Systemic antihistamines in the treatment of attention-deficit/hyperactivity disorder (ADHD): a pilot study.

Phase 4

Withdrawn

Conditions: ADHD
attention deficit and hyperactivity disorder
allergy
10001708
10009841

Registration Number: NL-OMON42065

Lead Sponsor: Medisch Centrum Leeuwarden

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 60

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:
- Being diagnosed with any chronic disease other than ADHD, including diabetes and epilepsy.
- Being treated with other medications on a daily base. Interval treatment with painkillers, bronchodilators, ointments, drops etc. are allowed.
- Unable to fulfill study procedures
- Not fluent in Dutch language
- Sufficiently treated and no improvement expected, as judged by the parents.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary determinant is the score of symptoms of the allergic disease and of<br /><br>ADHD, measured by the SNAP IV Teacher and Parent rating scale, as filled in by<br /><br>parents</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The score of ADHD symptoms, as rated by the school teachers using the SNAP IV<br /><br>Teacher and Parent rating scale. Frequency of side effects of alimemazine and<br /><br>methylphenidate, measured by a questionnaire on side effects, amount of sleep<br /><br>and sleeping problems.</p><br>