Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Fluoxetine in Patients With Refractory Constipation Exhibiting Somatic Symptom Disorder Features
Overview
- Phase
- Phase 1
- Intervention
- Fluoxetine
- Conditions
- Not specified
- Sponsor
- Zhifeng Zhao, PhD
- Enrollment
- 194
- Locations
- 2
- Primary Endpoint
- Efficacy rate of fluoxetine treatment
- Status
- Not yet recruiting
- Last Updated
- 8 months ago
Overview
Brief 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?
Investigators
Zhifeng Zhao, PhD
Dr.
Xijing Hospital of Digestive Diseases
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Fluoxetine Treatment Group
Intervention: Fluoxetine
Placebo Control Group
Intervention: Placebo
Outcomes
Primary Outcomes
Efficacy rate of fluoxetine treatment
Time Frame: Baseline (Week -2) through the end of Week 12 (treatment period)
The primary efficacy endpoint is the proportion (%) of participants who achieve an increase of ≥ 1 complete spontaneous bowel movement (CSBM) per week relative to baseline in at least four of the twelve treatment weeks, a key indicator of therapeutic response in functional constipation (FC).
Secondary Outcomes
- Proportion of Participants Achieving ≥3 CSBM per Week(baseline and 12-week)
- Change in the SBM compared to baseline over the 12-week treatment period(Baseline to Week-12)
- Change from Baseline in Weekly CSBM Frequency(Baseline to Week-12)
- Change in the average straining score for SBM over 12 weeks compared to baseline(Baseline to Week-12)
- Change in the abdominal bloating score compared to baseline over the 12-week treatment period(Baseline to Week-12)
- Change in the average stool consistency score for SBM over 12 weeks compared to baseline(Baseline to Week-12)
- The change in KESS score from baseline to the end of the treatment period(Baseline to Week-12)
- Change in PAC-QOL self-assessment scores from baseline(Baseline to Week-12)
- The change in GAD-7 score from baseline to the end of the treatment period(Baseline to Week-12)
- The change in PHQ-9 score from baseline to the end of the treatment period(Baseline to Week-12)
- The change in PHQ-15 score from baseline to the end of the treatment period(Baseline to Week-12)
- Incidence of adverse events(Weeks-2-12)