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Scopolamine in Bipolar Depression (SCOPE-BD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04211961
Recruitment Status : Recruiting
First Posted : December 26, 2019
Last Update Posted : May 10, 2021
Sponsor:
Collaborators:
Stanley Medical Research Institute
National University of Ireland, Galway, Ireland
HRB Clinical Research Facility Galway, Ireland
University College Hospital Galway
Information provided by (Responsible Party):
Dr. Brian Hallahan, National University of Ireland, Galway, Ireland

Brief Summary:
This is a single-site, randomised, double-blind, placebo-controlled, parallel, phase IIb clinical trial. The primary objective of the SCOPE-BD study 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

Condition or disease Intervention/treatment Phase
Bipolar Disorder Depression Drug: Scopolamine Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 23, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Placebo Comparator: Control
Participants randomised to the placebo group will receive one 15-minute IV infusion of Saline at 4 visits.
Other: Placebo
The placebo group will receive a 100ml infusion of saline at 4 visits during the study

Active Comparator: Treatment
Participants randomised to the treatment group will receive one 15-minute IV infusion of Scopolamine at 4 visits.
Drug: Scopolamine
The treatment group will receive a 100ml infusion of Scopolamine ( dose 4μg/kg) at 4 visits during the study




Primary Outcome Measures :
  1. Change in Hamilton Depression Rating Scale score [ Time Frame: Visit 3 to Visit 6 (approximately 2 weeks after randomisation) ]
    The primary outcome measure will be the change from Visit 3 (randomisation visit) in severity of objective depressive symptoms after the final scheduled treatment as measured by change in the Hamilton Depression Rating Scale score (range 0-53) from Visit 3 (pre-infusion and randomisation) to Visit 6, with reduced scores indicating an improvement in depressive symptoms and better outcome.


Secondary Outcome Measures :
  1. Remission of depressive episode at Visit 6 by Hamilton Depression Rating Scale [ Time Frame: Approximately 2 weeks after randomisation ]

    Remission of depressive episode after the last IV treatment (measured objectively at Visit 6), and is defined as occurring when an individual has:

    a Hamilton Depression Rating Scale score ≤7 (note range of scores are from 0-53 with lower scores indicating less symptoms of depression and better outcome).


  2. Remission of depressive episode at Visit 6 by Montgomery and Asberg Depression Rating Scale [ Time Frame: Approximately 2 weeks after randomisation ]

    Remission of depressive episode after the last IV treatment (measured objectively at Visit 6), and is defined as occurring when an individual has:

    a Montgomery and Asberg Depression Rating Scale score <6 (note range of scores are from 0-60 with lower scores indicating less symptoms of depression and better outcome).


  3. Remission of depressive episode at Visit 7 by the Hamilton Depression Rating Scale [ Time Frame: Approximately 4 weeks after randomisation (visit 7) ]
    Remission of depressive episode at follow-up (measured objectively at Visit 7) a Hamilton Depression Rating Scale score ≤7 (note range of scores are 0-53 with lower scores indicating less symptoms of depression and better outcome).

  4. Remission of depressive episode at Visit 7 by the Montgomery and Asberg Depression Rating Scale [ Time Frame: Approximately 4 weeks after randomisation (visit 7) ]
    Remission of depressive episode at follow-up (measured objectively at Visit 7) a Montgomery and Asberg Rating Scale score <6 (Note range of scores are from 0-60 with lower scores indicating less symptoms of depression and better outcome).

  5. Improvement in overall functioning utilising the Global Assessment of Functioning Scale [ Time Frame: Approximately 2 weeks after randomisation (Visit 6) ]
    Improvement in objectively measured overall functioning, measured with the Global Assessment of Functioning Scale at Visit 6 (note range of scores are from 0-100, with higher scores indicating better overall functioning and better outcome)

  6. Improvement in overall functioning utilising the Global Assessment of Functioning Scale [ Time Frame: Approximately 4 weeks after randomisation (Visit 7) ]
    Improvement in objectively measured overall functioning, measured with the Global Assessment of Functioning Scale at Visit 7 (note range of scores are 0-100, with higher scores indicating better overall functioning and better outcome).

