Genetic Modulation of Working Memory in Attention Deficit Hyperactivity Disorder (ADHD) (BEAS)
In this study the investigators will measure the functional brain activity of adult Attention Deficit Hyperactivity Disorder (ADHD) patients, genotyped according to the COMT genotype, during a Working Memory Paradigm, before and after a placebo controlled treatment with MPH for 6 WEEKS. Within this design, the investigators will be able to evaluate the therapeutic effect of MPH treatment on cognitive functions.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
|Official Title:||Genetic Modulation of Functional Brain Activity of Attention-deficit/Hyperactivity Disorder-related Working Memory Processes|
- Brain activation [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Functional brain activity during the working memory task as measured by fMRI. For each participant and conditions the estimated parameters are metric, and can be further analysed with ANOVAs or t-tests.
- Neuropsychology [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Correct answers and reaction time for the working memory paradigm Stroop task
- ADHD core symptoms: measured by ADHS Self Rating Scale (ASRS) score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- ADHD core symptoms: measured by Conners Adult ADHD Rating Scales (CAARS) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- ADHD core symptoms: measured by Clinical Global Impressions (CGI) Scale of ADHD Severity [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- ADHD criteria measured by the Wender-Reimherr Interview (WRI) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||May 2011|
|Study Completion Date:||March 2013|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
|Experimental: methylphenidate, non-retard||
Drug: Methylphenidate, non-retard
Medication (methylphenidate, non-retard) will be titrated to optimal response within 6 weeks, with a maximum of 10 mg/day in week 1, 20 mg/day in week 2, 30 mg/day in week 3, 40 mg/day in week 4, 50 mg/day in week 5, and 60 mg/day in week 6, unless adverse effects emerged. After successful adjustment, medication will be maintained until week 6. Dosing will be based on at least two-weekly evaluations by a psychiatrist, including an interview with a review of symptoms and side effects, completion of the Clinical Global Impression (CGI) scale and completion of a standardised Side Effects Rating Scale for psychostimulants (SERS). The maximal daily dosage of MPH is 60 mg. Within this double blind study the same procedure is applied for the placebo condition.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01351272
|Clinic for Psychiatrie, Psychosomatics and Psychotherapy|