Fluoxetine for maintenance of remission and to improve quality of life in patients with Crohn's Disease: a pilot randomized placebo-controlled trial

Mikocka-Walus, Antonina, Hughes, Patrick A., Bampton, Peter, Gordon, Andrea, Campaniello, Melissa A., Mavrangelos, Chris, Stewart, Benjamin J., Esterman, Adrian, and Andrews, Jane (2017) Fluoxetine for maintenance of remission and to improve quality of life in patients with Crohn's Disease: a pilot randomized placebo-controlled trial. Journal of Crohn's and Colitis, 11 (4). pp. 509-514.

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Background and Aims: Previous studies have shown that antidepressants reduce inflammation in animal models of colitis. The present trial aimed to examine whether fluoxetine added to standard therapy for Crohn's disease [CD] maintained remission, improved quality of life [QoL] and/or mental health in people with CD as compared to placebo.

Methods: A parallel randomized double-blind placebo controlled trial was conducted. Participants with clinically established CD, with quiescent or only mild disease, were randomly assigned to receive either fluoxetine 20 mg daily or placebo, and followed for 12 months. Participants provided blood and stool samples and completed mental health and QoL questionnaires. Immune functions were assessed by stimulated cytokine secretion [CD3/CD28 stimulation] and flow cytometry for cell type. Linear mixed-effects models were used to compare groups.

Results: Of the 26 participants, 14 were randomized to receive fluoxetine and 12 to placebo. Overall, 14 [54%] participants were male. The mean age was 37.4 [SD=13.2] years. Fluoxetine had no effect on inflammatory bowel disease activity measured using either the Crohn's Disease Activity Index [F(3, 27.5)= 0.064, p=0.978] or faecal calprotectin [F(3, 32.5)=1.08, p=0.371], but did have modest effects on immune function. There was no effect of fluoxetine on physical, psychological, social or environmental QoL, anxiety or depressive symptoms as compared to placebo [all p>0.05].

Conclusions: In this small pilot clinical trial, fluoxetine was not superior to placebo in maintaining remission or improving QoL.

Item ID: 50591
Item Type: Article (Research - C1)
ISSN: 1876-4479
Keywords: antidepressants, Crohn's disease, disease activity, mental health, quality of life
Additional Information:

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited.

Funders: Crohn's and Colitis Foundation of America (CCFA), National Health and Medical Research Council (NHMRC)
Projects and Grants: CCFA grant no. IBD-0352
Date Deposited: 20 Sep 2017 10:15
FoR Codes: 32 BIOMEDICAL AND CLINICAL SCIENCES > 3202 Clinical sciences > 320209 Gastroenterology and hepatology @ 100%
SEO Codes: 92 HEALTH > 9201 Clinical Health (Organs, Diseases and Abnormal Conditions) > 920105 Digestive System Disorders @ 100%
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