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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR3103 |
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Date of registration:
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13/10/2011 |
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Primary sponsor: |
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Public title:
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Effects of methylphenidate on the developing brain.
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Scientific title:
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Effect modification by age of methylphenidate on the development of the dopaminergic system in the brain. - ePOD - MPH |
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Date of first enrolment:
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1/5/2011 |
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Target sample size:
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100 |
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Recruitment status: |
recruiting |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3103 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Double; Control: Placebo; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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Liesbeth
Reneman |
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Address:
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Meibergdreef 9
1105 AZ
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 5668312 |
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Email:
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l.reneman@amc.uva.nl |
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Affiliation:
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Name:
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Liesbeth
Reneman |
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Address:
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Meibergdreef 9
1105 AZ
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 5668312 |
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Email:
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l.reneman@amc.uva.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Male outpatients (ages 10-12 and 23-30) newly diagnosed with ADHD as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV, American Psychiatric Association 1994) and as determined by a structured interview: Diagnostic Interview Schedule for Children fourth edition (DISC-IV; Ferdinand et al., 1998) in parents or Diagnostic Interview voor ADHD bij volwassenen (DIVA; Kooij andFrancken, 2010) in adults.
Exclusion criteria: 1. Co-morbid Axis I psychiatric disorders requiring treatment with medication at study entry;
2. Major medical illness, such as a history of epilepsy and traumatic brain injury;
3. IQ < 80;
4. Current or previous (including prenatal) dependency of drugs or medications that influence the dopamine system before age 23
5. Any contraindications to methylfenidate treatment or MRI proceedings.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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ADHD, Methylphenidat, Dopaminergic system
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Intervention(s)
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1. Random assignment to a flexible dose of methylphenidate or placebo drug treatment for 16 weeks, followed by a medication-free wash-out period of one week;
2. 3.0 Tesla MR imaging including diffusion tensor imaging (DTI), task-related functional MRI (fMRI) and pharmacological MRI (phMRI) following dopaminergic challenge with oral methylphenidate (0.5 mg/kg);
3. Assessment of a neuropsychological test battery and short questionnaires;
4. Assessment of sleep with actigraphy.
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Primary Outcome(s)
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1. phMRI: % change in ASL signal from baseline in response to acute oral MPH challenge before and after 16 weeks of MPH treatment;
2. DTI: % change in FA and MD values from baseline after 16 weeks of MPH treatment;
3. Resting state fMRI (rs-fMRI): % change in functional connectivity (FC) within specific (DA) neuronal networks;
4. % change of above mentioned outcome parameters during treatment vs. baseline and post-treatment.
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Secondary Outcome(s)
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1. fMRI: % change in task related BOLD signal from baseline;
2. Neuropsychological functioning: change in outcome of several well-validated neuropsychological (computer) tasks addressing emotional processing and impulsivity/behavioral inhibition compared to baseline measurements;
3. Sleep log and actigraphy: % change from baseline.
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Secondary ID(s)
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NL34509.000.10
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Source(s) of Monetary Support
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Ministry of Education, Culture and Science
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