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

NCT ID: NCT01351272

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2013-03-31

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.

Conditions

ADHD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

methylphenidate, non-retard

Group Type: EXPERIMENTAL

Methylphenidate, non-retard

Intervention Type: 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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

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.

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

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

• 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

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Research Foundation

OTHER

Sponsor Role: collaborator

Wuerzburg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Martin Herrmann

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Clinic for Psychiatrie, Psychosomatics and Psychotherapy

Würzburg, , Germany

Countries

Germany

Other Identifiers

W004PS0108_1

Identifier Type: -

Identifier Source: org_study_id