Trial reportJournal of Crohn's & colitis2017
Fluoxetine for Maintenance of Remission and to Improve Quality of Life in Patients with Crohn's Disease: a Pilot Randomized Placebo-Controlled Trial.
Trial report in Journal of Crohn's & colitis, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 4 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
30 citing papers in PubMed, 4 syntheses or guidelines pooled it, 55 citations in OpenAlex.
- Psychopharmacological Therapy Positively Modulates Disease Activity in Inflammatory Bowel Disease: A Systematic Review.International journal of molecular sciences · 2025Pooled it
- Do interventions for mood improve inflammatory biomarkers in inflammatory bowel disease?: a systematic review and meta-analysis.EBioMedicine · 2024Pooled it
- Interventions for fatigue in inflammatory bowel disease.The Cochrane database of systematic reviews · 2020Pooled it
- Adjuvant therapy with antidepressants for the management of inflammatory bowel disease.The Cochrane database of systematic reviews · 2019Pooled it
- Fatigue in Inflammatory Bowel Disease: The Role of Drug Therapy Within a Holistic Management Framework.Drugs · 2026Review
- Interplay Between Depression and Inflammatory Bowel Disease: Shared Pathogenetic Mechanisms and Reciprocal Therapeutic Impacts-A Comprehensive Review.Journal of clinical medicine · 2025Review
- Unveiling the Anti-Inflammatory Effects of Antidepressants: A Systematic Review of Human Studies over the Last Decade.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Unraveling the fatigue puzzle: insights into the pathogenesis and management of IBD-related fatigue including the role of the gut-brain axis.Frontiers in medicine · 2024Review
- Chronic abdominal pain in inflammatory bowel disease: a practical guide.Frontline gastroenterology · 2024Review
- Abdominal Pain in Inflammatory Bowel Disease: An Evidence-Based, Multidisciplinary Review.Crohn's & colitis 360 · 2023Article
- Identification and investigation of depression-related molecular subtypes in inflammatory bowel disease and the anti-inflammatory mechanisms of paroxetine.Frontiers in immunology · 2023Article
- Effect of antidepressants on psychological comorbidities, disease activity, and quality of life in inflammatory bowel disease: a systematic review and meta-analysis.Therapeutic advances in gastroenterology · 2023Article
- Depression and anxiety in inflammatory bowel disease: epidemiology, mechanisms and treatment.Nature reviews. Gastroenterology & hepatology · 2022Review
- Antidepressant medication use in Inflammatory Bowel Disease: a nationally representative population-based study.Alimentary pharmacology & therapeutics · 2022Article
- Concurrent functional gastrointestinal disorders in patients with inflammatory bowel disease.Frontiers in gastroenterology (Lausanne, Switzerland) · 2022Review
- Comparison of fluoxetine and duloxetine hydrochloride therapeutic effects on patients with constipation-predominant irritable bowel syndrome.Gastroenterology and hepatology from bed to bench · 2022Article
- Venlafaxine as an Adjuvant Therapy for Inflammatory Bowel Disease Patients With Anxious and Depressive Symptoms: A Randomized Controlled Trial.Frontiers in psychiatry · 2022Article
- Psychological stress in inflammatory bowel disease: Psychoneuroimmunological insights into bidirectional gut-brain communications.Frontiers in immunology · 2022Review
- Tryptophan-derived serotonin-kynurenine balance in immune activation and intestinal inflammation.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2021Review
- Tryptophan-kynurenine metabolism: a link between the gut and brain for depression in inflammatory bowel disease.Journal of neuroinflammation · 2021Review
Corrections and comments
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Authors and funding
9 authors at 6 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
aimsPrevious 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.
methodsA 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.
resultsOf 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].
conclusionsIn this small pilot clinical trial, fluoxetine was not superior to placebo in maintaining remission or improving QoL. [ID: ACTRN12612001067864.].
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.