Can an antidepressant unblock stubborn constipation?

NCT ID NCT06506136

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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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

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.

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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

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