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Elobixibat improved constipation in schizophrenia or depression patients during postmarketing surveillance in JapanNew Hope for Constipation in Mental Health Patients

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Key Takeaway
Consider elobixibat for chronic constipation in schizophrenia or depression; diarrhea was the most common adverse event.

This postmarketing surveillance cohort study assessed the safety and effectiveness of elobixibat in patients with chronic constipation and concomitant schizophrenia or depression in Japan. The population included 105 patients with schizophrenia and 129 with depression in the 4-week treatment groups, and 43 patients with schizophrenia and 55 with depression in the 52-week treatment groups.

Regarding effectiveness, defecation frequency in the schizophrenia 4-week group increased from 3.3 at baseline to 5.3 at week 4. In the depression 4-week group, frequency increased from 3.0 at baseline to 4.9 at week 4. Mean defecation frequency per week at week 52 was higher than baseline in the 52-week groups. The proportion of patients achieving an ideal Bristol Stool Form Scale score of 4 increased in all groups by week 2 and reached approximately 60% by week 52. Constipation-related symptoms improved by week 2 in all groups.

Safety analysis revealed adverse events in 4.76% of patients with schizophrenia in the 4-week treatment group and 2.33% in the 52-week treatment group. Among patients with depression, adverse events occurred in 3.88% and 9.09% of patients in the respective groups. Diarrhea was the most common adverse drug reaction. No serious adverse events were reported, and no new safety signal was identified.

Key limitations include that little is known about the optimal treatment for constipation in patients with schizophrenia or depression. The study design does not explicitly distinguish association from causation, and surrogate versus clinical outcomes were not explicitly distinguished. Practice relevance suggests elobixibat improved chronic constipation with no new safety signal identified in patients with schizophrenia or depression and with available follow-up in real-world settings.

  • Elobixibat boosts bowel movements in schizophrenia and depression
  • Helps people on hard-to-tolerate psychiatric meds
  • Already in use in Japan — not yet in U.S.

This drug eases a hidden burden millions face but rarely talk about.

It starts with a sigh. “I just feel so bloated,” says Yuki, a 42-year-old woman in Osaka who’s lived with depression for over a decade. “Some days, I can’t even leave the house.” She’s not alone. Millions with mental health conditions also battle chronic constipation — a side effect of the very medications that help stabilize their mood or thoughts.

But now, a new real-world study offers fresh hope.

Constipation isn’t just uncomfortable. For people with schizophrenia or depression, it can make everything worse. Low energy, poor appetite, even mood swings — all can be tied to digestive struggles.

And it’s shockingly common. Up to 60% of people on antipsychotics or antidepressants report constipation. Some go days without a bowel movement.

Current treatments? Laxatives like polyethylene glycol or senna. But many don’t work well long-term. Others cause cramps or dependency. And few studies have looked at what works specifically for people with mental illness.

That’s been a major gap — until now.

The surprising shift

For years, doctors assumed constipation in these patients was just from inactivity or poor diet. But science now shows it’s largely drug-induced. Antipsychotics slow gut movement like a traffic jam in the intestines.

But here’s the twist: a new type of laxative may work with the body’s natural system — not against it.

Enter elobixibat.

Think of your gut like a river. Bile is the current that helps push waste downstream. Normally, your body reabsorbs bile in the small intestine to reuse it.

Elobixibat blocks that reabsorption — like opening a dam. More bile flows into the colon. That draws water in (osmotic effect) and gently stimulates movement (stimulant effect).

It’s a dual-action flush — natural, but boosted.

Researchers tracked over 300 patients in Japan with schizophrenia or depression who had chronic constipation. All started elobixibat and were followed for either 4 weeks or a full year.

No placebo. No randomization. This was real-world use — exactly how doctors prescribe it in clinics.

After just four weeks, bowel movements jumped from about 3 per week to nearly 5. That’s a 60% increase — like going from skipping meals to eating regularly.

By week 52, most patients were having near-daily bowel movements.

And it wasn’t just frequency. Stool quality improved fast. The number of people with ideal, easy-to-pass stools (Bristol Scale Type 4) rose to about 60% within a year.

