Ritalin and the developing brai

Phase 1

• Conditions: This project investigates whether the effects of methylfenidate on the outgrowth of the dopaminergic system are dependent on age. In a 16 week multicenter, dounle-blind, placebo controlled trial with methylfenidate in 100 children and adults suffering from ADHD, the effect of age is investigated using state of the art in vivo Magnetic Resonance Imaging (MRI) techniques that allow determination of the functional status of the dopaminergic system.; MedDRA version: 15.0Level: LLTClassification code 10064104Term: ADHDSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 15.0Level: LLTClassification code 10056941Term: MRI brainSystem Organ Class: 10022891 - Investigations; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2010-023654-37-NL
• Lead Sponsor: Academic Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-01
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

50 adolescent (10-12 years of age) and 50 adult (23-30 years of age) male outpatients diagnosed with type ADHD, all subtypes as defined in the DSM-IV, and in need of pharmacotherapy according to existing guidelines.
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Co-morbid Axis I psychiatric disorders requiring treatment with medication at study entry, and a history of epilepsy and traumatic brain injury.
-IQ < 70 (subtest Wechsler Intelligence Scale for children-Revised (WISC-R; Wechsler 1981) or National Adult Reading Test (NART; Nelson 1991, Dutch translation Schmand et al. 1991)
- Current or previous treatment with medications that influence the DA system (for adults before 23 years of age) such as: neuroleptics, antipsychotics, D2/D3 agonists (pramipexole and ropinirole)
-Current or previous (ab)use of drugs that influence the DA system (for adults before 23 years of age), such as: MDMA, amphetamine, methamphetamine, cocaine, heroine and LSD
-Contraindications to MPH treatment: cardiovascular diseases such as hypertension, arrhythmia, hyperthyroidism, glaucoma, suicidality, psychosis, Tourette disorder.
-Prenatal use of MPH by mother of the patients.
-Contraindications to MRI (metal implants, pacemakers, claustrophobia, etc.)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To report on the age-dependency of the effect(s) of MPH treatment on the outgrowth of the DA system using state-of-the-art Magnetic Resonance Imaging (MRI) techniques;Secondary Objective: 1. To report on the age-dependency of MPH on the outgrowth of the DA system using several functional outcome measures (functional MRI (fMRI), neuropsychological test battery)<br>2. To report on the effects of MPH on restless legs syndrome (RLS) symptoms and insomnia<br>;Primary end point(s): Primary study parameters/endpoints:<br>-phMRI: % change in ASL signal from baseline in response to acute oral MPH challenge before and after 16 weeks of MPH treatment<br>- DTI: % change in FA and MD values from baseline after 16 weeks of MPH treatment<br>-Resting state fMRI (rs-fMRI): % change in functional connectivity (FC) within specific (DA) neuronal networks<br>;Timepoint(s) of evaluation of this end point: In week 0 (baseline), week 8 and week 18

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -fMRI: % change in task related BOLD signal from baseline<br>-Neuropsychological functioning: change in outcome of several well-validated neuropsychological (computer) tasks addressing emotional processing and impulsivity/behavioral inhibition compared to baseline measurements.<br>-Sleep log and actigraph: % change from baseline<br>-DLMO: % change from baseline<br>;Timepoint(s) of evaluation of this end point: In week -1 (from baseline), week 0,week 7, week 8, week 17 and week 18