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NCT Number: NCT06841666

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

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.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

About this study

Attention-Deficit/Hyperactivity Disorder (ADHD) is a prevalent neurodevelopmental disorder affecting approximately 5-7% of school-aged children globally. It is characterized by inattention, hyperactivity, and impulsivity, impairing academic, social, and daily functioning (American Psychiatric Association, 2013). The Conners-48 scale is frequently used to assess ADHD severity, offering a standardized tool for research and clinical practice. Treatments for ADHD often combine behavioral therapies with pharmacological agents such as stimulants or non-stimulants, including atomoxetine (Cortese et al., 2016).

Primary nocturnal enuresis (PNE) refers to involuntary urination during sleep in children aged five or older, without any underlying organic or neurological disorder. While PNE typically diminishes with age, its persistence can cause significant psychosocial stress for children and their families. Studies suggest that children with ADHD experience PNE at higher rates than their neurotypical peers, underscoring the need for tailored management strategies (Hagerty et al., 2015).

Interrelationship Between ADHD and Enuresis:

Shared neurobiological pathways may explain the coexistence of ADHD and PNE. Both conditions involve dysregulation in arousal and inhibitory control mechanisms, leading to disrupted sleep patterns and impaired bladder control during sleep (Shreeram et al., 2009). Despite this overlap, current treatment paradigms rarely address both conditions concurrently, leaving a clinical gap in care.

Rationale for Atomoxetine in PNE:

Atomoxetine, a selective norepinephrine reuptake inhibitor, is a non-stimulant ADHD medication effective for managing attention deficits and impulsivity. It may also influence bladder control by enhancing norepinephrine activity in brainstem regions implicated in micturition (Kim et al., 2015). This potential dual benefit positions atomoxetine as a promising treatment option for ADHD and comorbid PNE.

Clinical and Research Gap:

Although extensive research has validated atomoxetine's efficacy for ADHD, limited studies explore its effects on comorbid conditions like PNE. This study aims to evaluate the frequency of nocturnal enuresis episodes and changes in ADHD symptoms, providing insight into atomoxetine's potential dual benefits. Findings may inform integrated therapeutic approaches for children with ADHD and PNE.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged 6-12 years diagnosed with ADHD per Conners-48 scale. Children experiencing primary nocturnal enuresis.

Exclusion criteria

  • Secondary causes of enuresis (e.g., urinary tract infections, diabetes). Use of other enuresis treatments. Known contraindications to atomoxetine.

Treatment and study plan

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.

Primary outcomes

  1. Frequency of nocturnal enuresis episodes, recorded by parents in a nightly log.

    Time frame: 6months

    • Baseline data: enuresis frequency.
    • Follow-up assessments at 1, 3, and 6 months:

    Parent-maintained logs of enuresis episodes.

Secondary outcomes

  1. ADHD symptoms, assessed using Conners-48 scores at baseline, 1, 3, and 6 months

    Time frame: 6months

    • 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Osama Ibrahim Younes

CONTACT

[email protected]

01024188789

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Evaluating the Efficacy of Atomoxetine in Reducing Primary Nocturnal Enuresis in Children With ADHD

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 24, 2025
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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