Antihistamines in the treatment of ADHD and allergy.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24270

Enrollment

Registered

2014-11-03

Start date

2015-01-06

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

attention-deficit/hyperactivity disorder (ADHD), atopy, allergy, eczema, asthma, allergic rhinitis

Interventions

The study is designed as a randomized cross-over study. Participants aged 6-12 years are using methylphenidate and will be asked to continue their treatment as prescribed by their physician throughout

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Decrease of 5 points on the SNAP-IV as rated by the parent(s). Symptoms of asthma, eczema and rhinitis, which will be scored using the Asthma Control Questionnaire (ACQ), a validated tool to assess asthma control among children in clinical trials, the validated Three Item Skin Score (TISS) questionnaire, which is a practical and useful tool for the intended eczema assessment, and the Total 4 Symptom Score (T4SS).	—

Measure

Time frame

Decrease of 5 points on the SNAP-IV as rated by the parent(s). Symptoms of asthma, eczema and rhinitis, which will be scored using the Asthma Control Questionnaire (ACQ), a validated tool to assess asthma control among children in clinical trials, the validated Three Item Skin Score (TISS) questionnaire, which is a practical and useful tool for the intended eczema assessment, and the Total 4 Symptom Score (T4SS).

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Secondary

Measure	Time frame
- Amount of sleep and sleeping problems, measured by a questionnaire on sleeping problems. - The score of ADHD in categories hyperactivity, inattention and impulsivity, as rated by the parents, measured by the SNAP IV Parent rating scale. - 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. - Frequency of adverse events of alimemazine and methylphenidate, measured by a questionnaire on adverse events.	—

Measure

Time frame

- Amount of sleep and sleeping problems, measured by a questionnaire on sleeping problems. - The score of ADHD in categories hyperactivity, inattention and impulsivity, as rated by the parents, measured by the SNAP IV Parent rating scale. - 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. - Frequency of adverse events of alimemazine and methylphenidate, measured by a questionnaire on adverse events.

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Contacts

Public ContactJ. Schans, van der

Rijksuniversiteit Groningen

j.van.der.schans@rug.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)