Evaluation of Fluoxetine for Refractory Constipation With Somatic Symptom Disorder Features (NCT06506136) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Evaluation of Fluoxetine for Refractory Constipation With Somatic Symptom Disorder Features
China194 participantsStarted 2025-09-01
Plain-language 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 ā„ 10) in the absence of IBS-C abdominal pain criteria.
The study will address three primary questions:
Efficacy-Bowel Function:
ā¢ Does 12 weeks of fluoxetine increase Complete Spontaneous Bowel Movements (CSBM) and overall bowel-movement frequency compared with placebo?
Efficacy-Somatic Symptom Burden:
ā¢ 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:
ā¢ What adverse events occur during fluoxetine treatment, and how do their incidence and intensity compare with placebo?
Who can participate
Age range18 Years ā 60 Years
SexALL
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Exclusion criteria
ā. Diagnosis of Functional Constipation (FC): Participants must meet the diagnostic criteria for functional constipation according to Rome IV criteria.
ā. Low CSBM Frequency: During the 2-week screening period, participants must experience Complete Spontaneous Bowel Movements (CSBM) ā¤ 2 times per week.
ā. 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.
ā. 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.
ā.1. Criterion A: One or more physical symptoms that cause significant discomfort and/or disruption in daily life.
ā.2. Criterion B: At least one of the following: 1) Excessive and persistent thoughts about the severity of symptoms. 2) Persistent high anxiety about health or symptoms. 3) Excessive time and energy spent on health concerns or symptoms.
ā.3. Criterion C: The symptoms have persisted for at least 6 months.
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What they're measuring
1
Efficacy rate of fluoxetine treatment
Timeframe: Baseline (Week -2) through the end of Week 12 (treatment period)