Evaluation of Fluoxetine for Refractory Constipation With Somatic Symptom Disorder Features
Status:
NOT_YET_RECRUITING
Trial end date:
2027-05-30
Target enrollment:
Participant gender:
Summary
The purpose of this randomized, double-blind, placebo-controlled trial is to determine whether fluoxetine is effective and safe for adults with refractory constipation that exhibits Somatic Symptom Disorder (SSD) features-namely, persistent preoccupation with bowel function, heightened perception of defecatory discomfort, and clinically significant somatic symptom burden (PHQ-15 ≥ 10) in the absence of IBS-C abdominal pain criteria.
The study will address three primary questions:
Efficacy-Bowel Function:
• Does 12 weeks of fluoxetine increase Complete Spontaneous Bowel Movements (CSBM) and overall bowel-movement frequency compared with placebo?
Efficacy-Somatic Symptom Burden:
• Does fluoxetine reduce SSD severity, as measured by the Patient Health Questionnaire-15 (PHQ-15) and the Somatic Symptom Scale-8 (SSS-8)?
Safety and Tolerability:
• What adverse events occur during fluoxetine treatment, and how do their incidence and intensity compare with placebo?