  7. Improvement in objectively rated illness severity using Clinical Global Impression [ Time Frame: Approximately 2 weeks after randomisation (Visit 6) ]
    Improvement in objectively rated illness severity, measured with the Clinical Global Impression Scale - Improvement at Visit 6 (note range of scores are 1-7, with lower scores (1-3) indicating improved outcome and higher scores (5-7) indicating a worse outcome. A score of 4 indicates no change in symptoms).

  8. Improvement in objectively rated illness severity using Clinical Global Impression [ Time Frame: Approximately 4 weeks after randomisation (Visit 7) ]
    Improvement in objectively rated illness severity, measured with the Clincial Global Impression Improvement Scale at Visit 7 (note range of scores are from 1-7 with lower scores indicating improved outcome).

  9. Change in depressive symptoms with the Profile of Mood Scores [ Time Frame: Post-infusion compared to pre-infusion at each of the 4 visits where infusions are given (baseline, and 4, 8 and 12 days later approximately) ]
    Change in subjective measured depressive symptoms with the Profile of Mood Scores. A reduction in the Profile of Mood Score for depression post-infusion compared to pre-infusion at visits 2 indicates less depressive symptoms and improved outcome (note range of scores are 0-4 with lower scores indicating less depressive symptoms).

  10. Change in total mood disturbance with the Profile of Mood Scores [ Time Frame: Post-infusion compared to pre-infusion at each of the 4 visits where infusions are given (baseline, and 4, 8 and 12 days later approximately) ]
    Change in subjective measured mood disturbance symptoms with the Profile of Mood Scores. A reduction in the Profile of Mood Score for total mood disturbance post-infusion compared to pre-infusion at visits 2 indicates less disturbance of mood symptoms and improved outcome (note range of scores are 0-20) with lower scores indicating lower levels of mood disturbance and improved outcome.

  11. Change in depressive symptoms with the Profile of Mood Scores [ Time Frame: Approximately 2 weeks post-randomsation ]
    Change in subjective measured depressive symptoms with the Profile of Mood Score for depression at follow-up visit 6 (note range of scores are 0-4 with lower scores indicating less depressive symptoms and improved outcome).

  12. Change in depressive symptoms with the Profile of Mood Scores [ Time Frame: Approximately 4 weeks post-randomsation ]
    Change in subjective measured depressive symptoms with the Profile of Mood Scores for Depression at follow-up visit 7 (note range of scores are 0-4 with lower scores indicating less depressive symptoms and improved outcome).

  13. Change in total mood disturbance symptoms with the Profile of Mood Scores [ Time Frame: Approximately 2 weeks post-randomsation ]
    Change in subjective measured mood disturbance symptoms with the Profile of Mood Scores for Depression at follow-up visit 6 (note range of scores are 0-20 with lower scores indicating lower levels of mood disturbance and improved outcome).

  14. Change in total mood disturbance with the Profile of Mood Scores [ Time Frame: Approximately 4 weeks post-randomsation ]
    Change in subjective measured mood disturbance symptoms with the Profile of Mood Scores for Depression at follow-up visit 7 (note range of scores are 0-20 with lower scores indicating lower levels of mood disturbance and improved outcome).

  15. Change in symptoms of anger with the Profile of Mood Scores [ Time Frame: Approximately 2 weeks post-randomisation ]
    Change in subjective measured feelings of anger with the Profile of Mood Scores - Anger at follow-up Visit 6 (note range of scores are 0-4 with lower scores indicating less anger and improved outcome).

  16. Change in symptoms of anger with the Profile of Mood Scores [ Time Frame: Approximately 4 weeks post-randomistion ]
    Change in subjective measured feelings of anger with the Profile of Mood Scores - Anger at follow-up Visit 7 (note range of scores are 0-4 with lower scores indicating less anger and improved outcome).

  17. Change in symptoms of anger with the Profile of Mood Scores [ Time Frame: Post-infusion compared to pre-infusion at each of the 4 visits where infusions are given (baseline, and 4, 8 and 12 days later approximately) ]
    Change in subjective measured feelings of anger with the Profile of Mood Scores - Anger. A reduction in Profile of Mood Score for Anger score post-infusion compared to pre-infusion at visits 2 indicating less anger and improved outcome with range of scores of 0-4).

