Scopolamine in Bipolar Depression

NCT04211961 | Completed Phase 2 Results DMC

• 2 other identifiers: NUIG-2017-0022017-003112-39
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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

Conditions

Bipolar Disorder Depression

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale Score After Last Treatment

  Severity of objective depressive symptoms after the final scheduled treatment (Visit 6) as measured by the Hamilton Depression Rating Scale score. Possible scale range is 0-54, with higher values indicating greater severity of Depression.

  Approximately 2 weeks after randomisation (Visit 6)

Secondary Outcomes (13)

• Remission of Depressive Episode After Last Treatment (Visit 6)

  Approximately 2 weeks after randomisation (Visit 6)

• Remission of Depressive Episode at Followup (Visit 7)

  Approximately 4 weeks after randomisation (visit 7)

• Response to a Depressive Episode After the Last IV Treatment (Visit 6)

  Approximately 2 weeks after randomisation (visit 6)

• Remission of Depressive Episode at Followup

  At the time of followup at Visit 7, about 4 weeks after randomisation

• Montgomery-Åsberg Depression Rating Scale Score After Last Treatment (Visit 6)

  After last treatment (Visit 6), about 2 weeks after randomisation

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants randomised to the placebo group will receive one 15-minute IV infusion of 100ml Saline at 4 visits.

Other: Placebo / Saline

Scopolamine

ACTIVE COMPARATOR

Participants randomised to the Scopolamine/treatment group will receive one 15-minute IV infusion of Scopolamine at 4 visits.

Drug: Scopolamine

Interventions

Placebo / Saline OTHER

The placebo group will receive a 100ml infusion of saline at 4 visits during the study

Placebo

Scopolamine DRUG

The treatment group will receive a 100ml infusion of Scopolamine ( dose 4μg/kg) at 4 visits during the study

Scopolamine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Bipolar Disorder according to Diagnostic Statistics Manual (DSM)-V criteria
• 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.
• ≥ 18 years old at Visit 2 (male or female)
• 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.
• Written informed consent prior to participating in the study
• 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).
• 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.

You may not qualify if:

• 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)
• History in the three months prior to Visit 2 of alcohol dependence syndrome or substance dependence syndrome.
• Current use of oral steroid at Visit 1
• A confirmed diagnosis of dementia
• A diagnosis of intellectual disability (IQ \< 70)
• Participants with bipolar disorder that are euthymic in the investigators opinion at screening or Visit 2.
• Participants with bipolar disorder that are hypomanic or manic (Young Mania Rating Scale (YMRS) \> 6) at screening or Visit 2.
• Presence of an established neurological disorder or other serious demyelinating conditions as determined by the treating physician (e.g. space occupying lesion, multiple sclerosis)
• Current involuntary detention under the Mental Health Act (MHA) 2001 in an acute psychiatric inpatient unit
• 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)
• 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.
• A clinical diagnosis of narrow angle glaucoma, myasthenia gravis, paralytic ileus,pyloric stenosis, toxic megacolon and acute porphyria.
• 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.
• Bradycardia \< 50 bpm, tachycardia \> 100bpm or hypotension (systolic BP \<90 and / or diastolic BP \< 60) prior to IV administration of placebo or Scopolamine
• A recent history in the last 6 months of symptomatic orthostatic hypotension or syncope.

Sponsors & Collaborators

• Dr. Brian Hallahan: lead
• Stanley Medical Research Institute: collaborator
• National University of Ireland, Galway, Ireland: collaborator
• HRB Clinical Research Facility Galway: collaborator
• University College Hospital Galway: collaborator

Study Sites (1)

University Hospital Galway

Galway, County Galway, H91 YR71, Ireland

Location

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MeSH Terms

Conditions

Bipolar Disorder

Interventions

Sodium Chloride; Scopolamine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Dr. Alberto Alvarez-Iglesias
• Organization: University of Galway

alberto.alvarez-iglesias@universityofgalway.ie

+35391524411

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Lecturer and Consultant Psychiatrist, Department of Psychiatry

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 26, 2019
• Study Start: March 23, 2021
• Primary Completion: February 22, 2024
• Study Completion: February 22, 2024
• Last Updated: April 29, 2025
• Results First Posted: April 29, 2025

Record last verified: 2025-04

Locations

IE (1)