ADHD
Conditions
Interventions
1 week lead-in OROS-Mph (36 mg)
1 week OROS-Mph (72 mg)
1 week wash-out
1 week lead-in placebo (36 mg)
1 week placebo (72 mg)
or vice versa (related to cross over design)
Sponsors
Parnassia (Den Haag)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: ADHD-combined subtype has been diagnosed according to regular clinical diagnostic procedures Age 18-55 Patient is able to read and understand Patient Information Patient has signed Informed Consent Form Patient is able and willing to fill out questionnaires Patient is able and willing to meet follow up appointments for the study
Exclusion criteria
Exclusion criteria: - Comorbid disorder (Axis I) that is very severe at intake and that may interfere with need of rapid treatment or with the goals of the study: Psychosis Severe current substance abuse or substance dependence (alcohol: more than 2 consumptions per day or for women more than 15 consumptions in total per week or for men more than 21 conusmptions in total per week. Cannabis: more than one joint per day. Hard drugs: exclusion per se);Anxiety and/or mood disorders will be treated with SSRIs before treatment for ADHD starts.;- Use of the following medications within a month prior to participation to the study: stimulants, anti-psychotic medication, clonidine, benzodiazepines, beta-blockers;- Symptoms of dementia, amnestic disorders or other cognitive disorders;- Symptoms of serious Cluster B Axis II psychopathology that may interfere with cooperation to the study;- For women: pregnancy, breastfeeding of lack of suitable contraception;- Mental retardation;- Insufficient fluency in the Dutch language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response to medication: • ADHD Rating Scale (self report) • Clinical Global Impression (CGI-Improvement; investigator based) Clinical response is defined as: decrease of at least 2 points on the CGI and a decrease in complaints on the ADHD Rating Scale of at least 30 % CPTs For both CPTs the following dependent variables will be compared: 1. Omission errors Missed goal stimuli, a measure of sustained attention/ vigilance 2. Commission errors Reponse to non-goal stimulus: a measure for impulsivity/ inhibition 3. Mean hit reaction time Measure of the latency of the response execution proces 4. Standard deviation of mean hit reaction time Measure for consistency of responses 5. *attentiveness* (d*) Derived from signal detection theory: a measure for distinction between goal and non-goal stimuli 6. *risk taking* (β) Derived from signal detection theory: measure of response style (cautious version impulsive) | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicable. | — |
Countries
Netherlands
Outcome results
None listed