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

Sponsor
Tanta University
Study ID
NCT06841666
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • ADHD
  • Primary Nocturnal Enuresis

Eligibility Criteria

Sex
ALL
Age
6 Years - 12 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Feb 24, 2025
Start date
Feb 28, 2025
Status verified
Feb 2025
Primary completion
Aug 30, 2025
Completion
Sep 5, 2025

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • 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.
  • 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.

Primary Outcome Measure

Frequency of nocturnal enuresis episodes, recorded by parents in a nightly log. [ Time Frame: 6months ]

Central Contacts

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