Mazindol in Children With ADHD : Open-label, Efficacy, Safety and Pharmacokinetic Pilot Trial
NCT ID: NCT00508677
Last Updated: 2009-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
24 participants
OBSERVATIONAL
2008-03-31
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Subjects must be aged between 6 to 12 years,
* Tanner 1 ou 2
* Subjects with a diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV) criteria
* ADHD-RS score of ≥ 31 as determined by investigator at screening visit.
* Drug free including psychostimulants (10 days before the screening visit)
* Informed Consent Form signed by the subject and both parents
* Healthy on the basis of a physical examination, medical history and the results of blood hematology tests.
Exclusion Criteria
* Sleep Disorders including narcolepsy, hypersomnia (according to International Classification of Sleep Disorders (ICSD) criteria
* Chronic diseases (e.g. asthma…)
* Current eating disorder (e.g. bulimia, anorexia nervosa) or history of an eating disorder during infancy
* Mental retardation (IQ \< 80)
* Hyperthyroidism
* Subjects with history of seizures, glaucoma or familial hypertension
* Heart pathologies
6 Years
12 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Department Clinical Research of Developpement
Principal Investigators
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Eric KONOFAL, MD-PH
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Hopital Robert Debre
Paris, , France
Countries
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Other Identifiers
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P060104
Identifier Type: -
Identifier Source: org_study_id
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