Genetic Modulation of Working Memory in Attention Deficit Hyperactivity Disorder (ADHD) (BEAS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Wuerzburg University Hospital
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Martin Herrmann, Wuerzburg University Hospital
ClinicalTrials.gov Identifier:
NCT01351272
First received: April 29, 2011
Last updated: December 4, 2012
Last verified: December 2012

April 29, 2011
December 4, 2012
May 2011
December 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01351272 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Neuropsychology [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Correct answers and reaction time for the working memory paradigm Stroop task
  • Questionaires [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    ADHS Self Rating Scale (ASRS) score CAARS Wender - Reimherr - Interview Clinical Global Impression Scale
Not Provided
Not Provided
 
Genetic Modulation of Working Memory in Attention Deficit Hyperactivity Disorder (ADHD)
Genetic Modulation of Functional Brain Activity of Attention-deficit/Hyperactivity Disorder-related Working Memory Processes

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
ADHD
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.
Experimental: methylphenidate, non-retard
Intervention: Drug: Methylphenidate, non-retard
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
March 2013
December 2012   (final data collection date for primary outcome measure)

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, vasoligature 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, hyperthyreoidism, thyreotoxicosis, cardiac arrhythmia, cardiac infarction) as judged by the investigator.
  • Epilepsy
  • An absolute neutrophil count (ANC) of minor 1.5 x 10 exp 9 per litre
  • Involvement in the planning and conduct of the study
  • Previous enrolment or randomisation of treatment in the present study
  • Participation in another drug trial within 4 weeks prior to enrolment into this study
  • Moderate, severe, or profound mental retardation
  • Heart pacemakers, cochlea implants, other metal parts in the head outside the mouth
Both
18 Years to 50 Years
No
Germany
 
NCT01351272
W004PS0108_1
Yes
Martin Herrmann, Wuerzburg University Hospital
Wuerzburg University Hospital
German Research Foundation
Not Provided
Wuerzburg University Hospital
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP