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

ADHD Clinical Trial

— BEAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01351272
• Other study ID #: W004PS0108_1
• Status: Completed
• Phase: Phase 3
• First received: April 29, 2011
• Last updated: December 9, 2014
• Start date: May 2011
• Est. completion date: March 2013

Study information

• Verified date: December 2014
• Source: Wuerzburg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity

Intervention

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.

Locations

Country	Name	City	State
Germany	Clinic for Psychiatrie, Psychosomatics and Psychotherapy	Würzburg

Sponsors (2)

Lead Sponsor	Collaborator
Wuerzburg University Hospital	German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks	No
Secondary	Neuropsychology	Correct answers and reaction time for the working memory paradigm Stroop task	6 weeks	No
Secondary	ADHD core symptoms: measured by ADHS Self Rating Scale (ASRS) score		6 weeks	No
Secondary	ADHD core symptoms: measured by Conners Adult ADHD Rating Scales (CAARS)		6 weeks	No
Secondary	ADHD core symptoms: measured by Clinical Global Impressions (CGI) Scale of ADHD Severity		6 weeks	No
Secondary	ADHD criteria measured by the Wender-Reimherr Interview (WRI)		6 weeks	No