Fluoxetine for Maintenance of Remission and to Improve Quality of Life in Patients with Crohn's Disease: a Pilot Randomized Placebo-Controlled Trial.
OBJECTIVE
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. [ID: ACTRN12612001067864.].
School of Nursing and Midwifery, University of South Australia, Adelaide, Australia.|Department of Health Sciences, University of York, York, UK.|School of Psychology, University of Adelaide, Adelaide, Australia.|School of Psychology, Deakin University, Burwood, Australia.
Antonina
A
Mikocka-Walus
Centre for Nutrition and Gastrointestinal Diseases, School of Medicine, University of Adelaide and South Australian Health and Medical Research Institute (SAHMRI), Adelaide, Australia.
Patrick A
PA
Hughes
Department of Gastroenterology and Hepatology, Flinders Medical Centre, Bedford Park, Australia.
Peter
P
Bampton
School of Nursing and Midwifery, University of South Australia, Adelaide, Australia.
Andrea
A
Gordon
Centre for Nutrition and Gastrointestinal Diseases, School of Medicine, University of Adelaide and South Australian Health and Medical Research Institute (SAHMRI), Adelaide, Australia.
Melissa A
MA
Campaniello
Centre for Nutrition and Gastrointestinal Diseases, School of Medicine, University of Adelaide and South Australian Health and Medical Research Institute (SAHMRI), Adelaide, Australia.
Chris
C
Mavrangelos
School of Psychology, University of Adelaide, Adelaide, Australia.
Benjamin J
BJ
Stewart
School of Nursing and Midwifery, University of South Australia, Adelaide, Australia.|Australian Institute of Tropical Health and Medicine, James Cook University, Townsville, Australia.
Adrian
A
Esterman
Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Adelaide, Australia.|School of Medicine, Faculty of Health Sciences, University of Adelaide, Adelaide, Australia.
Jane M
JM
Andrews
D000328:Adult; D018687:Antidepressive Agents, Second-Generation / Q000627:therapeutic use*; D003424:Crohn Disease / Q000188:drug therapy*; D016207:Cytokines / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D005434:Flow Cytometry; D005473:Fluoxetine / Q000627:therapeutic use*; D006801:Humans; D007111:Immunity, Cellular / Q000187:drug effects; D008297:Male; D010865:Pilot Projects; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D018687:Antidepressive Agents, Second-Generation; D016207:Cytokines; D005473:Fluoxetine
Antidepressants; Crohn’s disease; disease activity; mental health; quality of life
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