The main objective of the study is to find an instrument that can be used to objectively establish improvement in adults with ADHD with treatment with OROS-Mph, so that adherence to treatment can be increased and so that patients and docters can…
ID
Source
Brief title
Condition
- Psychiatric disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Not applicable.
Background summary
Attention Deficit Hyperactivity Disorder (ADHD) is a disorder that leads to
serious symptoms and impairment in children as well as adults. Treatment of
choice is methylphenidate. Until recently, only a short acting version of this
drug was available, but a long acting version that only has to be taken once a
day is now available (OROS-methylphenidate; OROS-MPh). This leads to better
treatment adherence, but still adults with ADHD show problems with adherence to
their medication because it is hard for them to evaluate their own improvements
due to their attention deficit. This causes large clinical needs for an
objective measurement of improvement with medication. A suitable candidate for
this may be found in the Continuous Performance Test (CPT), a computerized test
for attanion and inhibition. Several versions of this test are now commercially
available, two of which will be compared in this study.
Study objective
The main objective of the study is to find an instrument that can be used to
objectively establish improvement in adults with ADHD with treatment with
OROS-Mph, so that adherence to treatment can be increased and so that patients
and docters can objectively see improvement when there is doubt about the
effects of treatment. Further goals are connecting clinical response and
response on the CPT with OROS-Mph to certain genetic polymorphisms that have
been associated with ADHD.
Study design
Double blind cross-over placebo controled random trial.
Intervention
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)
Study burden and risks
Risks are minimal.
The burden for participants is six visits to the clinic. Each visit has a mean
duration of half an hour.
Carel Reinierszkade 197
2593 HR Den Haag
NL
Carel Reinierszkade 197
2593 HR Den Haag
NL
Listed location countries
Age
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
- 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-001294-28-NL |
| CCMO | NL16911.097.07 |