in individuals with bipolar disorder experiencing a depressive episode of at least moderate severity.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible each participant must meet all of the following eligibility criteria at Screening (Visit 1) and must continue to fulfil these criteria at Visit 2 to take part in the trial:

    1. Diagnosis of Bipolar Disorder according to Diagnostic Statistics Manual (DSM)-V criteria
    2. Experiencing an episode of depression of at least moderate severity at Visit 1 (Screening) and Visit 2 based on clinical interview by a trained clinician and a Hamilton Depression Rating Scale (HDRS) score ≥ 14.
    3. ≥ 18 years old at Visit 2 (male or female)
    4. In the opinion of the Principal Investigator or Sub Investigator’s, be able and willing to provide written informed consent and to comply with the requirements of this study protocol.
    5. Written informed consent prior to participating in the study
    6. U&Es, LFTs and TFTs laboratory tests within acceptable ranges in the previous 4 months of the Screening Visit (Visit 1).

    Placebo run-in inclusion criteria at Randomisation visit (Visit 3):
    7. In addition to above participants must be experiencing an episode of depression of at least mild severity (having previously experienced an episode of moderate depression at Visit 2 with HDRS ≥ 14), based on clinical interview by a trained clinician and a HDRS score of ≥ 8.
    E.4Principal exclusion criteria
    Participants who meet any one or more of the following exclusion criteria at Screening (Visit 1) or Visit 2 will not be eligible to take part in the trial:

    1. History of other Axis I diagnosis (including Recurrent Depressive Disorder or Psychotic Disorders such as schizo-affective disorder, conditions that can also present with depressive episodes)
    2. History in the three months prior to Visit 2 of alcohol dependence syndrome or substance dependence syndrome.
    3. Current use of oral steroid at Visit 1
    4. A confirmed diagnosis of dementia
    5. A diagnosis of intellectual disability (IQ < 70)
    6. Participants with bipolar disorder that are euthymic in the investigator’s opinion, at screening or Visit 2.
    7. Participants with bipolar disorder that are hypomanic or manic (Young Mania Rating Scale (YMRS) > 6) at screening or Visit 2.
    8. Presence of an established neurological disorder or other serious demyelinating conditions as determined by the treating physician (e.g. space occupying lesion, multiple sclerosis)
    9. Current involuntary detention under the Mental Health Act (MHA) 2001 in an acute psychiatric inpatient unit
    10. Severity of Bipolar Disorder is such that participation in a clinical trial is not appropriate because of the risk of imminent self-harm (based on clinical note review and review at screening visit by experienced clinician)
    11. A history of an allergic reaction or sensitivity to Scopolamine (Hyoscine Hydrobromide). Participants will be asked at the screening visit about any previous treatment with scopolamine (Hyoscine Hydrobromide) to ascertain any previous allergic reaction or sensitivity to this agent.
    12. A clinical diagnosis of narrow angle glaucoma, myasthenia gravis, paralytic ileus, pyloric stenosis, toxic megacolon and acute porphyria.
    13. Individuals will be excluded from the study if currently prescribed anticholinergic medications including Physostigmine, Biperiden and Procyclidine. Individuals will additionally be excluded if currently prescribed Tricyclic Antidepressants which are associated with significant anticholinergic properties (e.g. Amitriptyline and Nortriptyline) that are currently causing the participant to experience anticholinergic side effects (e.g. blurred vision, constipation, urinary retention, cognitive difficulties). No individuals will have anticholinergic medications stopped to allow them enter the trial.
    14. Bradycardia < 50 bpm, tachycardia > 100bpm or hypotension (systolic BP <90 and / or diastolic BP < 60) prior to IV administration of placebo or Scopolamine
    15. A recent history in the last 6 months of symptomatic orthostatic hypotension or syncope.
    16. Previous participation in this trial. Participation is defined as randomised. Participation in another trial within 3 months prior to Visit 1. Receipt of any investigational medicinal product (IMP) within 3 months prior to Visit 1.
    17. Participants concurrently being administered Electroconvulsive Therapy (ECT).
    18. Pregnancy, as determined by a positive urine dipstick at Visits 2, 3, 4, 5, positive blood serum result executed at Visit 2 and confirmed prior to infusion at Visit 3 or participants who are actively breastfeeding (female only).
    19. Women of child-bearing potential are defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of study treatment. Highly effective contraception methods include:
    • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment.
    • Male partner sterilization
    • Combination of any two of the following:
    a. Barrier methods of contraception e.g. Condom
    b. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception
    c. Placement of an intrauterine device (IUD) or intrauterine system (IUS)
    • Women who are considered post-menopausal i.e. amenorrhea at least 12 months or undergone hysterectomy/bilateral oophorectomy
    20. Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator’s opinion, might jeopardise the participant’s safety or compliance with the protocol

    Placebo run-in exclusion criteria at Randomisation visit (Visit 3):
    21. In addition to having completed Visit 2, participants must not be experiencing a hypomanic, or manic episode (YMRS >6).
    22. A Serious Adverse Event (SAE) experienced during infusion which required medical intervention and whereby attending physician deemed it inappropriate for the participant to engage in future infusions.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the change in severity of objective depressive symptoms as measured by change in HDRS score from pre-randomisation (pre-IV infusion on Visit 3) compared to Visit 6.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be the change in severity of objective depressive symptoms as measured by change in HDRS score from pre-randomisation (pre-IV infusion at Visit 3) compared to Visit 6.
    E.5.2Secondary end point(s)
    1. Remission of depressive episode measured with the HDRS at Visit 6 compared to Visit 3.
    2. Response to a depressive episode measured with the HDRS at Visit 6 compared to Visit 3.
    3. Reduction of depressive symptoms (MADRS) at Visit 6 compared to Visit 3.
    4. Improvement in objectively measured overall functioning (GAF) at Visit 6 compared to Visit 3.
    5. Reduction in depressive symptoms as measured using the POMS after all IV infusion visits compared to before IV infusions at the same visit (Visits 2, 3, 4, 5).
    6. Response and remission data measured with the HDRS at Visit 7 compared to pre-randomisation HDRS scores at Visit 3.
    7. Reduction in subjectively measured mood symptoms using the POMS at follow-up visits (Visits 6 and 7) compared to pre-randomisation.
    8. Reduction in depressive symptoms, measured with the MADRS at Visit 7 compared to MADRS scores at Visit 3.
    9. Improvement in global functioning, measured with the GAF at Visit 7 compared to pre-infusion GAF scores at Visit 3.
    10. Psychiatric inpatient admissions due to depressive episodes over the duration of the study.
    11. Antidepressant medication usage or change in antidepressant medication dose due to depressive episodes over the duration of the study.
    12. Adverse events over the duration of the study.
    13. Post infusion side effects at all 3 IV treatment visits: Bradycardia, Hypotension, Dizziness and Sedation (Visits 3, 4 and 5)
    14. Occurrence of a hypo (manic) episode over the duration of the study.
    15. Improvement in motor processing, visual and spatial memory at Visit 6 compared to initial scores measured at Visit 2 or Visit 3 as measured on CANTAB.
    E.5.2.1Timepoint(s) of evaluation of this end point
    These include change in severity of depressive symptoms at study Visits 3, 4, 5, 6 and 7 and changes in cognitive scores at Visit 6
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    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 trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 trial will be the date of the last visit of the last participant (50th randomised participant).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state60
    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)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-09-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-08
    P. End of Trial
    P.End of Trial StatusOngoing
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