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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Francesca
Moruzzi
francesca.k.moruzzi@kcl.ac.uk
Dr
Grainne
McAlonan
grainne.mcalonan@kcl.ac.uk
Disorders of psychological development
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
The brain depends on the balance between the major excitatory (E) chemical glutamate and inhibitory (I) chemical GABA. Autism spectrum disorders (ASD) are a group of related conditions including autism and Asperger’s syndrome. Recent research suggests that there may be differences in the E-I system in people with and without ASD; and this is especially true for GABA. We want to test this theory and find out more about how E-I systems may be altered in ASD.
To do this we will measure glutamate, GABA, and brain activity in adults with and without ASD when the E-I system is active and when it is ‘resting’. To do so we will carry out MRI (magnetic resonance imaging) brain scans and tests out-of-the-scanner when the GABA system is briefly activated by a single dose of a GABA-acting drug (AZD7325) and when the GABA system is resting after a 'dummy pill' (placebo).
AZD7325 acts at the same nerve target as the body’s own GABA therefore it helps us understand what GABA does in the brain. AZD7325 has been used in Clinical Trials and found to be generally safe and well tolerated, therefore it is a useful research tool for our study.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Case-controlled study;
You can take part if:
You may not be able to take part if:
For all participants: 1. History of allergy/idiosyncrasy to AZD7325 or chemically related compounds or excipients which may be employed in the study or to any other drug used in the past. 2. Subject has taken systemically (po, iv) any potent or moderate CYP3A4 or CYP2C9 inhibitor or inducer, 1 month prior to screening (topical or inhaled are permitted) such as: aprepitant, barbiturates, carbamazepine, clarithromycin, erythromycin, cyclosporine, diltiazem, efavirenz, fluconazole, HIV protease inhibitors, glucocorticoids, itraconazole (oral/IV), ketoconazole, nefazodone, nevirapine, phenytoin, pioglitazone, primidone, rifabutin, rifampicin, telithromycin, St. John's wort, verapamil. 3. Clinically relevant history or presence of any medical disorder, potentially interfering with this study. 4. Clinically relevant abnormality at screening as judged by the investigator. 5. History of or current abuse of drugs (including prescription medication) or alcohol or solvents. 6. Participation in an research study involving a pharmacological probe or drug trial within last month or more than four in the previous 12 months 7. Subjects with a history of epilepsy, seizures or episodes of unexplained and unprovoked loss of consciousness. 8. Anyone with a history or examination which indicates laboratory testing is needed will be excluded from the study. 9. Intelligence Quotient below 70. Reproductive safety Male study participants who are sexually active should avoid procreation for 1 week after study drug administration. Avoidance of procreation can be through use of a highly effective contraception method by the study participant or by the partner. In this case, effective means of contraception are defined as tubal occlusion, copperbanded intrauterine device, levonorgestrel medicated intra uterine system (e.g., Mirena), medroxyprogesterone injections (e.g. Depo-Provera), etonogestrel implants (e.g., Implanon, Norplan), normal and low dose combined oral contraceptive pills, norelgestromin / EE transdermal system, intravaginal device (e.g., EE and etonogestrel) and desogestrel (Cerazette). Pregnancy or breastfeeding (is a routine exclusion for research MRI scanning). Female study participants must be willing to use one form of highly effective non-hormonal contraception for one week after study drug administration. This would include a vasectomised partner (sole partner), tubal occlusion, intrauterine system [IUS]/hormonal coil or copper containing intrauterine device or copper containing IUD, or true abstinence (when this is in line with the preferred and usual lifestyle of the subject). Women should have been stable on their chosen method of birth control for a minimum of 2 months before entering the study. Participants must agree to undergo a pregnancy test prior to each administration of study drug. For individuals with ASD: ASD caused by a known genetic syndrome, e.g. Fragile X, 22q11 deletion syndrome. Currently treated for epilepsy.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by King's College London and funded by European Commission .
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for Trial ID: CPMS 38858
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