Anxiety and Recurrent Abdominal Pain in Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by National Institute of Mental Health (NIMH).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00962039
First received: August 18, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  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 2
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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
Experimental: Citalopram 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.
Other Name: Celexa

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.
  Eligibility

Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 3 episodes of abdominal pain during the previous 3 months associated with functional impairment in the absence of explanatory physical disease following clinically appropriate medical assessment.
  • Age 7 years 0 months to 18 years 11 months, inclusive, at initial evaluation.
  • Significant global functional impairment as reflected by a score less than 70 on the Children's Global Assessment Scale
  • Residing with a primary caretaker (i.e., parent, legal guardian, relative functioning as a parent, or foster parent) who has known the child well for at least 6 months prior to study entry and has legal authority to consent to participation.

Exclusion Criteria:

  • Physical disease sufficient to explain the subjective distress and functional impairment suffered by the subject.
  • FAP with atypical features:

    1. Abnormal abdominal or rectal examination
    2. GI bleeding (i.e., hematest positive stool or hematemesis)
    3. History of recurrent or persistent fever associated with the abdominal pain
    4. Involuntary weight loss (> 5% of body weight) over the previous 3 months
    5. Previous laboratory evidence suggesting explanatory physical disease
    6. Persistent nighttime awakenings due to abdominal pain (at least once per week and > 4 per month)
    7. Persistent or bilious vomiting (at least once per week and > 4 per month)
    8. Abdominal pain exclusively associated with menstruation
    9. Dysuria
  • Physical disease in which citalopram monotherapy or study participation might prove to be disadvantageous or incompatible with quality care, including bleeding disorder characterized by prolonged bleeding time, uncontrolled epilepsy, or poorly controlled diabetes mellitus.
  • Psychiatric problem or disorder in which citalopram monotherapy or study participation might prove to be disadvantageous or incompatible with quality care, including evidence that the child is a serious acute danger to self or others, anorexia nervosa, bulimia nervosa, schizophrenia, schizoaffective disorder, alcohol or substance abuse/dependence, or bipolar disorder.
  • History of mental retardation as defined by full scale IQ < 70 on previous testing or participation in special education placement for mild to severe mental retardation.
  • Inadequate English speaking abilities of child or parent(s) to complete study measures and/or communicate with study examiners.
  • Adequate prior trial of citalopram, escitalopram, or another selective serotonin reuptake inhibitor or venlafaxine. Adequate trial is defined as at least 4 weeks of citalopram 20 mg/day, escitalopram 10 mg/day, fluoxetine 20 mg/day, fluvoxamine 100 mg/day, paroxetine 20 mg/day, sertraline 50 mg/day, or venlafaxine 75 mg/day.
  • Concurrent use of non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, or anticoagulant medications.
  • Treatment for physical or psychiatric illness initiated within the prior 4 weeks or escalating in dosage or intensity.
  • History of hypersensitivity to citalopram or serotonin-syndrome.
  • Participation in any investigational drug study within thirty days of study entry.
  • Pregnancy
  • Sexually active female subjects refusing to use a medically accepted method of birth control during the study, or who engaged in unprotected sexual activity during the 30 days prior to the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00962039

Contacts
Contact: John V Campo, MD 614-722-2291 john.campo@nationwidechildrens.org

Locations
United States, Ohio
The Research Institute at Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Principal Investigator: John V Campo, MD         
Sponsors and Collaborators
Investigators
Principal Investigator: John V Campo, MD The Research Institute at Nationwide Children's Hospital
  More Information

Additional Information:
Publications:
Responsible Party: John V Campo, The Research Institute at Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT00962039     History of Changes
Other Study ID Numbers: R01 MH069715, DAHBR B4-TBI
Study First Received: August 18, 2009
Last Updated: August 18, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Abdominal Pain
Anxiety

Additional relevant MeSH terms:
Anxiety Disorders
Abdominal Pain
Mental Disorders
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on October 16, 2014