Safety of BI 1358894 in Patients with Major Depressive Disorder
Overview of the Study
This study explored the effectiveness of a fully remote clinical trial for patients with major depressive disorder (MDD). It aimed to gather insights for better future trials.
Trial Details
- The trial was double-blind and placebo-controlled.
- It involved adult patients who did not respond well to first-line antidepressants.
- Patients were given either BI 1358894 (125 mg) or a placebo daily for 6 weeks.
Key Findings
- The trial had a good execution of protocol, but was stopped early due to low enrollment.
- Out of 136 patients screened, only 45 were randomized, with 43 completing treatment.
- The average age of participants was 42.2 years, with a majority (83.7%) being female.
- 86% of patients reported adverse events, with a higher percentage in the BI 1358894 group (90%).
- 88% of participants had a positive experience with the remote trial.
Learnings for Future Trials
The study highlighted the importance of:
- Streamlining eligibility criteria.
- Using effective recruitment strategies.
- Understanding the pros and cons of digital technology in trials.
Practical Solutions and Value
Conducting a fully remote clinical trial for MDD is feasible and well-received by patients. Future trials should consider the insights gained about recruitment and design to improve outcomes.
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