Clinical trial NCT00962039: Anxiety and Recurrent Abdominal Pain in Children
Official title: Anxiety and Recurrent Abdominal Pain in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Abdominal Pain
Anxiety
Keywords: Abdominal Pain
Anxiety
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2009-08-19
Enrollment: 81
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: The CGI will be completed at weeks 2, 4, and 8
measure: Clinical Global Impression Scale - Severity (CGI-S)
timeFrame: Weeks 0, 2, 4, and 8
measure: Abdominal Pain Index (API)
timeFrame: Weeks 0, 2, 4, and 8
Secondary outcomes:
measure: Pediatric Anxiety Rating Scale (PARS)
timeFrame: Weeks 0, 2, 4, and 8
measure: Children's Depression Rating Scale - Revised (CDRS-R)
timeFrame: Weeks 0, 2, 4, and 8
measure: Children's Global Assessment Scale (C-GAS)
timeFrame: Weeks 0, 2, 4, and 8
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Research Institute at Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: The Research Institute at Nationwide Children's Hospital
name: John V Campo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.