- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01351272
Genetic Modulation of Working Memory in Attention Deficit Hyperactivity Disorder (ADHD) (BEAS)
December 9, 2014 updated by: Martin Herrmann, Wuerzburg University Hospital
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Würzburg, Germany
- Clinic for Psychiatrie, Psychosomatics and Psychotherapy
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: methylphenidate, non-retard
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brain activation
Time Frame: 6 weeks
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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.
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6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neuropsychology
Time Frame: 6 weeks
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Correct answers and reaction time for the working memory paradigm Stroop task
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6 weeks
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ADHD core symptoms: measured by ADHS Self Rating Scale (ASRS) score
Time Frame: 6 weeks
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6 weeks
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ADHD core symptoms: measured by Conners Adult ADHD Rating Scales (CAARS)
Time Frame: 6 weeks
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6 weeks
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ADHD core symptoms: measured by Clinical Global Impressions (CGI) Scale of ADHD Severity
Time Frame: 6 weeks
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6 weeks
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ADHD criteria measured by the Wender-Reimherr Interview (WRI)
Time Frame: 6 weeks
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6 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
April 29, 2011
First Submitted That Met QC Criteria
May 9, 2011
First Posted (Estimate)
May 10, 2011
Study Record Updates
Last Update Posted (Estimate)
December 10, 2014
Last Update Submitted That Met QC Criteria
December 9, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Attention Deficit and Disruptive Behavior Disorders
- Neurodevelopmental Disorders
- Attention Deficit Disorder with Hyperactivity
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Methylphenidate
Other Study ID Numbers
- W004PS0108_1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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