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| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00962039 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Abdominal Pain Anxiety |
Drug: Citalopram |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Anxiety and Recurrent Abdominal Pain in Children |
| Estimated Enrollment: | 100 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
| Citalopram: Experimental |
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.
|
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:
Eligibility| Ages Eligible for Study: | 7 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
FAP with atypical features:
Contacts and Locations| Contact: John V Campo, MD | 614-722-2291 | john.campo@nationwidechildrens.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 |
More Information
| Responsible Party: | The Research Institute at Nationwide Children's Hospital ( John V Campo ) |
| Study ID Numbers: | R01 MH069715, DAHBR B4-TBI |
| Study First Received: | August 18, 2009 |
| Last Updated: | August 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT00962039 History of Changes |
| Health Authority: | United States: Federal Government |
|
Abdominal Pain Anxiety |
|
Parasympatholytics Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Signs and Symptoms, Digestive Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Abdominal Pain Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Pain Cholinergic Agents |
Signs and Symptoms Therapeutic Uses Antidepressive Agents, Second-Generation Dexetimide Antidepressive Agents Serotonin Uptake Inhibitors Citalopram Pharmacologic Actions Muscarinic Antagonists Serotonin Agents Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents |