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

NCT01351272 | Completed Phase 3 Results DMC

• 1 other identifier: W004PS0108_1
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Brain Activation

  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.

  6 weeks

Secondary Outcomes (2)

• Neuropsychology

  6 weeks

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

  6 weeks

Study Arms (2)

methylphenidate, non-retard

EXPERIMENTAL

Drug: Methylphenidate, non-retard

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

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.

methylphenidate, non-retard

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Wuerzburg University Hospital: lead
• German Research Foundation: collaborator

Study Sites (1)

Clinic for Psychiatrie, Psychosomatics and Psychotherapy

Würzburg, Germany

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Prof. Dr. M. Herrmann
• Organization: Universitätsklinikum Würzburg

Herrmann_m@ukw.de

093120176650

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 29, 2011
• First Posted: May 10, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: August 15, 2024
• Results First Posted: August 15, 2024

Record last verified: 2024-03

Locations

DE (1)