Evaluation of Fluoxetine in Refractory Constipation With Comorbid Anxiety and Depression Treatment
- Conditions
- Refractory Constipation
- Interventions
- Drug: Placebo
- Registration Number
- NCT06506136
- Lead Sponsor
- Zhifeng Zhao, PhD
- Brief Summary
The goal of this clinical trial is to determine if fluoxetine is effective in treating refractory constipation and comorbid anxiety and depression . It will also assess the safety profile of fluoxetine when used for this condition. The main questions it aims to answer are:
Does fluoxetine improve bowel movement frequency and Complete Spontaneous Bowel Movements (CSBM) in participants with refractory constipation comorbid anxiety and depression? What adverse effects do participants experience while taking fluoxetine? Researchers will compare fluoxetine to a placebo (a look-alike substance that contains no active drug) to evaluate its efficacy and safety in treating chronic constipation.
Participants will:
Take fluoxetine or a placebo daily for 12 weeks Maintain a diary of their CSBM, Spontaneous Bowel Movements (SBM), bowel movements, stool consistency, and any side effects experienced
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 194
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fluoxetine Treatment Group Fluoxetine - Placebo Control Group Placebo -
- Primary Outcome Measures
Name Time Method Efficacy rate of fluoxetine treatment Weeks-2-0, 1, 3, 5, 6, 7, 8，9，10，11，12 The proportion (%) of participants achieving an increase of ≥1 CSBM per week for at least 4 weeks during the 12-week treatment period compared with the screening period. This proportion is a key indicator for assessing the efficacy of treatment for functional constipation (FC). According to the recommendation of the U.S. Food and Drug Administration (FDA), the overall CSBM response rate is considered the primary efficacy endpoint in clinical trials for chronic idiopathic constipation
- Secondary Outcome Measures
Name Time Method Medication adherence Weeks 0-12 The number and proportion of participants with medication adherence rates of \<80%, 80-120%, and \>120%.
Change in PAC-QOL self-assessment scores from baseline Weeks -2-0, 12 A validated constipation-specific quality of life instrument developed to assess the impact of constipation on daily living. It includes 28 items covering four domains: physical discomfort, psychosocial discomfort, worries and concerns, and satisfaction, reflecting the effect of constipation over the past two weeks.
Proportion of participants using rescue medications (polyethylene glycol or enema) and the weekly dosage of rescue medications used Weeks -2-0, 1, 3, 5, 6, 7, 8, 9, 10, 11, 12 Proportion of patients with ≥3 CSBM per week Weeks-2-0, 1, 3, 5, 6, 7, 8，9，10，11，12 Refers to a spontaneous bowel movement that occurs within the past 24 hours, without the aid of medications or external interventions, and is accompanied by a sensation of complete evacuation and satisfaction. Clinically, an increase in the weekly frequency of CSBMs is considered an indicator of treatment efficacy. Achieving ≥3 CSBMs per week is generally regarded as an optimal therapeutic outcome
Change in the SBM compared to baseline over the 12-week treatment period Weeks-2-0, 1, 3, 5, 6, 7, 8，9，10，11，12 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
Change in the average straining score for SBM over 12 weeks compared to baseline Weeks-2-0, 1, 3, 5, 6, 7, 8，9，10，11，12 0 = no difficulty;
1. = mild difficulty, straining required;
2. = moderate difficulty, straining required;
3. = severe difficulty, intense straining required.Change in the abdominal bloating score compared to baseline over the 12-week treatment period Weeks-2-0, 1, 3, 5, 6, 7, 8，9，10，11，12 Abdominal bloating will be assessed using a 5-point ordinal scale:
1. = none;
2. = mild;
3. = moderate;
4. = severe;
5. = very severe.Change in the average stool consistency score for SBM over 12 weeks compared to baseline Weeks -2-0, 1, 3, 5, 6, 7, 8, 9, 10, 11, 12 Participants will self-report the stool consistency of each SBM using the Bristol Stool Form Scale
Time to first CSBM after treatment initiation Weeks-2-12 The number of days from the first administration of fluoxetine to the first occurrence of CSBM. The use of rescue medication will be prohibited within 48 hours after the first dose. If no CSBM occurs within 48 hours, rescue medication may be initiated. However, any CSBM occurring within 24 hours of rescue medication use will not be counted as the first CSBM, and the time count will continue until the first CSBM occurs.
The change in HAMD score from baseline to the end of the treatment period Weeks-2-0, 12 A validated constipation-specific quality of life instrument developed to assess the impact of constipation on daily living. It includes 28 items covering four domains: physical discomfort, psychosocial discomfort, worries and concerns, and satisfaction, reflecting the effect of constipation over the past two weeks.
Incidence of adverse events Weeks-2-12 The proportion of participants experiencing adverse events in each treatment group during the study period.
The change in KESS score from baseline to the end of the treatment period Weeks-2-0, 12 A validated questionnaire designed to quantify the severity and symptom profile of chronic constipation. It consists of 11 items, each scored from 0 to 4 based on symptom severity. Higher total scores indicate more severe constipation symptoms.
The change in HAMA score from baseline to the end of the treatment period Weeks-2-0, 12 A widely used clinical scale for assessing the severity of anxiety symptoms. It consists of 14 items encompassing both psychological (e.g., tension, fears) and somatic (e.g., cardiovascular, gastrointestinal, respiratory) manifestations of anxiety. A score above 29 indicates severe anxiety; above 21 indicates definite anxiety; above 14 suggests probable anxiety; above 7 suggests possible anxiety; and below 7 is considered normal.
Trial Locations
- Locations (2)
People's Hospital of Ningxia Hui Autonomous Region
🇨🇳Yinchuan, Ningxia, China
Xi'an International Medical Center Hospital
🇨🇳Xi'an, Shaanxi, China