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A 6-week Randomised, Double-Blind, Placebo-Controlled, Multicentre Study to Evaluate the Efficacy of Lurasidone Adjunctive Therapy in Improving Cognitive Functioning in Euthymic Bipolar Disorder Patients (ELICE-BD)

What is the study about?

People with bipolar disorder can have various symptoms of cognitive (thinking) impairments, even when their mood symptoms are stabilised. These impairments have shown to influence other aspects of life, such as work and general quality of life. Finding ways to prevent the persistence of these impairment are therefore of high importance, however very little research has addressed this yet.

Lurasidone is a type of antipsychotic medication, both licensed and approved in the UK. It has been linked with improvement of depressive symptoms and cognition in people with schizophrenia. Smaller studies have already found promising results on Lurasidone’s effect in people with bipolar disorder, but this would be the largest study to date to investigate its potential in improving cognition.

The aim of the ELICE-BD study is to compare the difference in cognitive functioning in people treated with Lurasidone vs. placebo, to observe if the active treatment has any influence on cognitive functioning, as well as if Lurasidone influences mood symptoms.

The ELICE-BD is a large multi-centre international study spanning over several continents.

What to expect from participation in the study

This is a short study of only 6 weeks of treatment and up to 12 weeks in total of study participation, including your screening assessment and follow-ups.

The first assessment will be a screening, where we determine if you are eligible to participate. If you are and willing, then you will be assigned to receive either Lurasidone or a placebo. This will be decided by a computer - neither you nor we know what you will be assigned. This is what we call a double-blind randomised study. You will be able to continue your usual medical treatment regardless of which study group you are assigned.

You will then over the following 6 weeks be required to attend 3 face-to-face appointments, where we will do various cognitive tests, such as test your memory, attention, and speed of thinking, as well as assess your medical and psychiatric history, physical examination, and blood tests. In addition, you will have 4 telephone assessments for a thorough monitoring of your mood and wellbeing, including how you are responding to the treatment.

As with all studies at King’s College London, your participation is completely voluntary and withdrawal at any stage is always a possibility without it affecting your regular treatment.

Benefits of taking part

Cognitive impairment is an additional burden for many with bipolar disorder, an illness which already impacts people’s lives severely. Lurasidone already shows potential to be a positive factor in both treatment of mood symptoms and improving cognitive functioning, but a big study has not yet been done to demonstrate this thoroughly. Your participation in this research will help new guidelines to be drawn about the potential of Lurasidone for future treatment of bipolar disorder.

Your participation in this study will also allow your own cognitive functioning to be thoroughly tested, something that many people find interesting. It may provide you with some insight into your own illness profile, such as why you have trouble remembering things or are able to do some thinking-required activities, but not others. Cognitive impairments, both persistent and sporadic, are very common for people with bipolar disorder and does not mean low intelligence but is a feature of this mental illness. You might find Lurasidone to help you improve this and see it benefit your own life.

Inclusion criteria

To be eligible for participation in the study, you must be between 19 and 65 years old and have a diagnosis of bipolar disorder type 1 or 2 (with or without previous manic episodes), without any additional severe anxiety or ADHD disorders, and currently in a stable mood status which is not manic, hypomanic, or depressed. This will be determined at the screening session, so don’t worry too much now whether this criterion applies to you.

For this study, we also need you to be willing and able to attend the in-person assessments, consisting mainly of cognitive testing, which we can’t do over the phone. Having the Covid-19 pandemic in mind, we understand the difficulties this might cause, and we want to assure you that we are doing everything we can to keep the assessments safe for both you and us.

Finally, you need to be willing to receive Lurasidone treatment, as well as not having any contraindications of this medication. This will be assessed at the screening session, along with all other inclusion and exclusion criteria.

Other similar studies for people with bipolar disorder

Project status: Ongoing

Contact

ELICE-BD research team
Centre for Affective Disorders
King’s College London