  18. Change in symptoms of tension with the Profile of Mood Scores [ Time Frame: Post-infusion compared to pre-infusion at each of the 4 visits where infusions are given (baseline, and 4, 8 and 12 days later approximately) ]

    Change in subjective measured symptoms of tension with the POMS - Tension. A reduction in Profile of Mood Scores for tension score post-infusion compared to pre-infusion at visits 2 indicates lower levels of tension and improved outcome with scores ranging from 0-4.

    3, 4 and 5.


  19. Change in symptoms of tension with the Profile of Mood Scores [ Time Frame: Approximately 2 weeks post-randomisation ]
    Change in subjective measured symptoms of tension using the Profile of Mood Scores - Tension at follow-up Visit 6. A reduction in Profile of Mood Scores for tension score post-infusion compared to pre-infusion at visits 2 indicates lower levels of tension and improved outcome with scores ranging from 0-4.

  20. Change in symptoms of tension with the Profile of Mood Scores [ Time Frame: Approximately 4 weeks post-randomisation ]
    Change in subjective measured symptoms of tension using the Profile of Mood Scores - Tension at follow-up Visit 7. A reduction in Profile of Mood Scores for tension score post-infusion compared to pre-infusion at visits 2 indicates lower levels of tension and improved outcome with scores ranging from 0-4.

  21. Change in symptoms of fatigue with the Profile of Mood Scores [ Time Frame: Post-infusion compared to pre-infusion at each of the 4 visits where infusions are given (baseline, and 4, 8 and 12 days later approximately) ]

    Change subjective measured symptoms of fatigue with the Profile of Mood Scores - Fatigue. A reduction in Profile of Mood Scores for fatigue score post-infusion compared to pre-infusion at visits 2 indicates lower levels of fatigue and improved outcome with scores ranging from 0-4.

    3, 4 and 5.


  22. Change in symptoms of fatigue with the Profile of Mood Scores [ Time Frame: Approximately 2 weeks post-randomisation ]
    Change in subjective measured symptoms of fatigue using the Profile of Mood Scores - Fatigue at follow-up Visit 6. A reduction in Profile of Mood Scores for fatigue score post-infusion compared to pre-infusion at visits 2 indicates lower levels of fatigue and improved outcome with scores ranging from 0-4.

  23. Change in symptoms of fatigue with the Profile of Mood Scores [ Time Frame: Approximately 4 weeks post-randomisation ]
    Change in subjective measured symptoms of fatigue at follow-up Visit 7. A reduction in Profile of Mood Scores for fatigue score post-infusion compared to pre-infusion at visits 2 indicates lower levels of fatigue and improved outcome with scores ranging from 0-4.

  24. Change in symptoms of vigour with the Profile of Mood Scores [ Time Frame: Post-infusion compared to pre-infusion at each of the 4 visits where infusions are given (baseline, and 4, 8 and 12 days later approximately) ]
    Changing subjective measured symptoms of vigour with the Profile of Mood Scores. An increase in vigour measured with the Profile of Mood Scores - Vigour score post-infusion compared to pre-infusion at visits 2 indicates higher levels of vigour andimproved outcome, with scores ranging from 0-4.

  25. Change in symptoms of vigour with the Profile of Mood Scores [ Time Frame: Approximately 2 weeks post-randomisation ]
    Change in subjective measured symptoms of vigour at follow-up Visit 6 measured with the Profile of Mood Scores - Vigour. An increase in vigour measured with the Profile of Mood Scores - Vigour score post-infusion compared to pre-infusion at visits 2 indicates higher levels of vigour improved outcome, with scores ranging from 0-4.

  26. Change in symptoms of vigour with the Profile of Mood Scores [ Time Frame: Approximately 4 weeks post-randomisation ]
    Change in subjective measured symptoms of vigour at follow-up Visit 7. An increase in vigour measured with the Profile of Mood Scores - Vigour score post-infusion compared to pre-infusion at visits 2 indicates higher levels of vigour and improved outcome, with scores ranging from 0-4.

