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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.
Prof
Steven
Marwaha
-
S.Marwaha@bham.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Attention-Deficit/Hyperactivity Disorder (ADHD) and a history of either psychosis or bipolar disorder
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.
Attention-Deficit/Hyperactivity Disorder (ADHD) is a common mental disorder that involves problems with attention, overactivity, acting impulsively. ADHD starts in childhood and commonly persists into adulthood commonly occurring alongside psychosis or bipolar disorder (bipolar), both severe mental illnesses. ADHD in adulthood is treated with medication of which there are two types: stimulants, (recommended to be used first), or nonstimulants. Doctors are concerned and uncertain about how effective and safe medications for ADHD are in people who also have psychosis or bipolar. Currently, there is not much evidence to help clinicians and patients in deciding which medication can best be prescribed. The study will try to understand which type of medication is most effective in reducing symptoms of ADHD in these patients, how safe the medications are. The design of the study is called a “randomised controlled trial”, which is the best way to find out the answer to this type of scientific problem.
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:
You can take part if:
Current inclusion criteria as of 06/03/2025:
1. Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) based on the Diagnostic Interview for ADHD in Adults-5 (DIVA-5)
2. Psychosis (schizophrenia spectrum disorders) (Strata 1) OR Bipolar disorder (Strata 2) diagnosis according to the DSM-5 based on the Mini International Neuropsychiatric Interview (MINI)
3. Stable in the opinion of the clinical investigator
4. Males and females aged 18 years and over
5. Not currently (or within the last month) on medication for ADHD
6. Able to give written info
You may not be able to take part if:
Current exclusion criteria as of 06/03/2025:
1. ADHD medication contra-indicated2. Currently in an acute episode of psychosis or bipolar disorder3. Severe suicide risk or severe risk of violence to others4. Severe drug seeking behaviour or a current drug/alcohol withdrawal syndrome5. History of epilepsy or seizures6. Congenital or acquired long QT syndrome (LQTS); OR family history of QT prolongation; OR on medication associated with increased risk of QT interval prolongation such as class IA and III anti-arrhythmics,moxifloxacin,erythromycin,methadone,mefloquine,tricyclic antidepressants or cisapride.7. Currently taking CYP2D6 inhibitors (other than Fluoxetine, Doxepin, Duloxetine, Haloperidol, Paroxetine, Promethazine, Risperidone, Trazadone or Venlafaxine) as these are routinely used in the target population, and clinically accounted for in prescribing ADHD medication dosing and scheduling.8. Participating in another conflicting/incompatible clinical trial9. Females of child-bearing age only:10. Pregnant. Note: Spot urine test will be performed at screening and/or randomisation to rule out pregnancy in females of child-bearing age11. Not willing to take highly effective contraceptive measures to prevent pregnancy during study participation period AND for 30 days following administration of the last trial medication dose.
_____
Previous exclusion criteria:
1. ADHD medication contra-indicated2. Currently in an acute episode of psychosis or bipolar disorder 3. Severe suicide risk or severe risk of violence to others 4. Severe drug seeking behaviour or a current drug/alcohol withdrawal syndrome5. History of epilepsy or seizures6. Congenital or acquired long QT syndrome (LQTS); OR family history of QT prolongation; OR on medication associated with increased risk of QT interval prolongation such as class IA and III anti-arrhythmics,moxifloxacin,erythromycin,methadone,mefloquine,tricyclic antidepressants or cisapride.7. Currently taking CYP2D6 inhibitors e.g.,quinidine,terbinafine.8. Participating in another interventional or conflicting/incompatible clinical trial 9. Females of child-bearing age only:10. Pregnant. Note: Spot urine test will be performed at screening and/or randomisation to rule out pregnancy in females of child-bearing age11. Not willing to take highly effective contraceptive measures to prevent pregnancy during study participation period AND for 30 days following administration of the last trial medication dose.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Prof
Steven
Marwaha
-
S.Marwaha@bham.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University of Birmingham and funded by NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC).
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 49907
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
