What is the study about?
Medications which block a type of brain chemical receptor, called the 5HT7 receptor, may be a promising new treatment for cognitive impairment experienced by people with bipolar disorder. This study aims to examine how JNJ-18038683 might affect brain activity produced by cognition and mood tasks in both people with bipolar disorder and healthy adults. The effects of JNJ-18038683 will be investigated by giving participants a week-long dose of 20mg of JNJ-18038683 or placebo capsule before a brain scan called a magnetic resonance imaging (MRI) scan. The participants will be asked to perform thinking and mood tasks whilst being scanned.
What does participation in the study involve?
This study will include four visits to the IoPPN.
You will be asked to attend a screening session lasting approximately two hours to ensure that you are suitable to take part in the study. This visit will include some questions about your medical and mental health history, physical examination, blood sampling and some questionnaires about your personality. If you are eligible, the study will involve a further three visits. The next visit will be a baseline visit lasting approximately 2.5 hours, where we will repeat the physical examination to ensure your health hasn’t changed and you’re still able to participate. Women of childbearing potential will also have a urine pregnancy test. Again, you will complete some questionnaires about your mood, and some tests of your memory, attention, and concentration with a researcher. At the end of this visit, you will be provided with the first week of study medication and a study diary. We will ask you to use the study diary to record that you have taken the medication and whether you experienced any side effects.
The next two visits will be imaging visits taking place on the seventh day of taking the study medications (JNJ-18038683 or placebo), each lasting about 4.5 hours. Again, we will do a brief physical examination, blood sampling and some questionnaires. On one visit you will receive JNJ-18038683 and on the other you will receive the placebo. You will then be asked to have an MRI scan which will last about 1 hour 15 mins. While in the scanner you will be asked to complete some computer tasks designed to test your memory and emotional processing.
Following the scan, a doctor will carry out a brief physical examination and you will then go home as long as the study clinician has decided that it is safe for you to leave. Three weeks later, on day seven of your second course of study medications, you will be invited to attend the centre again where we will ask you to complete the same procedures as in the previous scanning day visit.
What could make you ineligible for the study?
The following reasons are likely to mean you can’t take part in the study:
- If you have, or have had, any serious medical or neurological condition
- If you have a current, or past history of major psychiatric disorder (with exception of bipolar disorder for participants with bipolar disorder
- If you are currently taking certain medications (please see list at the bottom of the page)
- If you are allergic to JNJ-18038683 or other medications with 5HT7 antagonist properties such as lurasidone (Latuda) or vortioxetine (Trintellix)
- If you have taken part in a research study involving administration of an experimental drug within the last three months or plan to do so up to two weeks after the study
- If you take recreational drugs
- If you have any metallic or electronic objects in your body, e.g. pacemaker, cochlear ear implants, fixed dental braces
- If you are claustrophobic or cannot lie still in an MRI scanner for a period of around 1 hour 15 mins
- For women: if you are currently not using an effective contraceptive method, plan to get pregnant in the next three months, or if you are currently pregnant or breast feeding
- For people with bipolar disorder: if there is likely to be a change in dose or type of your regularly prescribed mental health medications the month before the screening visit or a likely change during your participation in the study
Will you be compensated for your time?
You will be paid £200 to compensate you for your time if you complete the study. We will also reimburse reasonable travel expenses and provide you with lunch during the scanning sessions.
Summary of findings
Excluded medications for participants
Participants who currently take the following medications will be excluded from the study:
alprenolol, amitriptyline, amphetamine, aripiprazole, atomoxetine, bufuralol, carisoprodol, carvedilol, chloramphenicol, chlorpheniramine, chlorpromazine, citalopram, clomipramine, clonidine, clopidogrel, codeine, cyclophosphamide, debrisoquine, desipramine, dexflenfluramine, dextromethorphan, diazepam, donepezil, duloxetine, encainide, esomprazole,flecainide, fluoxetine, fluvoxamine, haloperidol, hexobarbital, imipramine, indomethacin, isocarboxazid, labetalol, lansoprazole, lidocaine, lurasidone, methoxyamphetamine, metoclopramide, mexilletine, minaprine, moclobemide, nebivolol, nelfinavir, nilutamide, norphenytoin, nortriptyline, omeprazole, ondansetron, oxycodone, pantoprazole, paroxetine, perhexiline, perphenazine, phenacetin, phenelzine, phenformin, phenobarbitone, phenytoin, primidone, progesterone, proguanil, promethazine, propafenone, propafenone, propranolol, propranolol, R-mephobarbital, rabeprazole, risperidone, S-mephenytoin, S-metoprolol, sparteine, tamoxifen, teniposide, thioridazine, timolol, tramadol, tranylcypromine, venlafaxine, voriconazole, vortioxetine, warfarin, zuclopenthixol.
Participants planning to use these medications after their participation in the study must commit to a two-week washout period at the end of the study before commencing these medications.