  27. Change in symptoms of confusion with the Profile of Mood Scores [ Time Frame: Post-infusion compared to pre-infusion at each of the 4 visits where infusions are given (baseline, and 4, 8 and 12 days later approximately) ]

    Change in subjective measured symptoms of confusion with the Profile of Mood Scores - Confusion. A reduction in Profile of Mood Scores - Confusion score post-infusion compared to pre-infusion at visits 2 indicates lower levels of confusion and improved outcome, with scores ranging from 0-4.

    3, 4 and 5.


  28. Change in symptoms of confusion with the Profile of Mood Scores [ Time Frame: Approximately 2 weeks post-randomisation ]
    Change in subjective measured symptoms of confusion at follow-up Visit 6 measured with the Profile of Mood Scores - Confusion. A reduction in Profile of Mood Scores - Confusion score post-infusion compared to pre-infusion at visits 2 indicates lower levels of confusion and improved outcome, with scores ranging from 0-4.

  29. Change in symptoms of confusion with the Profile of Mood Scores [ Time Frame: Approximately 4 weeks post-randomisation ]
    Change in subjective measured symptoms of confusion at follow-up Visit 7 measured with the Profile of Mood Scores - Confusion. A reduction in Profile of Mood Scores - Confusion score post-infusion compared to pre-infusion at visits 2 indicates lower levels of confusion and improved outcome, with scores ranging from 0-4.

  30. Change in happiness scores with the Visual Analogue Scale [ Time Frame: Post-infusion compared to pre-infusion at each of the 4 visits where infusions are given (baseline, and 4, 8 and 12 days later approximately ]
    A change in subjectively measured levels of happiness as measured with the Visual Analogue Scale for happiness. Higher scores indicate increased happiness and improved outcome, with scores ranging from 0-10.

  31. Change in restlessness symptoms with the Visual Analogue Scale [ Time Frame: Post-infusion compared to pre-infusion at each of the 4 visits where infusions are given (baseline, and 4, 8 and 12 days later approximately ]
    A change in subjectively measured levels of restlessness as measured with the Visual Analogue Scale for Restlessness. Lower scores indicate reduced restlessness and improved outcome, with scores ranging from 0-10.

  32. Change in sadness symptoms with the Visual Analogue Scale [ Time Frame: Post-infusion compared to pre-infusion at each of the 4 visits where infusions are given (baseline, and 4, 8 and 12 days later approximately ]
    A change in subjectively measured levels of sadness as measured with the Visual Analogue Scale for sadness. Lower scores indicate reduced sadness and improved outcome, with scores ranging from 0-10.

  33. Change in anxiety with the Visual Analogue Scale [ Time Frame: Post-infusion compared to pre-infusion at each of the 4 visits where infusions are given (baseline, and 4, 8 and 12 days later approximately ]
    A change in subjectively measured levels of anxiety as measured with the Visual Analogue Scale for Anxiety. Lower scores indicate reduced anxiety and improved outcome, with scores ranging from 0-10.

  34. Change in anger with the Visual Analogue Scale [ Time Frame: Post-infusion compared to pre-infusion at each of the 4 visits where infusions are given (baseline, and 4, 8 and 12 days later approximately ]
    A change in subjectively measured levels of anger as measured with the Visual Analogue Scale for Anger. Lower scores indicate reduced anger and improved outcome, with scores ranging from 0-10.

  35. Change in drowsiness with the Visual Analogue Scale [ Time Frame: Post-infusion compared to pre-infusion at each of the 4 visits where infusions are given (baseline, and 4, 8 and 12 days later approximately ]
    A change in subjectively measured levels of drowsiness as measured with the Visual Analogue Scale. Lower scores indicate reduced drowsiness and improved outcome, with scores ranging from 0-10.

  36. Change in alertness with the Visual Analogue Scale (VAS) [ Time Frame: Post-infusion compared to pre-infusion at each of the 4 visits where infusions are given (baseline, and 4, 8 and 12 days later approximately ]
    A change in subjectively measured levels of alertness as measured with the Visual Analogue Scale for alertness. Higher scores indicate increased alertness and improved outcome, with scores ranging from 0-10.

