Objective:

To assess the safety and effectiveness of elobixibat for treating chronic constipation specifically in patients with schizophrenia or depression.

Key Findings:

• 4-week treatment groups: 105 patients with schizophrenia and 129 with depression.
• 52-week groups: 43 with schizophrenia and 55 with depression.
• ADRs were reported in 4.76% (4-week) and 2.33% (52-week) of schizophrenia patients, and 3.88% (4-week) and 9.09% (52-week) of depression patients.
• Diarrhea was the most common ADR, with no serious ADRs reported.
• Defecation frequency increased from 3.3 to 5.3 (schizophrenia) and 3.0 to 4.9 (depression) in the 4-week groups.
• By week 52, approximately 60% of patients achieved an ideal BSFS score of 4, with improvements in all constipation-related symptoms by week 2.

Interpretation:

Elobixibat effectively improved chronic constipation in patients with schizophrenia or depression without new safety concerns.

Limitations:

• The study did not use study-specific criteria for diagnosing schizophrenia or depression, which may affect the reliability of the findings.
• The observational nature may limit the generalizability of findings.

Conclusion:

Elobixibat is a safe and effective treatment for chronic constipation in patients with schizophrenia or depression, with significant improvements observed in defecation frequency and stool consistency.