Genetic modulation of functional brain activity of attention-deficit/hyperactivity disorder-related working memory processes

• Conditions: Attention-deficit hyperactivity disorder (ADHD); MedDRA version: 9.1Level: LLTClassification code 10064104Term: ADHD

• Registration Number: EUCTR2008-006242-26-DE
• Lead Sponsor: niversitätsklinikum Würzburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-07
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.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.
2.Provision of written informed consent
3.A diagnosis of a ADHD (314.xx) by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
4.Females and males aged 18-50 years
5.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
6.Able to understand and comply with the requirements of the study
7.Right-handed according Edinburgh Handedness Inventory (Oldfield, 1971)
8.German as first language
9.Caucasian ethnicity

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.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, vasoligature in the partner, sexual abstinent)
2.Any current DSM-IV Axis I disorder not defined in the inclusion criteria requiring current additional treatment
3.Motoric tics, siblings with tics or positive family history or diagnosis of a Tourette syndrome
4.Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
5.Known intolerance or lack of response to methylphenidate, as judged by the investigator
6.Present pre-treatment with methylphenidate within the last 3 month prior to study treatment
7.Intake of MAO-inhibitors within the last 14 days prior to of study treatment
8.Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
9.Unstable or inadequately treated medical illness (e.g. Congestive Heart Failure / CHF, angina pectoris, hypertension, narrow angle glaucoma, hyperthyreoidism, thyreotoxicosis, cardiac arrhythmia, cardiac infarction) as judged by the investigator.
10.Epilepsy
11.An absolute neutrophil count (ANC) of ?1.5 x 109 per litre
12.Involvement in the planning and conduct of the study
13.Previous enrolment or randomisation of treatment in the present study
14.Participation in another drug trial within 4 weeks prior to enrolment into this study or longer in accordance with local requirements
15.Moderate, severe, or profound mental retardation
16.Heart pacemakers, cochlea implants, other metal parts in the head outside the mouth

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To examine the modulation of the functional brain activity during working memory processes by therapeutic methylphenidate administration in ADHD patients, in interaction with the COMT Val158Met genotype.;Secondary Objective: To examine the clinical improvement of ADHD symptoms and general functioning by therapeutic methylphenidate administration in ADHD patients, in interaction with the COMT Val158Met genotype.;Primary end point(s): fMRI measurement at day 42