Trial · NCT00962039
Anxiety and Recurrent Abdominal Pain in Children
NCT00962039, Phase 2, Phase 3, Completed, John V. Campo, M.D.; results first posted 2020-06-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Anxiety and Recurrent Abdominal Pain in Children. Trials, record NCT00962039. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00962039
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Anxiety and Recurrent Abdominal Pain in Children
- NCT number
- NCT00962039
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 81 participants, actual
- Lead sponsor
- John V. Campo, M.D.
- Conditions
- Abdominal Pain, Anxiety
- Interventions
- Citalopram, Placebo
- First posted
- 2009-08-19
- Last updated
- 2020-06-11
- Results first posted
- 2020-06-11
- Limitations and caveats
- Relatively small sample size, potentially without sufficient power to detect meaningful between group differences.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. | The CGI will be completed at weeks 2, 4, and 8 | 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. |
| Primary | Clinical Global Impression Scale - Severity (CGI-S) | Weeks 0, 2, 4, and 8 | 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). |
| Primary | Abdominal Pain Index (API) | Weeks 0, 2, 4, and 8 | 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. |
| Secondary | Pediatric Anxiety Rating Scale (PARS) | Weeks 0, 2, 4, and 8 | Pediatric Anxiety Rating Scale (PARS) is a clinician administered measure of anxiety in children and adolescents. The PARS is comprised of a 50-item symptom checklist used to determine the presence or absence of specific anxiety symptoms during the prior week and 7 severity/impairment items, each scored from 0 to 5 . The the score on the 7 items allows the clinician to rate symptom severity and associated impairment on a range from 0 to 35, with higher scores reflecting greater symptom severity and associated impairment. The PARS is characterized by high interrater reliability (ICC = 0.97), adequate internal consistency (α = 0.64), and fair test-retest reliability (ICC = 0.55). There is preliminary support for convergent and divergent validity, and the PARS has demonstrated sensitivity to treatment effects in previously conducted clinical trials. |
| Secondary | Children's Depression Rating Scale - Revised (CDRS-R) | Weeks 0, 2, 4, and 8 | Children's Depression Rating Scale - Revised (CDRS-R) is a clinician administered measure of depression in children and adolescents and provides data necessary to diagnose depressive disorder and rate the severity of depressive symptoms over time. The CDRS-R is composed of 17 items, most rated on a 1 to 7 scale, with a minimum score of 17 and a maximum of 113. Higher scores reflect greater depression severity, with scores of 40 and above generally considered to be reflective of a depressive diagnosis. |
| Secondary | Children's Global Assessment Scale (C-GAS) | Weeks 0, 2, 4, and 8 | Children's Global Assessment Scale (C-GAS) is an interview-based adaptation of the Global Assessment Scale developed to assess child and adolescent functioning during a specified time period. Scores range from one to 100, with scores of 70 or below reflecting abnormally low functioning and higher scores reflecting better functioning. The C-GAS has demonstrated reliability, as well as discriminant and concurrent validity. A CGAS score of \< 70 will be a requirement at study entry. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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. | The CGI will be completed at weeks 2, 4, and 8 | Analysis week 8 | units on a scale | MEAN |
| PRIMARY | Clinical Global Impression Scale - Severity (CGI-S) | Weeks 0, 2, 4, and 8 | Analysis week 8 | units on a scale | MEAN |
| PRIMARY | Abdominal Pain Index (API) | Weeks 0, 2, 4, and 8 | Analysis week 8 | score on a scale | MEAN |
| SECONDARY | Pediatric Anxiety Rating Scale (PARS) | Weeks 0, 2, 4, and 8 | Analysis week 8 | units on a scale | MEAN |
| SECONDARY | Children's Depression Rating Scale - Revised (CDRS-R) | Weeks 0, 2, 4, and 8 | Analysis week 8 | units on a scale | MEAN |
| SECONDARY | Children's Global Assessment Scale (C-GAS) | Weeks 0, 2, 4, and 8 | Analysis week 8 | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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. | Citalopram | CGI-I Week 2 | 3.48 | 95% Confidence Interval 3.25 to 3.72 | units on a scale |
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. | Placebo | CGI-I Week 2 | 3.68 | 95% Confidence Interval 3.44 to 3.93 | units on a scale |
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. | Citalopram | CGI-I Week 4 | 3.03 | 95% Confidence Interval 2.78 to 3.28 | units on a scale |
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. | Placebo | CGI-I Week 4 | 3.38 | 95% Confidence Interval 3.09 to 3.67 | units on a scale |
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. | Citalopram | CGI-I Week 8 | 2.65 | 95% Confidence Interval 2.23 to 3.07 | units on a scale |
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. | Placebo | CGI-I Week 8 | 3.24 | 95% Confidence Interval 2.88 to 3.61 | units on a scale |
| Clinical Global Impression Scale - Severity (CGI-S) | Citalopram | CGI-S Week 0 | 4.31 | 95% Confidence Interval 3.93 to 4.69 | units on a scale |
| Clinical Global Impression Scale - Severity (CGI-S) | Placebo | CGI-S Week 0 | 4.39 | 95% Confidence Interval 4.14 to 4.64 | units on a scale |
| Clinical Global Impression Scale - Severity (CGI-S) | Citalopram | CGI-S Week 2 | 3.83 | 95% Confidence Interval 3.45 to 4.21 | units on a scale |
| Clinical Global Impression Scale - Severity (CGI-S) | Placebo | CGI-S Week 2 | 4.03 | 95% Confidence Interval 3.70 to 4.35 | units on a scale |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Citalopram | 40 | |
| Overall Study | STARTED | Placebo | 41 | |
| Overall Study | COMPLETED | Citalopram | 35 | |
| Overall Study | COMPLETED | Placebo | 37 | |
| Overall Study | NOT COMPLETED | Citalopram | 5 | |
| Overall Study | NOT COMPLETED | Placebo | 4 |
Source ClinicalTrials.gov
Adverse events66
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | gastric distress | Gastrointestinal disorders | Citalopram | 13 | 40 | |
| other | gastric distress | Gastrointestinal disorders | Placebo | 14 | 41 | |
| other | appetite or weight change | Metabolism and nutrition disorders | Citalopram | 11 | 40 | |
| other | appetite or weight change | Metabolism and nutrition disorders | Placebo | 20 | 41 | |
| other | vision disturbance | Eye disorders | Citalopram | 2 | 40 | |
| other | vision disturbance | Eye disorders | Placebo | 3 | 41 | |
| other | dizziness | Nervous system disorders | Citalopram | 16 | 40 | |
| other | dizziness | Nervous system disorders | Placebo | 16 | 41 | |
| other | headache | Nervous system disorders | Citalopram | 31 | 40 | |
| other | headache | Nervous system disorders | Placebo | 36 | 41 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Citalopram | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Citalopram | 31 | 40 |
| Total, other adverse events | Placebo | 36 | 41 |
| Total, serious adverse events | Citalopram | 0 | 40 |
| Total, serious adverse events | Placebo | 0 | 41 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 15381890 | BACKGROUND |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01MH069715 | Anxiety and Recurrent Abdominal Pain in Children | CAMPO, JOHN VINCENT | RESEARCH INST NATIONWIDE CHILDREN'S HOSP | NATIONAL INSTITUTE OF MENTAL HEALTH | 2004 to 2007 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Citalopram vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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