Genetic Modulation of Functional Brain Activity of Attention-deficit/Hyperactivity Disorder-related Working Memory Processes

Wuerzburg University Hospital1 site in 1 country41 target enrollmentMay 2011

ConditionsADHD

InterventionsMethylphenidate, non-retard Placebo

DrugsMethylphenidate, non-retard Placebo

Overview

Phase: Phase 3
Intervention: Methylphenidate, non-retard
Conditions: ADHD
Sponsor: Wuerzburg University Hospital
Enrollment: 41
Locations: 1
Primary Endpoint: Brain Activation
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 2011

End Date

March 2013

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Wuerzburg University Hospital

Responsible Party

Principal Investigator

Martin Herrmann

Principal Investigator

Wuerzburg University Hospital

Eligibility Criteria

Inclusion Criteria

•Only participants will be included who (1) fulfil the diagnostic criteria defined in guidelines for the diagnosis of ADHD in childhood and adulthood and who (2) would be treated with MPH also for clinical indications outside the study.
•Provision of written informed consent
•A diagnosis of a ADHD (314.xx) by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
•Females and males aged 18-50 years
•Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment
•Able to understand and comply with the requirements of the study
•Right-handed according Edinburgh Handedness Inventory (Oldfield, 1971)
•German as first language
•Caucasian ethnicity

Exclusion Criteria

•Pregnancy or lactation; women capable of childbearing are required to use a reliable method (Pearl-index \< 1%) of contraception (e.g. hormonal treatment, intrauterine device, vasoligation in the partner, sexual abstinent)
•Any current DSM-IV Axis I disorder not defined in the inclusion criteria requiring current additional treatment
•Motoric tics, siblings with tics or positive family history or diagnosis of a Tourette syndrome
•Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
•Known intolerance or lack of response to methylphenidate, as judged by the investigator
•Present pre-treatment with methylphenidate (within the last three month prior to study treatment)
•Intake of MAO-inhibitors within the last 14 days prior to study treatment
•Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
•Unstable or inadequately treated medical illness (e.g. Congestive Heart Failure / CHF, angina pectoris, hypertension, narrow angle glaucoma, hyperthyroidism, thyreotoxicosis, cardiac arrhythmia, cardiac infarction) as judged by the investigator.
•An absolute neutrophil count (ANC) of minor 1.5 x 10 exp 9 per litre

Arms & Interventions

methylphenidate, non-retard

Intervention: Methylphenidate, non-retard

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Brain Activation

Time Frame: 6 weeks

Functional brain activity in right Superior Frontal Gyrus (SFG) during the working memory task post treatment as measured by fMRI. For each participant and conditions the estimated parameters are metric, and can be further analysed with ANOVAs or t-tests.