Anxiety and Recurrent Abdominal Pain in Children

NCT00962039 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 5R01MH069715-04DAHBR B4-TBI
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Pain; Anxiety

Keywords

Abdominal Pain; Anxiety

Outcome Measures

Primary Outcomes (3)

• 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.

  Clinical Global Impression Scale - Improvement (CGI-I) is a 7-point scale, with lower values being more favorable, used to assess overall global illness improvement. The CGI is a clinician-completed measure, with values ranging from 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), to 7 (very much worse). CGI-I scores of 1 (very much improved) or 2 (much improved) were considered to indicate an acceptable treatment response. A global measure of functional status was chosen as a primary outcome due to the broad array of symptomatology seen in pediatric RAP and the ambiguous relationship between functional status and symptoms of pain, anxiety, and depression in pediatric RAP. The CGI-I is a dichotomous primary outcome measure of global clinical improvement with clinical response be defined as a CGI-I score of 1 or 2 for at least two consecutive weeks.

  The CGI will be completed at weeks 2, 4, and 8

• Clinical Global Impression Scale - Severity (CGI-S)

  Clinical Global Impression Scale - Severity (CGI-S) is a 7-point scale is a clinician-completed measure that requires the clinician to rate the severity of the patient's illness at the time of assessment relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of illness at the time of rating, with values ranging from 1 (normal, not at all ill), 2 (borderline ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), to 7 (extremely ill).

  Weeks 0, 2, 4, and 8

• Abdominal Pain Index (API)

  The API is a well-validated and reliable measure of abdominal pain assessing the frequency, duration, and intensity of abdominal pain consisting of five items assessing the frequency, duration, and intensity of abdominal pain experienced during the prior 2 weeks. Two of the items are scored from 0 to 5, one is scaled 0 to 8, and two are scaled 0 to 10, with lower scores considered to be better than higher scores. Item scores are standardized using Z-scores and then summed to yield an index of abdominal pain that has been sensitive to change in previous epidemiological and treatment studies of FAP. Alpha reliability ranged from 0.80 to 0.93. The API will be a continuous primary outcome measure of abdominal pain.

  Weeks 0, 2, 4, and 8

Secondary Outcomes (3)

• Pediatric Anxiety Rating Scale (PARS)

  Weeks 0, 2, 4, and 8

• Children's Depression Rating Scale - Revised (CDRS-R)

  Weeks 0, 2, 4, and 8

• Children's Global Assessment Scale (C-GAS)

  Weeks 0, 2, 4, and 8

Study Arms (2)

Citalopram

EXPERIMENTAL

Citalopram was initiated at 10 mg daily for one week, with dosage increased to 20 mg daily during week 2, with an optional increase to 40 mg daily at week 4 or thereafter if response was judged to be suboptimal (CGI-I or CGI-S \> 2).

Drug: Citalopram

Placebo

PLACEBO COMPARATOR

Placebo administered in capsules identical to those containing citalopram using microcrystalline cellulose.

Drug: Placebo

Interventions

Citalopram DRUG

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.

Also known as: Celexa

Citalopram

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Physical disease sufficient to explain the subjective distress and functional impairment suffered by the subject.
• FAP with atypical features:
• Abnormal abdominal or rectal examination
• GI bleeding (i.e., hematest positive stool or hematemesis)
• History of recurrent or persistent fever associated with the abdominal pain
• Involuntary weight loss (\> 5% of body weight) over the previous 3 months
• Previous laboratory evidence suggesting explanatory physical disease
• Persistent nighttime awakenings due to abdominal pain (at least once per week and \> 4 per month)
• Persistent or bilious vomiting (at least once per week and \> 4 per month)
• Abdominal pain exclusively associated with menstruation
• 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.

Sponsors & Collaborators

• John V. Campo, M.D.: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

The Research Institute at Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (1)

• 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.

  PMID: 15381890 BACKGROUND

MeSH Terms

Conditions

Abdominal Pain; Anxiety Disorders

Interventions

Citalopram

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Relatively small sample size, potentially without sufficient power to detect meaningful between group differences.

Results Point of Contact

• Title: John V. Campo
• Organization: The Ohio State University

john.campo@hsc.wvu.edu

614-581-5984

Study Officials

• John V Campo, MD

  The Research Institute at Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Of Child & Adolescent Psychiatry -Medical Director

Study Record Dates

• First Submitted: August 18, 2009
• First Posted: August 19, 2009
• Study Start: July 1, 2004
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: June 11, 2020
• Results First Posted: June 11, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)