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

NCT06841666 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 36264؛ٌ1054/1/25
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.Primary Aim: To evaluate the efficacy of atomoxetine in reducing the frequency of primary nocturnal enuresis episodes in children with ADHD.
2. 2.Secondary Aim: To determine if improvements in attention symptoms correlate with reductions in nocturnal enuresis episodes.

Conditions

ADHD; Primary Nocturnal Enuresis

Keywords

Primary Nocturnal Enuresis; ADHD; Atomoxetine

Outcome Measures

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.

  6months

Secondary Outcomes (1)

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

  6months

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

Atomoxetine DRUG

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

Group 1 (Treatment)

Placebo DRUG

Placebo identical in form and dosing schedule for six months.

Group 2 (Control)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Related Publications (1)

• 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.

  PMID: 24761279 RESULT

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Central Study Contacts

Osama Ibrahim Younes

CONTACT

01024188789; osamaebrahim2012@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of psychiatry

Model Details: A Randomized, Placebo-Controlled Study

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 24, 2025
• Study Start: February 28, 2025
• Primary Completion: August 30, 2025
• Study Completion: September 5, 2025
• Last Updated: February 27, 2025

Record last verified: 2025-02