Evaluating the Efficacy of Atomoxetine in Reducing Primary Nocturnal Enuresis in Children With ADHD: A Randomized, Placebo-Controlled Study

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age6-12
SponsorTanta University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Atomoxetine

    Drug

    Atomoxetine, 0.5-1.2 mg/kg/day, administered in the evening for six months.

  • Placebo

    Drug

    Placebo identical in form and dosing schedule for six months.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Group 1 (Treatment)Experimental treatment 1 intervention
Group B: Group 2 (Control)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
6months

Secondary outcomes

1

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.

Time frame
6months

Other outcomes

Locations

This trial has no 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: