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Completed

NCT Number: NCT01351272

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

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.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinic for Psychiatrie, Psychosomatics and Psychotherapy

Würzburg, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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

Treatment and study plan

Methylphenidate, non-retard

Drug

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.

Placebo

Drug

Primary outcomes

  1. 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.

Secondary outcomes

  1. Neuropsychology

    Time frame: 6 weeks

    Accuracy for the working memory paradigm at post. Accuracy was defined as the ratio of correct responses (correctly pressed and correctly not pressed) to total number of stimuli. Higher values indicate better perfromance.The theoretical range goes from 0 to 1.

  2. ADHD Core Symptoms: Measured by Conners Adult ADHD Rating Scales (CAARS), Inattention Scale

    Time frame: 6 weeks

    Changes in CAARS scale ( T-values, 50 indicates the population mean with a standard deviation of 10) from pre to post.

    Higher T values indicate higher symptoms. T-score over 60 indicates clinically relevant ADHS symptoms

    More negative values of the difference indicate higher symptom reduction, therefore a better outcome.

    Range of T-values for pre and post measurements between 35 and 90, potential range for differences -55 to +55

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Collaborators

  • German Research Foundation

Registry information

Official study title

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

Acronym: BEAS

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
May 10, 2011
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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