SNAPPER
Research type
Research Study
Full title
A stratified randomised controlled trial to evaluate the clinical and cost-effectiveness of Stimulant compared with Non-stimulant medication for adults with Attention-deficit/hyperactivity disorder and a history of Psychosis or biPolar disordER
IRAS ID
1003970
Contact name
Steven Marwaha
Contact email
Eudract number
2021-000302-21
ISRCTN Number
ISRCTN79796233
Research summary
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. The aim is to recruit 648 patients in total (324 with ADHD and bipolar and 324 with ADHD and psychosis,) from UK hospitals. Patients will undergo screening to confirm their ADHD and psychosis or bipolar diagnosis, then will be entered into the main trial to receive the randomly allocated medication. Doctors will carefully assess patients at every 1-2 weeks at first to see if the medication is working, whether they are on the right dose and for side effects. After agreeing to take part, and at 6 & 12 months, patients will be asked to complete self-report questionnaires and interviews with the researcher. The questionnaires will measure ADHD symptoms, day-to-day functioning, quality of life, use of health services and whether new symptoms of psychosis or bipolar emerge. The study will take 58 months to complete.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
21/SW/0172
Date of REC Opinion
14 Jan 2022
REC opinion
Further Information Favourable Opinion