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Clinical Trials/ACTRN12612001067864
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.

Registry
who.int
Start Date
October 5, 2012
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity of South Australia

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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