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

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00508677
First received: July 26, 2007
Last updated: September 30, 2009
Last verified: July 2007
History of Changes
  Purpose

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


Condition
Attention Deficit Hyperactivity Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Enrollment: 24
Study Start Date: March 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

childrens

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00508677

Locations
France
Hopital Robert Debre
Paris, France, 75019
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Eric KONOFAL, MD-PH Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Yannick VACHER, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00508677     History of Changes
Other Study ID Numbers: P060104
Study First Received: July 26, 2007
Last Updated: September 30, 2009
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Attention Deficit Hyperactivity Disorder
Mazindol

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mazindol
Central Nervous System Stimulants
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors
Dopamine Agents

ClinicalTrials.gov processed this record on May 19, 2013