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
  Purpose

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.


Condition Intervention Phase
ADHD
Drug: Methylphenidate, non-retard
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Genetic Modulation of Functional Brain Activity of Attention-deficit/Hyperactivity Disorder-related Working Memory Processes

Resource links provided by NLM:


Further study details as provided by Wuerzburg University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: May 2011
Estimated Study Completion Date: March 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: methylphenidate, non-retard 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01351272

Locations
Germany
Clinic for Psychiatrie, Psychosomatics and Psychotherapy Recruiting
Würzburg, Germany
Contact: Jacob Christian, PD Dr. med.    +49 931 201 77811    jACOB_C@klinik.uni-wuerzburg.de   
Principal Investigator: Martin Herrmann, PD Dr         
Principal Investigator: Jürgen Deckert, Prof. Dr. med         
Sponsors and Collaborators
Wuerzburg University Hospital
German Research Foundation
  More Information

No publications provided

Responsible Party: Martin Herrmann, Principal Investigator, Wuerzburg University Hospital
ClinicalTrials.gov Identifier: NCT01351272     History of Changes
Other Study ID Numbers: W004PS0108_1
Study First Received: April 29, 2011
Last Updated: December 4, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014