SCOPE-BD

SCOPE-BD

Interested in taking part in the SCOPE-BD study?

Please contact: Ruán Kane (ruan.kane@nuigalway.ie; 086 008 1175)

 Main Criteria

• Diagnosis of Bipolar Disorder
• Currently experiencing a depressive episode or low mood symptoms

 What is the SCOPE-BD Study?

SCOPE-BD is a study investigating a treatment for depression in people with Bipolar Disorder. Unlike conventional antidepressants, this treatment is fast-acting and does not pose the same risk of causing patients to become elated or “manic.” The medication in is called Scopolamine, and is widely used for a variety of medical applications, including motion sickness, postoperative nausea and muscle spasms. Research has shown that Scopolamine can exert positive effects on mood when given intravenously.^1,2

Participating in the study involves attending University Hospital Galway for 4 visits at which participants are given an intravenous (IV) infusion (otherwise known as a “drip”) lasting 15 minutes. There will be a number of physical, mood and cognitive assessments done also – this will be useful to keep track of mood scores between each visit. While this is not a paid trial, we will reimburse any travel, and if necessary, accommodation costs you might incur as part of your participation.

About the Trial

SCOPE-BD is a randomised, double-blind, placebo-controlled clinical trial. “Placebo-controlled” means that participants will receive either the study medication or a placebo (e.g., saline). This is necessary to prove the efficacy of the treatment so that it can eventually be made available to the members of the public at large. “Double-blind” means that both you and the researchers interacting with you will not know whether you receive the study drug or placebo. This is important to reduce the risk of bias. “Randomised” means that you will be sorted into the treatment or placebo groups at random, meaning that everyone has an equal chance to receive the study drug.

This study is led by Consultant Psychiatrist and NUIG Senior Lecturer, Dr. Brian Hallahan, with the research grant funded by the Stanley Medical Research Institute. This study will be conducted at NUIG’s Clinical Research Facility based in University Hospital Galway. The SCOPE-BD study has received ethical approval from the Health Products Regulatory Authority (HPRA) as well as NUIG’s Research Ethics Committee (REC).

Why Participate?

By participating in the study you may benefit from the treatment itself as well as having the opportunity to gain insights from tracking your mood for the study duration. Moreover, you will be making an invaluable contribution to the development of new treatments, potentially helping generations to come.

Please note that this study is completely voluntary and you may withdraw your consent and information at any time. All measures will be taken to protect your personal privacy. Your data will be anonymised and data collected will be in line with GDPR guidelines.

For any other queries or to enrol in the study, please contact Ruán Kane (clinical researcher) at ruan.kane@nuigalway.ie or 086 008 1175.

 References

Furey, M. L. & Drevets, W. C. Antidepressant efficacy of the antimuscarinic drug scopolamine: a randomized, placebo-controlled clinical trial. Arch Gen Psychiatry 63, 1121-1129 (2006). https://doi.org:10.1001/archpsyc.63.10.1121

Drevets, W. C. & Furey, M. L. Replication of scopolamine's antidepressant efficacy in major depressive disorder: a randomized, placebo-controlled clinical trial. Biol Psychiatry 67, 432-438 (2010). https://doi.org:10.1016/j.biopsych.2009.11.021