ADHDEarly Phase 1NCT06841666
Evaluating the Efficacy of Atomoxetine in Reducing Primary Nocturnal Enuresis in Children With ADHD: A Randomized, Placebo-Controlled Study
A Early Phase 1 study testing Atomoxetine in people with ADHD and Primary Nocturnal Enuresis, run by Tanta University.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD, Primary Nocturnal Enuresis
- What is being tested?
- Atomoxetine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2025to 5 Sep 2025
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6-12 years diagnosed with ADHD per Conners-48 scale. Children experiencing primary nocturnal enuresis.
Who cannot join
- Secondary causes of enuresis (e.g., urinary tract infections, diabetes). Use of other enuresis treatments. Known contraindications to atomoxetine.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluating the Efficacy of Atomoxetine in Reducing Primary Nocturnal Enuresis in Children With ADHD
- Primary Aim: To evaluate the efficacy of atomoxetine in reducing the frequency of primary nocturnal enuresis episodes in children with ADHD.
- Secondary Aim: To determine if improvements in attention symptoms correlate with reductions in nocturnal enuresis episodes.
Read the 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.
- Conditions
- ADHD, Primary Nocturnal Enuresis
- Being tested
- Atomoxetine, Placebo
- Keywords
- Primary Nocturnal Enuresis, ADHD, Atomoxetine
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtomoxetineDrug
Atomoxetine, 0.5-1.2 mg/kg/day, administered in the evening for six months.
PlaceboDrug
Placebo identical in form and dosing schedule for six months.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Treatment) | Experimental | 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. Receives: Drug: Atomoxetine |
| Group 2 (Control) | Experimental | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start28 Feb 2025 (estimated)
- Primary completion30 Aug 2025 (estimated)
- Study completion5 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized, Placebo-Controlled Study
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Ibrahim Younes, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841666
- Sponsor's protocol ID
- 36264؛ٌ1054/1/25
- Status last verified
- Feb 2025
- First submitted
- 18 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24761279