Mazindol in Children With ADHD : Open-label, Efficacy, Safety and Pharmacokinetic Pilot Trial

This prospective pilot trial will evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) and pharmacodynamic (PD) properties of mazindol.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Robert Debre

Paris, 75019, France

About this study

The most common intervention for Attention Deficit Hyperactivity Disorder (ADHD) is pharmacological treatment with methylphenidate (MPH). Effects of MPH on ADHD symptoms in children is extremely well-informed. Mazindol is a psychostimulant and a wake-promoter agent which may have similar actions to MPH in the central nervous system. However, there is no record of the effects, safety, tolerability of Mazindol in children with ADHD. Mazindol (dose 0.5 or 1.0 mg/day) should prove to be useful in the treatment of ADHD symptoms in children. Based on clinical assessments and serum concentrations after oral administration of mazindol to children (6-12 years) with ADHD, this prospective pilot trial will evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) and pharmacodynamic (PD) properties of mazindol.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects can be boys or girls
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

Any clinically unstable psychiatric condition including, but not limited to the following: acute mood disorder, bipolar disorder, obsessive-compulsive disorder (OCD), autism or Asperger…
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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Mazindol in Children With Attention Deficit Hyperactivity Disorder Design Study to Explore the Effectiveness, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Two Orally Administered Doses of Mazindol.

Acronym: MAZDAH

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Jul 30, 2007
Registry last updated: Oct 1, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed