Attention-Deficit/Hyperactivity Disorder (ADHD) and a history of either psychosis or bipolar disorder Mental and Behavioural Disorders
Conditions
Interventions
Current interventions as of 06/03/2025:
Patients will randomised to receive either Lisdexamfetamine (stimulant) initiated at 30mg once daily, and increased to a maximum of 70mg once daily for 6 mont
OR Atomoxetine (non-stimulant) initiated at 40mg daily, and increased to a maximum of 100mg daily for 6 months
Randomisation will be provided by a secure online randomisation system at the Birmingham
OR Atomoxetine (non-stimulant) initiated at 40mg daily, and increased to a maximum of 100mg daily for 12 months (if on Fluoxetine then starting dose should be halved e.g., 20mg if weight > 70kg).
Ra
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 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 informed consent _____ Previous inclusion criteria: 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 and on suitable mood stabilisers or antipsychotics 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 informed consent
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 06/03/2025: 1. ADHD medication contra-indicated 2. 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 syndrome 5. History of epilepsy or seizures 6. 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 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 age 11. 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-indicated 2. 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 syndrome 5. History of epilepsy or seizures 6. 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 age 11. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 06/03/2025: ADHD symptoms at 6 months measured using the Conners Adult ADHD Rating Scale-Observer (CAARS-O) total score _____ Previous primary outcome measure: ADHD symptoms at 12 months measured using the Conners Adult ADHD Rating Scale-Observer (CAARS-O) total score | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 06/03/2025: 1. Clinical (ADHD symptoms using CAARS-O total score at 12 months, emergence of hypomania/mania symptoms, emergence of psychotic symptoms and depression over 12 months; emotional dysregulation at 6 and 12 months). 2. Quality of life (QOL) (ADHD specific QOL for participants only using the Adult ADHD QOL (AADHD QOL); health-related QOL and capability wellbeing for both the participant and supporter (close person) at 6 and 12 months) using the EQ-5D-5L and ICECAP-A. 3. Occupational and functional outcomes (occupational and daily functioning, employment, education at 6 and 12 months) using the Functioning Assessment Short Test (FAST). 4. Substance misuse (problem drug use, problem drinking at 6 and 12 months). 5. Adherence at 6 months (Medication Adherence Rating Scale (MARS) 6. Process outcomes (all causes for discontinuation of treatment). 7. Resource use (modified Client Service Receipt Inventory (CSRI) and use of acute services at 6 and 12 months). 8. Concomitant medication use (type, dose and duration) at 6 and 12 months. _____ Previous secondary outcome measures: 1. Clinical (ADHD symptoms using CAARS-O total score at 6 months, emergence of hypomania/mania symptoms, emergence of psychotic symptoms and depression over 12 months; emotional dysregulation at 6 and 12 months). 2. Quality of life (QOL) (ADHD specific QOL for participants only using the Adult ADHD QOL (AADHD QOL); health-related QOL and capability wellbeing for both the participant and supporter (close person) at 6 and 12 months) using the EQ-5D-5L and ICECAP-A. 3. Occupational and functional outcomes (occupational and daily functioning, employment, education at 6 and 12 months) using the Functioning Assessment Short Test (FAST). 4. Substance misuse (problem drug use, problem drinking at 6 and 12 months). 5. Adherence at 6 and 12 months (Medication Adherence Rating Scale (MARS) and self-reported adherence at, 6, and 12 months; pill counting on pr | — |
Countries
England, United Kingdom
Outcome results
None listed