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

Primary Purpose

ADHD

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Methylphenidate, non-retard
Sponsored by
Wuerzburg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for ADHD

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinic for Psychiatrie, Psychosomatics and Psychotherapy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

methylphenidate, non-retard

Arm Description

Outcomes

Primary Outcome Measures

Brain activation
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
Correct answers and reaction time for the working memory paradigm Stroop task
ADHD core symptoms: measured by ADHS Self Rating Scale (ASRS) score
ADHD core symptoms: measured by Conners Adult ADHD Rating Scales (CAARS)
ADHD core symptoms: measured by Clinical Global Impressions (CGI) Scale of ADHD Severity
ADHD criteria measured by the Wender-Reimherr Interview (WRI)

Full Information

First Posted
April 29, 2011
Last Updated
December 9, 2014
Sponsor
Wuerzburg University Hospital
Collaborators
German Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01351272
Brief Title
Genetic Modulation of Working Memory in Attention Deficit Hyperactivity Disorder (ADHD)
Acronym
BEAS
Official Title
Genetic Modulation of Functional Brain Activity of Attention-deficit/Hyperactivity Disorder-related Working Memory Processes
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wuerzburg University Hospital
Collaborators
German Research Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
methylphenidate, non-retard
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Methylphenidate, non-retard
Intervention Description
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.
Primary Outcome Measure Information:
Title
Brain activation
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Neuropsychology
Description
Correct answers and reaction time for the working memory paradigm Stroop task
Time Frame
6 weeks
Title
ADHD core symptoms: measured by ADHS Self Rating Scale (ASRS) score
Time Frame
6 weeks
Title
ADHD core symptoms: measured by Conners Adult ADHD Rating Scales (CAARS)
Time Frame
6 weeks
Title
ADHD core symptoms: measured by Clinical Global Impressions (CGI) Scale of ADHD Severity
Time Frame
6 weeks
Title
ADHD criteria measured by the Wender-Reimherr Interview (WRI)
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Clinic for Psychiatrie, Psychosomatics and Psychotherapy
City
Würzburg
Country
Germany

12. IPD Sharing Statement

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

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