ACTRN12612001067864
Completed
Phase 4
A randomised controlled pilot trial to evaluate the efficacy of fluoxetine in maintaining remission in Crohn's disease
niversity of South Australia0 sites52 target enrollmentOctober 5, 2012
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- inflammatory bowel disease
- Sponsor
- niversity of South Australia
- Enrollment
- 52
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria
- •Patients had to meet ALL of the following criteria:
- •1\). Established diagnosis of CD;
- •2\). Remission or only mild symptoms of CD (CDAI \<150\);
- •3\). Have flared CD in the last 12 months (as documented by their treating doctor and demonstrated by either raised inflammatory markers, augmented therapy, high CDAI or calprotectin);
- •4\). Be on stable dose of all their current CD therapies for 12 weeks;
- •5\). Be 18 years old or older;
- •6\). Have a sufficient knowledge of English to understand and answer questionnaires.
- •7\). Have the ability to consent to the study.
Exclusion Criteria
- •Exclusion criteria
- •Patients were excluded if they met ANY of the following:
- •1\). Have serious uncontrolled mental illness (e.g. schizophrenia) or are alcohol/substance dependant;
- •2\). Currently taking antidepressants;
- •3\). Currently receiving psychotherapy;
- •4\). Currently taking steroids \>15mg or equivalent;
- •5\). Are allergic to fluoxetine or any component of placebo;
- •6\). Are pregnant or breastfeeding;
- •7\). Have cognitive impairment.
Outcomes
Primary Outcomes
Not specified
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