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Evaluation of Fluoxetine for Refractory Constipation With Somatic Symptom Disorder Features

NCT06506136 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2025-08-06

No results posted yet for this study

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?

Conditions

  • Refractory Constipation
  • Somatic Symptom Disorder (DSM-5)
  • Functional Constipation (FC)

Interventions

DRUG

Fluoxetine

Participants 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.

DRUG

Placebo

Participants 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.

Sponsors & Collaborators

  • Zhifeng Zhao, PhD

    lead OTHER

Principal Investigators

  • Qingchuan Zhao, Prof. · Xijing Hospital of Digestive Diseases

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-06-01
Completion
2027-05-30

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06506136 on ClinicalTrials.gov