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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Fluoxetine
DrugParticipants will receive fluoxetine tablets, 40 mg once daily, administered 30 minutes after breakfast for 12 weeks. Emergency Rescue Medications: For participants in both groups who cannot have a bowel movement for three consecutive days or have intolerable symptoms, the following rescue medications will be provided: polyethylene glycol：13.7 g enema Use of rescue medications must be recorded in the bowel movement diary and CRF, including date, time, and dosage. Rescue medications will be provided throughout the study but are not allowed within 48 hours before and after the first treatment. Distributed every two weeks, any bowel movements within 24 hours after rescue medication use will not count as CSBM.
Placebo
DrugParticipants in the Placebo Control Group will receive placebo tablets that are identical in appearance and taste to the fluoxetine tablets. They will take one placebo tablet orally twice a day for 12 weeks, following the same schedule as the treatment group to maintain blinding. Emergency Rescue Medications: For participants in both groups who cannot have a bowel movement for three consecutive days or have intolerable symptoms, the following rescue medications will be provided: polyethylene glycol：13.7 g enema Use of rescue medications must be recorded in the bowel movement diary and CRF, including date, time, and dosage. Rescue medications will be provided throughout the study but are not allowed within 48 hours before and after the first treatment. Distributed every two weeks, any bowel movements within 24 hours after rescue medication use will not count as CSBM.
Treatment groups
194 Participants
are divided into 2 treatment groupsGroup A: Fluoxetine Treatment GroupExperimental treatment 1 intervention
Group B: Placebo Control GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Efficacy rate of fluoxetine treatment
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).
Time frame
Baseline (Week -2) through the end of Week 12 (treatment period)Secondary outcomes
1
Proportion of Participants Achieving ≥3 CSBM per Week
Percentage of participants who achieve at least 3 complete spontaneous bowel movements (CSBM) per week during the 12-week treatment period.
Time frame
baseline and 12-week2
Change in the SBM compared to baseline over the 12-week treatment period
Refers to a bowel movement occurring within the past 24 hours without the use of rescue medications or any other adjunctive methods (e.g., laxatives, enemas, suppositories, or digital maneuvers), including CSBM
Time frame
Baseline to Week-123
Change from Baseline in Weekly CSBM Frequency
The mean change in weekly complete spontaneous bowel movements (CSBM) compared to baseline.
Time frame
Baseline to Week-124
Change in the average straining score for SBM over 12 weeks compared to baseline
0 = no difficulty; 1. = mild difficulty, straining required; 2. = moderate difficulty, straining required; 3. = severe difficulty, intense straining required.
Time frame
Baseline to Week-12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Zhifeng Zhao, PhD
Lead sponsor
Xijing Hospital of Digestive Diseases
Sponsor institution
Source ClinicalTrials.gov
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