Anxiety and Recurrent Abdominal Pain in Children
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Anxiety and Recurrent Abdominal Pain in Children|
- Clinical Global Impression Scale - Improvement (CGI-I) will be used to assess overall global illness improvement. CGI-I scores of 1 ("very much improved") or 2 ("much improved") indicate an acceptable treatment response. [ Time Frame: The CGI will be completed at weeks 0, 2, 4, and 8 ] [ Designated as safety issue: No ]
- Abdominal Pain Index (API) is a well-validated and reliable measure of abdominal pain assessing the frequency, duration, and intensity of abdominal pain over the prior 2 weeks. The API will be a continuous primary outcome measure. [ Time Frame: Weeks 0, 2, 4, and 8 ] [ Designated as safety issue: No ]
|Study Start Date:||July 2004|
|Estimated Study Completion Date:||April 2010|
|Estimated Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
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.
Other Name: Celexa
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.
- Citalopram will be superior to placebo in producing clinical improvement and reductions in abdominal pain.
- Citalopram and placebo will not differ in tolerability or safety.
|Contact: John V Campo, MDfirstname.lastname@example.org|
|United States, Ohio|
|The Research Institute at Nationwide Children's Hospital||Recruiting|
|Columbus, Ohio, United States, 43205|
|Principal Investigator: John V Campo, MD|
|Principal Investigator:||John V Campo, MD||The Research Institute at Nationwide Children's Hospital|