  37. Number of participants admitted to a psychiatric inpatient unit [ Time Frame: 4 weeks duration (duration of study) ]
    Psychiatric inpatient admission of a participant due to depressive episodes during the trial (Visits 2 to 7)

  38. Change in antidepressant use [ Time Frame: 4 weeks duration (duration of study) ]

    Antidepressants medication use or change by a participant due to depressive episodes over the duration of the study (Visit 2 to Visit 7):

    (i) Introduction of a new antidepressant (yes / no) (ii) Increase in dose of an existing antidepressant (yes / no)


  39. Change in executive function using the Cambridge Neuropsychological Test Automated Battery (CANTAB) [ Time Frame: Approximately 2 weeks after trial commencement ]
    Change in executive functioning using the Cambridge Neuropsychological Test Automated Battery (CANTAB)

  40. Change in visual processing - CANTAB [ Time Frame: Approximately 2 weeks after trial commencement ]
    Change in visual processing the Cambridge Neuropsychological Test Automated Battery (CANTAB)

  41. Change in motor processing - CANTAB [ Time Frame: Approximately 2 weeks after trial commencement ]
    Change in motor processing utilising the CANTAB

  42. Change in emotion recognition - CANTAB [ Time Frame: Approximately 2 weeks after trial commencement ]
    Change in emotion recognition utilising the CANTAB

  43. Occurrence of a hypo (manic) episodes measured by the Young Mania Rating Scale [ Time Frame: Approximately 4 weeks ]
    Occurrence of a hypo (manic) episodes by the YMRS during study

  44. Occurrence of adverse effects - bradycardia [ Time Frame: Over 2 weeks of study infusions ]
    Occurrence of bradycardia - measured at each visit post-infusion

  45. Occurrence of adverse effects - hypotension [ Time Frame: Over 2 weeks of study infusions ]
    Occurrence of hypotension - measured at each visit post-infusion

  46. Occurrence of adverse effects reported by patient [ Time Frame: Over 4 weeks of study ]
    Occurrence of adverse effects reported by patient at visits 2,3,4,5,6,7

  47. Occurrence of adverse effects using Patient Rated Inventory of Side Effects (PRISE) [ Time Frame: Over 2 weeks of study infusions post-randomisation ]
    Occurrence of adverse effects as reported by participants or measured utilising the PRISE questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

To be eligible for inclusion, each participant must meet all of the following inclusion 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. Urea and Electrolytes (U&Es), Liver Function Tests (LFTs) and Thyroid Function Tests (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.

Exclusion Criteria:

Participants who meet any one or more of the following exclusion criteria at Screening (Visit 1) or the 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 investigators 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:

      1. Barrier methods of contraception e.g. Condom
      2. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception
      3. 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.

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): NCT04211961


Contacts
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Contact: Brian Hallahan, Dr. 0035391524222 brian.hallahan@nuigalway.ie

Locations
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Ireland
University Hospital Galway Recruiting
Galway, County Galway, Ireland, H91 YR71
Contact: Irene Garcia Alia    086 008 1175 ext 353    scope-bdcoord@nuigalway.ie   
Principal Investigator: Dr. Brian Hallahan         
Sponsors and Collaborators
Dr. Brian Hallahan
Stanley Medical Research Institute
National University of Ireland, Galway, Ireland
HRB Clinical Research Facility Galway, Ireland
University College Hospital Galway
Publications:

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Responsible Party: Dr. Brian Hallahan, Senior Lecturer and Consultant Psychiatrist, Department of Psychiatry, National University of Ireland, Galway, Ireland
ClinicalTrials.gov Identifier: NCT04211961    
Other Study ID Numbers: NUIG-2017-002
2017-003112-39 ( EudraCT Number )
First Posted: December 26, 2019    Key Record Dates
Last Update Posted: May 10, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Scopolamine
Butylscopolammonium Bromide
Adjuvants, Anesthesia
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Mydriatics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Parasympatholytics