The effect of nortriptiline on nocturnal enuresis

Phase 2

• Conditions: Enuresis.; Nonorganic enuresis

• Registration Number: IRCT201111043930N16
• Lead Sponsor: Vice chancellor for research, Shiraz University of Medical Sciences

Brief Summary

BACKGROUND: <br /> <br /> Treating enuresis in children with attention deficit hyperactivity disorder (ADHD) has not been previously reported. This study aims to investigate the efficacy, tolerability, and adverse effects of nortriptyline for treating enuresis in children with ADHD.<br /> <br /> METHODS: <br /> <br /> Forty-three children aged from 5 to 14 years old were randomized into two groups. The treatment group received methylphenidate plus nortriptyline, while the placebo group received methylphenidate plus placebo. Nortriptyline and placebo were administered for 30 days and methylphenidate was administered for 45 days. The major outcome measure was parent-reported frequency of enuresis for 2 weeks prior to the intervention, during the intervention, and for 2 weeks after stopping the adjuvant therapy. Adverse effects were also checked.<br /> <br /> RESULTS: <br /> <br /> While nortriptyline statistically decreased the incidence of nocturnal enuresis during the intervention, the number of enuresis events did not significantly change in the placebo group. In addition, enuresis was not different from the baseline frequency of enuresis after stopping nortriptyline or placebo administration. Both nortriptyline and placebo were tolerated well.<br /> <br /> CONCLUSIONS: <br /> <br /> Administration of nortriptyline for treating enuresis in ADHD has not been investigated before. Nortriptyline is statistically superior to placebo. However, enuresis will relapse after stopping nortriptyline in children with ADHD who continue taking methylphenidate.<br />

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

meeting diagnostic criteria for current ADHD and primary enuresis according to DSM-IV-TR; aged 5 to 14 years; both genders; and providing written consent.
Exclusion criteria: any major psychosocial stressors; urinary complaints; and co-current behavior therapy for enuresis.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of enuresis. Timepoint: every 2 weeks. Method of measurement: parent report.