Anxiety and Recurrent Abdominal Pain in Children

NCT00962039 ↗

Phase 2/3 Completed 81 enrolled John V. Campo, M.D. National Institute of Mental Health (NIMH) · collab

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2004-07
Primary completion: 2010-04
Completion: 2010-04

Outcome

Mixed primary results

registry analysis (unspecified test); Citalopram vs Placebo; p = 0.92; Mean Difference (Net) -0.01 (95% CI -0.12 to 0.10); Chi-squared NCT00962039 ↗

registry analysis (unspecified test); Citalopram vs Placebo; p = 0.034; Mean Difference (Net) -0.08 (95% CI -0.15 to -0.01); Chi-squared NCT00962039 ↗

registry analysis (unspecified test); Citalopram vs Placebo; p = 0.261; Mean Difference (Net) -0.03 (95% CI -0.07 to 0.02); t-test, 2 sided NCT00962039 ↗

Publications

Background Campo JV, Perel J, Lucas A, Bridge J, Ehmann M, Kalas C, Monk K, Axelson D, Birmaher B, Ryan N, Di Lorenzo C, Brent DA. Citalopram treatment of pediatric recurrent abdominal pain and comorbid internalizing disorders: an exploratory study. J Am Acad Child Adolesc Psychiatry. 2004 Oct;43(10):1234-42. doi: 10.1097/01.chi.0000136563.31709.b0.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Citalopram	Small molecule	20 mg	—
Subject	Citalopram	Small molecule	40 mg	—