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Clinical Trials/EUCTR2008-006242-26-DE
EUCTR2008-006242-26-DE
Active, not recruiting
Not Applicable

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

niversitätsklinikum Würzburg0 sitesAugust 7, 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
niversitätsklinikum Würzburg
Status
Active, not recruiting
Last Updated
13 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 7, 2009
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversitätsklinikum Würzburg

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Not specified

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