Can an antidepressant unblock stubborn constipation?
NCT ID NCT06506136
First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time
Summary
This trial tests whether fluoxetine, a common antidepressant, can improve bowel function in adults with chronic constipation that has not responded to standard laxatives. Participants also show features of somatic symptom disorder, where emotional distress appears as physical symptoms. Half receive fluoxetine and half receive a placebo for 12 weeks. Researchers measure changes in complete spontaneous bowel movements and use brain scans and anal pressure tests to explore how the drug might work.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fluoxetine
- What this could lead to
- If fluoxetine works, it could offer a new treatment option for people with constipation that does not respond to standard laxatives, especially when psychological factors play a role.
- What could go wrong
- This is a phase 2 trial, so the drug may not prove effective or safe in this larger group. Fluoxetine can cause side effects like nausea, insomnia, or mood changes, and the benefit over placebo is not yet established.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 194 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Sep 2026
An estimate. Start dates often move.
- Expected to finish
-
Sep 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Diagnosis of Functional Constipation (FC): Participants must meet the Rome IV diagnostic criteria for functional constipation. 2. Low CSBM Frequency: During the 2-week screening period, participants must have Complete Spontaneous Bowel Movements (CSBM) ≤ 2 times per week. 3. Refractory to Standard Laxatives: Participants must have documented failure of at least 3 classes of conventional laxatives (e.g., osmotic, stimulant, or prosecretory agents), each administered at standard doses for ≥4 weeks. 4. Diagnosis of Somatic Symptom Disorder (SSD): Participants must meet the DSM-5 diagnostic criteria for Somatic Symptom Disorder, confirmed by the Structured Clinical Interview for DSM-5 (SCID-5), conducted by trained professionals. 5. Age Range: Participants must be between 18 and 70 years of age. 6. No Concurrent Trial Participation: Participants must not be enrolled in any other interventional clinical trial during the study period. 7. Informed Consent: Participants must voluntarily provide written informed consent. Exclusion Criteria: 1. Organic or Secondary Causes: Participants with organic gastrointestinal diseases (e.g., colorectal cancer, Crohn's disease, congenital megacolon), endocrine disorders (e.g., hypothyroidism), metabolic diseases (e.g., diabetes), neurological disorders (e.g., Parkinson's disease), or prior major abdominal surgery (e.g., colectomy, cholecystectomy). 2. Medications Affecting Bowel Function: Participants requiring long-term use of medications known to affect gastrointestinal motility or induce constipation (e.g., antiparkinsonian drugs, opioids), except for routine laxatives. 3. Chronic Pain Requiring Opioids: Participants with chronic pain syndromes unrelated to functional gastrointestinal disorders (e.g., fibromyalgia, severe chronic back pain) who require long-term opioid therapy. 4. Recent Psychotropic Medication Use: Participants who have used any antidepressant, anxiolytic, or antipsychotic medication within 4 weeks prior to screening. 5. Severe Psychiatric Conditions: Participants at risk of self-harm or suicide, or with severe major depressive episode, severe anxiety disorder, bipolar disorder, or schizophrenia spectrum disorders, as assessed by a psychiatrist. 6. Contraindications to Fluoxetine: Participants with a history of hypersensitivity to fluoxetine or other SSRIs, hepatic or renal impairment, or ECG evidence of QTc prolongation. 7. Pregnancy, Lactation, or Planned Pregnancy: Women who are pregnant, breastfeeding, or planning to become pregnant during the study period. 8. Malignancy or Autoimmune Disease: Participants with active malignant or benign tumors, or autoimmune diseases. 9. Severe Comorbidities: Participants with cardiovascular diseases, coagulation disorders (requiring long-term anticoagulation), hepatic or renal failure, organ failure, cognitive impairment, or aphasia, where the chronic condition requires long-term medication affecting quality of life and treatment evaluation. 10. Recent Clinical Trial Participation: Participants who have participated in another interventional clinical trial within 3 months prior to screening.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Functional constipation (FC) are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a sticky pad on the belly replace invasive colon tests for kids?
- Could emotional awareness therapy soothe mysterious body aches?
- Can a Once-Daily pill ease chronic constipation in kids?
- Hands-On healing: could physical therapy be the key to relieving stubborn constipation?
- Smartphone app tests music and thought exercises to reduce daily distress from unexplained physical symptoms
- Constipation in seniors may signal fall risk, new study suggests