Imaging 5HT7 antagonist effects in bipolar disorder
Research type
Research Study
Full title
Translational validation of 5HT7 antagonists as a treatment for cognitive impairment in bipolar disorder: a proof of principle neuroimaging study
IRAS ID
240244
Contact name
Paul Stokes
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Bipolar disorder (BD) is a serious mental health problem in which people experience repeated episodes of depression and elated mood. BD affects around 1.2 million people in the UK and costs around £5.2 billion per year. Around 60% of people with BD experience problems with attention and memory, known as cognitive impairment, which greatly affects the ability to work and hold relationships. Currently there are no effective drug treatments for cognitive impairment in BD. However, drugs which block a type of brain receptor, the 5HT7 receptor, may be a promising new treatment. The main aim of this study is to understand the effect of the medication JNJ-18038683, which specifically blocks the 5HT7 receptor, on brain activity and cognitive performance. We will examine the effect of JNJ-18038683 in people with BD who experience cognitive impairment and in healthy people. We will recruit 34 people with BD and 34 healthy people. After being screened for suitability, each person will complete a series of attention and memory tests. They will then take 20mg JNJ-18038683 for one week and will be switched to placebo for one week, or vice versa, with a two week drug-free period in between. Neither participants nor study staff will know which medication has been taken. Brain activity will be measured using magnetic resonance imaging (MRI) which produces detailed images of the structure and function of the brain. We will examine how JNJ-18038683 and placebo affect brain activity and cognitive performance during an MRI scan on day 7 of each treatment period by asking participants to complete cognitive tasks in the scanner. We will assess whether JNJ-18038683: (i)changes brain activity during these tasks, (ii)normalises brain activity in people with BD; and (iii)improves cognitive performance. We hope that these results will support the development of larger clinical treatment studies.
REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
18/LO/0762
Date of REC Opinion
2 Jul 2018
REC opinion
Further Information Favourable Opinion