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Scopolamine in Bipolar Depression

NCT04211961 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2025-04-29

Study results available
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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

Interventions

OTHER

Placebo / Saline

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

DRUG

Scopolamine

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

Sponsors & Collaborators

  • Stanley Medical Research Institute

    collaborator OTHER

  • National University of Ireland, Galway, Ireland

    collaborator OTHER

  • HRB Clinical Research Facility Galway

    collaborator OTHER

  • University College Hospital Galway

    collaborator OTHER

  • Dr. Brian Hallahan

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-23
Primary Completion
2024-02-22
Completion
2024-02-22

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04211961 on ClinicalTrials.gov