Antihistamines in the treatment of ADHD and allergy.
- Conditions
- attention-deficit/hyperactivitydisorder (ADHD), atopy, allergy, eczema, asthma, allergic rhinitis
- Registration Number
- NL-OMON24270
- Lead Sponsor
- Dr. T.W. de VriesMedical Center Leeuwarden PediatricsP.O. BOX 8888901 BR LeeuwardenTel. 058-2863385Fax. 058-2863390e-mail: tjalling.de.vries@znb.nl
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 70
Inclusion Criteria
The study will include children in whom the diagnosis of ADHD has established by a professional and who use methylphenidate and who have comorbid atopic diseases as atopic eczema, asthma, or allergic rhinitis.
Exclusion Criteria
A potential subject who meets any of the following criteria will be
excluded from participation in this study:
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Decrease of 5 points on the SNAP-IV as rated by the parent(s).<br /><br>Symptoms of asthma, eczema and rhinitis, which will be scored using the<br>Asthma Control Questionnaire (ACQ), a validated tool to assess asthma<br>control among children in clinical trials, the validated Three Item Skin Score (TISS) questionnaire, which is a practical and useful tool<br>for the intended eczema assessment, and the Total 4 Symptom Score<br>(T4SS).
- Secondary Outcome Measures
Name Time Method - Amount of sleep and sleeping problems, measured by a questionnaire on sleeping problems.<br /><br>- The score of ADHD in categories hyperactivity, inattention and impulsivity, as rated by the parents, measured by the SNAP IV Parent rating scale.<br /><br>- The score of ADHD total and in categories hyperactivity, inattention and impulsivity, as rated by the teacher, measured by the SNAP IV Teacher rating scale.<br /><br>- Frequency of adverse events of alimemazine and methylphenidate,<br>measured by a questionnaire on adverse events.