About this trial
1. Primary Aim: To evaluate the efficacy of atomoxetine in reducing the frequency of primary nocturnal enuresis episodes in children with ADHD. 2. Secondary Aim: To determine if improvements in attention symptoms correlate with reductions in nocturnal enuresis episodes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Children aged 6-12 years diagnosed with ADHD per Conners-48 scale. Children experiencing primary nocturnal enuresis.
Disqualifiers
Secondary causes of enuresis (e.g., urinary tract infections, diabetes). Use of other enuresis treatments. Known contraindications to atomoxetine.
Trial design
Parallel
Treatments tested in this trial
Atomoxetine
DrugAtomoxetine, 0.5-1.2 mg/kg/day, administered in the evening for six months.
Placebo
DrugPlacebo identical in form and dosing schedule for six months.
Treatment groups
Trial outcomes
Primary outcomes
Frequency of nocturnal enuresis episodes, recorded by parents in a nightly log.
* Baseline data: enuresis frequency. * Follow-up assessments at 1, 3, and 6 months: Parent-maintained logs of enuresis episodes.
Secondary outcomes
ADHD symptoms, assessed using Conners-48 scores at baseline, 1, 3, and 6 months
* Baseline data: demographic details, ADHD severity (Conners-48), * Follow-up assessments at 1, 3, and 6 months: * Conners-48 scores to monitor ADHD symptom changes.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: