A clinical trial to investigate how effective a stimulant medication is compared to a non-stimulant medication in patients who have been diagnosed with attention deficit hyperactivity disorder (ADHD) and also have a history of either psychosis or bipolar disorder

Plain English summary of protocol

Background and study aims
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.

Who can participate?
Adults over 18 years, with a diagnosis of ADHD.

What does the study involve?
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.

What are the possible benefits and risks of participating?
Benefits:
• If eligible, then patients taking part in the trial may start their treatment sooner than if they did not enter the trial
• All patients will receive either one of the 2 interventions studied as there is no placebo in the study.
• There is usually more time for patients to discuss their health and their condition and patients feel they may play a more active role in their own healthcare
• Patients are monitored more closely by the clinical team than if they did not take part in the trial
• The study provides costs towards the prescription for trial medication
• There are monetary incentives for completing the study assessments
• Travel costs towards each assessment visit are covered for all patients taking part

Risks:
We would not expect any safety issues for participants. The trial medications being used have long established safety profiles, have been used for a long time in treating ADHD in patients with psychosis or bipolar. Participants will be monitored closely and if at any time symptom severity is presented by the participant, their clinical care team will assess them and decide if they need to change the medication dose or stop taking the trial medication. There is no known risk to female partners of patients taking either drugs but the manufacturer's advise is to avoid pregnancy and breast-feeding whilst on medication. As such, we will screen female participants for pregnancy (excluding those confirmed pregnant) and monitor for pregnancies throughout the duration of the trial intervention. Additionally, female patients of child-bearing age will be asked to take appropriate contraceptive measures to avoid pregnancy during trial treatment.

Where is the study run from?
University of Birmingham (UK)

When is the study starting and how long is it expected to run for?
January 2021 to May 2026

Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).

Who is the main contact?
Shrushma Loi, snapper@trials.bham.ac.uk

Contact information

Prof Steven Marwaha
Principal investigator

Institute for Mental Health
School of Psychology
College of Life and Environmental Sciences
University of Birmingham
Rm 219, 52 Pritchatts Road
Edgbaston
Birmingham
B15 2TT
United Kingdom

ORCID ID	0000-0002-0303-9942
Email	S.Marwaha@bham.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• United Kingdom
• England

Study participating centres

Results and Publications

Study outputs

Editorial Notes

07/11/2025: Publication reference added.
06/03/2025: The following changes were made to the trial record:
1. The scientific title was changed from "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" to "A 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".
2. The overall end date was changed from 30/10/2025 to 30/05/2027.
3. The interventions were changed.
4. The primary outcome measures were changed.
5. The secondary outcome measures were changed.
6. The inclusion criteria were changed.
7. The target number of participants was changed from 648 to 244.
8. The exclusion criteria were changed.
9. The recruitment end date was changed from 28/02/2025 to 30/05/2026.
10. The study participating centres Cheshire and Wirral Partnership NHS Foundation Trust, Avon and Wiltshire Mental Health Partnership NHS Trust, Berkshire Healthcare NHS Foundation Trust were added.
11. The plain English summary was updated to reflect these changes.
12. The intention to publish date was changed from 31/10/2026 to 31/05/2027.
06/11/2023: South London & Maudsley NHS Trust Hq, South West London & St George’s Mental Health Trust, Norfolk and Suffolk NHS Foundation Trust, NHS Lanarkshire, Forward Thinking Birmingham and Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust were added to the study participating centres.
26/04/2022: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).