Evaluation of Fluoxetine for Refractory Constipation With Somatic Symptom Disorder Features
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorZhifeng Zhao, PhD
About this trial
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?
Eligibility criteria
Qualifiers
None
Disqualifiers
Diagnosis of Functional Constipation (FC): Participants must meet the diagnostic criteria for functional constipation according to Rome IV criteria.
Low CSBM Frequency: During the 2-week screening period, participants must experience Complete Spontaneous Bowel Movements (CSBM) ≤ 2 times per week.
Unsatisfactory Previous Treatments: Participants must have been dissatisfied with previous treatments for functional constipation, having undergone at least 3 months of treatment, including laxatives or other prokinetic agents.
Diagnosis of Somatic Symptom Disorder (SSD): Participants must meet the diagnostic criteria for Somatic Symptom Disorder (SSD) according to DSM-5. All participants will undergo a semi-structured clinical interview based on DSM-5 criteria, conducted by professionals trained in SSD diagnosis.
Trial design
Treatments tested in this trial
- Fluoxetine
- Placebo
Treatment groups
194 Participants
are divided into 2 treatment groupsSponsors and collaborators
Zhifeng Zhao, PhD
Lead sponsor
Xijing Hospital of Digestive Diseases
Sponsor institution
Source ClinicalTrials.gov