NCT00962039

Anxiety and Recurrent Abdominal Pain in Children

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: John V. Campo, M.D. · Academic / Other
• Sex: All
• Age: 7 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to determine whether citalopram is a useful, well-tolerated, and safe treatment for children and adolescents ages 7 to 18 years with functional abdominal pain. The study hypothesis is that citalopram will be better than placebo in producing clinical improvement and reductions in abdominal pain. It is also hypothesized that citalopram and placebo will not differ in terms of safety and tolerability.

Detailed description

This study aims to determine the relative efficacy, tolerability, and safety of the citalopram in the treatment of pediatric functional recurrent abdominal pain (FAP) in children and adolescents ages 7 to 18 years, inclusive. The goal is to recruit and randomize 100 subjects to citalopram or placebo. Secondary aims include to determine if citalopram is superior to placebo in reducing comorbid anxiety and depressive symptoms in children and adolescents with FAP, to explore potential mediators (i.e., anxiety, depression) and moderators (e.g., age, gender, referral from primary or specialty care) of treatment response, and to explore the durability and tolerability of citalopram treatment 18 weeks following completion of the double-blind treatment phase with the goal of generating data useful to the development of future studies. The study is novel in conducting recruitment, assessment, and treatment in traditional medical settings. Limited exclusion criteria and the delivery of study assessments and interventions within routine practice settings provide for considerably greater external validity than the typical efficacy study. Study hypotheses: 1. Citalopram will be superior to placebo in producing clinical improvement and reductions in abdominal pain. 2. Citalopram and placebo will not differ in tolerability or safety.

Conditions

• Abdominal Pain
• Anxiety

Interventions

Type	Name	Description
DRUG	Citalopram	Participants will be randomly assigned to citalopram or placebo in a parallel groups design for 8 weeks of double-blind treatment beginning with 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response is suboptimal and there are no significant side effects.
DRUG	Placebo	Participants will be randomly assigned to citalopram or placebo in a parallel groups design for 8 weeks of double-blind treatment beginning with 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response is suboptimal and there are no significant side effects.

Timeline

• Start date: 2004-07-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2009-08-19
• Last updated: 2020-06-11
• Results posted: 2020-06-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study