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

February 25, 2025 updated by: Osama Ibrahim Younes, Tanta University

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

  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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1 (Treatment)

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

Frequency of nocturnal enuresis episodes, recorded by parents in a nightly log. ADHD symptoms, assessed using Conners-48 scores at baseline, 1, 3, and 6 months.
Drug: Atomoxetine
Atomoxetine, 0.5-1.2 mg/kg/day, administered in the evening for six months.
Experimental: Group 2 (Control)

50 participants will receive Placebo identical in form and dosing schedule. for 6 months.

Frequency of nocturnal enuresis episodes, recorded by parents in a nightly log. ADHD symptoms, assessed using Conners-48 scores at baseline, 1, 3, and 6 months.
Drug: Placebo
Placebo identical in form and dosing schedule for six months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 28, 2025

Primary Completion (Estimated)

August 30, 2025

Study Completion (Estimated)

September 5, 2025

Study Registration Dates

First Submitted

February 18, 2025

First Submitted That Met QC Criteria

February 18, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36264؛ٌ1054/1/25

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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