Evaluation of Fluoxetine for Refractory Constipation With Somatic Symptom Disorder Features

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

194

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

June 1, 2026

Study Completion Date

May 30, 2027

Conditions
Refractory ConstipationSomatic 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."

Trial Locations (2)

710032

Xi'an International Medical Center Hospital, Xi'an

750021

People's Hospital of Ningxia Hui Autonomous Region, Yinchuan

All Listed Sponsors
lead

Zhifeng Zhao, PhD

OTHER

NCT06506136 - Evaluation of Fluoxetine for Refractory Constipation With Somatic Symptom Disorder Features | Biotech Hunter | Biotech Hunter