All constipation symptoms — bloating, straining, feeling incomplete — got better by week 2.

This doesn’t mean this treatment is available yet.

But there’s a catch.

Safety was excellent — but not perfect. About 4–9% of patients had side effects. Most common? Diarrhea. But it was mild and didn’t last long.

No serious reactions were linked to the drug. Even better: no mental health worsening — a key concern when treating people with schizophrenia or depression.

That’s huge. It means this drug doesn’t interfere with psychiatric stability.

What scientists didn’t expect

Experts thought long-term use might cause problems. But the one-year group actually had fewer side effects than the short-term group.

Why? Possibly because doses were adjusted over time. Or because the gut adapted.

Either way, it suggests elobixibat may be safer with longer use — not riskier.

If you or a loved one has schizophrenia or depression and struggles with constipation, this drug may be worth discussing with your doctor — especially if other laxatives haven’t worked.

But be clear: elobixibat is not approved in the U.S. or Europe. It’s only available in Japan and a few Asian countries.

And it’s not for everyone. People with bowel obstructions or severe liver disease should avoid it.

Still, for many, it could be a game-changer in daily comfort and quality of life.

The hidden burden

“We often focus only on the mind in mental health,” says a gastroenterologist not involved in the study. “But the gut is part of the picture. When patients feel physically better, they’re more likely to stick with treatment.”

That’s the quiet win here: improving comfort may help people stay on their life-saving psychiatric meds.

This wasn’t a controlled trial. There was no placebo group. So we can’t say for sure how much of the improvement was due to the drug versus other factors.

Also, all patients were Japanese. Results may differ in other populations.

And because it was post-marketing surveillance, some data were self-reported.

What happens next

More rigorous trials are needed — especially outside Japan. Scientists will watch for rare side effects and test how it works in diverse groups.

Drug makers may seek approval in other countries, but that could take years.

For now, this is a strong signal: treating constipation in mental health isn’t just about comfort. It’s part of care.

Study Details

Study typeCohort
EvidenceLevel 3
PublishedApr 2026
View Original Abstract ↓
BackgroundLittle is known about the optimal treatment for constipation in patients with schizophrenia or depression. Elobixibat is a laxative with a novel mechanism of action that inhibits the ileal bile acid transporter, acting as both an osmotic and a stimulant agent.MethodsWe conducted a prospective, multicenter, postmarketing surveillance study to assess the safety and effectiveness of elobixibat for patients with chronic constipation in Japan (jRCT1080223950). The surveillance period was between June 2018 and May 2022. Patients were observed from the date of initial administration of elobixibat to 55 days thereafter (4-week treatment groups) or to 419 days thereafter (52-week treatment groups). Safety outcomes included adverse drug reactions (ADRs). Effectiveness outcomes included defecation frequency, Bristol Stool Form Scale (BSFS) scores, and constipation-related symptoms.ResultsIn the safety analysis set, the 4-week treatment groups comprised 105 patients with schizophrenia and 129 with depression; the 52-week treatment groups included 43 patients with schizophrenia and 55 with depression. Approximately 85% to 95% of patients used antipsychotics, and 40% to 55% used anxiolytics or sedative-hypnotics. The proportions of patients who experienced ADRs were 4.76% in the 4-week treatment group and 2.33% in the 52-week treatment group of patients with schizophrenia, and 3.88% and 9.09% of patients with depression. Diarrhea was the most common ADR in each group. There were no serious ADRs. In the 4-week treatment groups, the mean defecation frequency per week at baseline was 3.3 among patients with schizophrenia and 3.0 among patients with depression, which increased to 5.3 and 4.9, respectively, at week 4. In the 52-week treatment groups, the mean defecation frequency per week at week 52 was higher than that at baseline. After treatment, the proportion of patients with an ideal BSFS score of 4 increased in all groups by week 2 and reached approximately 60% by week 52. All constipation-related symptoms also improved by week 2 in all groups.ConclusionsElobixibat improved chronic constipation with no new safety signal identified in patients with schizophrenia or depression and with available follow-up in real-world settings.Clinical trial registrationhttps://jrct.mhlw.go.jp/latest-detail/jRCT1080223950, identifier jRCT1080223950.
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