Clinical trial NCT06841666: Evaluating the Efficacy of Atomoxetine in Reducing Primary Nocturnal Enuresis in Children With ADHD: A Randomized, Placebo-Controlled Study
Official title: Evaluating the Efficacy of Atomoxetine in Reducing Primary Nocturnal Enuresis in Children With ADHD
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: ADHD
Primary Nocturnal Enuresis
Keywords: Primary Nocturnal Enuresis
ADHD
Atomoxetine
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized, Placebo-Controlled Study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Frequency of nocturnal enuresis episodes, recorded by parents in a nightly log.
timeFrame: 6months
Secondary outcomes:
measure: ADHD symptoms, assessed using Conners-48 scores at baseline, 1, 3, and 6 months
timeFrame: 6months
Other outcomes:
Locations:
Study officials:
References:
citation: Meredith SE, Juliano LM, Hughes JR, Griffiths RR. Caffeine Use Disorder: A Comprehensive Review and Research Agenda. J Caffeine Res. 2013 Sep;3(3):114-130. doi: 10.1089/jcr.2013.0016.