| City: |
|
Columbus |
|
State:
|
|
OH |
| Zip Code: |
|
43205 |
| Conditions: |
|
Abdominal Pain - Anxiety |
| 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.
|
| Study summary: |
|
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. |
| 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. |
|
|
|
| Study is available at: |
|
The Research Institute at Nationwide Children's Hospital
Columbus, OH 43205
United States
Primary Contact:
John V Campo, MD
Email: john.campo@nationwidechildrens.org
Phone: 614-722-2291 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
March 23, 2011 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|