Current condition as of 22/01/2021: Specialty: Mental Health, Primary sub-specialty: Learning disorders
Conditions
Interventions
Current interventions as of 22/01/2021:
Participants will be randomised to receive 8-weeks treatment with either OROS-MPH or placebo, titrated over 5 weeks to balance ADHD symptom improvement against
Week 2 = 36 mg (2 tablets)
Week 3 = 54 mg (3 tablets)
Week 4 = 72 mg (4 tablets)
Week 5 = 72 mg (4 tablets)
Week 6 = 72 mg (4 tablets)
Week 7 = 72mg (4 tablets)
Week 8 = 72mg (4 tablets). Titration of dose is conducted by the study psychiatrist. Both the trial investigators and participants are blinded. The titration protocol is followed in the same way for b
Sponsors
King's College London
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 22/01/2021: 1. Male, aged between 16 and 25 years 2. English speaking 3. Able to provide informed consent (understand the information sheet and make an informed decision taking into account pros and cons of study participation) 4. Meet clinical diagnostic criteria for DSM-5 ADHD: 5 or more current symptoms of ADHD in either the inattentive or hyperactive-impulsive symptom domains; 6 or more symptoms of ADHD in either the inattentive or hyperactive/impulsive symptom domains before the age of 12 years; Where it is not possible to gain sufficient clinical information to score childhood symptoms of ADHD, the operational criteria will be adapted to include evidence of several ADHD symptoms with impairment starting before the age of 12 years, and 5 or more symptoms currently with moderate to severe impairment 5. Persistent trait like (non-episodic) course of symptoms 6. Impairments in two or more clinical or psychosocial domains and two or more settings from symptoms of ADHD 7. Onset of symptoms before the age of 12 years Previous participant inclusion criteria: 1. Male, aged between 16 and 25 years 2. English speaking 3. Able to provide informed consent (understand the information sheet and make an informed decision taking into account pros and cons of study participation) 4. Meet clinical diagnostic criteria for DSM-5 ADHD: 5 or more current symptoms of ADHD in either the inattentive or hyperactive-impulsive symptom domains; 6 or more symptoms of ADHD in either the inattentive or hyperactiveimpulsive symptom domains before the age of 12 years; Where it is not possible to gain sufficient clinical information to score childhood symptoms of ADHD, the operational criteria will be adapted to include evidence of several ADHD symptoms with impairment starting before the age of 12 years, and 5 or more symptoms currently with moderate to severe impairment 5. Persistent trait like (non-episodic) course of symptoms 6. Impairments in two or more clinical or psychosocial domains and two or more settings from symptoms of ADHD 7. Onset of symptoms before the age of 12 years
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 22/01/2021: 1. Lack of capacity to give informed consent 2. Moderate or severe learning disability, defined as an IQ <60 3. Serious risk of violence to the researcher 4. Current major depression, psychosis, mania or hypomania 5. Past history of bipolar disorder or schizophrenia (such as those with a clear history of episodic mania/hypomania or psychosis unrelated to acute drug intoxication. Excluding chronic emotional dysregulation such as irritability, frustration, anger or emotional-mood instability) 6. Medical contraindications to the use of stimulants (e.g. glaucoma, hypertension, cardiovascular disease or structural heart problem) 7. Drug-seeking behaviour or craving (defined as drug-seeking behaviour that is unusually severe and likely to affect the titration protocol due to unusual and excessive demands for drugs; or where there is a current withdrawal syndrome from an addition disorder with drug dependency) 8. Taking contraindicated medication (e.g. Clonidine, Courmarins, Monoamine oxibase inhibitors, Moclobemide, Rasagline) during the four weeks prior to randomisation 9. Receiving any ADHD medication between consent for screening and randomisation Previous participant exclusion criteria: 1. Lack capacity to give informed consent 2. Moderate or severe learning disability, defined as IQ<60 3. Serious risk of violence to the researcher 4. Current major depression, psychosis, mania or hypomania 5. Past history of bipolar disorder or schizophrenia 6. Medical contraindications to the use of stimulants (e.g. glaucoma, hypertension, cardiovascular disease or structural heart problem) 7. Drug seeking behaviour or craving
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 22/01/2021: Level of ADHD symptoms measured on the investigator rated Connors Adult ADHD rating scale (CAARS-O) measured at baseline and after 8-weeks of treatment. Previous primary outcome measure: Level of ADHD symptoms measured on the investigator rated Connors Adult ADHD rating scale measured at baseline and after 8-weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 22/01/2021: 1. Emotional dysregulation rated by the investigator and measured using the Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) at baseline, 5, and 8 weeks 2. Critical incidents (adjudications) measured from prison records during the 8-week period before randomisation to the 8-week assessment 3. Aggressive behaviour rated by prison officer and education staff using the Modified Overt Aggression Scale (MOAS) at baseline and 8 weeks 4. Behaviour measured using behaviour report cards from prison staff (BRC-P) and education staff (BRC-E) at baseline and at week 8 5. Engagement in education, occupational, and rehabilitation programs measured from prison records during the 8-week period before randomisation to the 8-week assessment 6. Attitudes towards violence self-rated using the Maudsley Violence Questionnaire (MVQ) at baseline, week 5 and 8 7. Subjective well-being measured using the CORE Outcome Measure (CORE-M) at baseline and 8 weeks 8. Spontaneous mind wandering self-rated using the mind excessively wandering scale (MEWS) at baseline, 5, and 8 weeks 9. General psychopathology measured using the Brief Symptoms Inventory (BSI) at baseline, 5, and 8 weeks 10. Symptoms of irritability measured using the Affective Reactivity Index - Self Report (ARI-S) at baseline, 5, and 8 weeks 11. Overall health measured using Clinical Global Impression (CGI) at baseline, 5, and 8 weeks Previous secondary outcome measures: 1. Emotional dysregulation is rated by the investigator and measured on the Wender-Reimherr Adult ADHD Diagnostic Scale at baseline and 8 weeks 2. Number of negative Incentives and Earned Privileges (IEPs) and adjudications for antisocial behaviour and rule breaking reported in the prison records at baseline and 8 weeks 3. Aggressive behaviour is rated by prison officer and education staff using the Modified Overt Aggression Scale at baseline and 8 weeks 4. Number of positive incentive and ear | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed