What type of study is this?

This is a Phase 2 study (also classified as: Randomized).

September 10, 2025The Journal of Clinical Psychiatry

Efficacy, Tolerability, and Safety of TRPC4/5 Inhibitor BI 1358894 in Patients With Major Depressive Disorder and Inadequate Response to Antidepressants

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Authors

RSRichard C. SheltonUniversity of Alabama at Birmingham Hospital DPDiego A. Pizzagalli ECElan A. CohenHassman Research Institute

Discussion

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Implication

Phase 2 trial shows no efficacy of TRPC4/5 inhibitor BI 1358894 against placebo in major depressive disorder, implying it may not address inadequate antidepressant response.

Key Points

No significant efficacy differences were found between BI 1358894 and placebo in treating major depressive disorder.
Adverse events were reported in 66.7% of the BI 1358894 group compared to 53.9% in placebo.
The trial utilized a multicenter, randomized, double-blind design with a focus on treatment response over six weeks.
While the trial did not establish proof-of-concept, BI 1358894 was generally well tolerated with no marked increase in suicidality.

Cite This Study

Shelton et al. (2025) studied this question.

synapsesocial.com/papers/68c187209b7b07f3a0610f43 https://doi.org/10.4088/jcp.25m15868

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Implication

Phase 2 trial shows no efficacy of TRPC4/5 inhibitor BI 1358894 against placebo in major depressive disorder, implying it may not address inadequate antidepressant response.

Efficacy, Tolerability, and Safety of TRPC4/5 Inhibitor BI 1358894 in Patients With Major Depressive Disorder and Inadequate Response to Antidepressants

Discussion

Member takes

Implication

Key Points

Cite This Study

Efficacy, Tolerability, and Safety of TRPC4/5 Inhibitor BI 1358894 in Patients With Major Depressive Disorder and Inadequate Response to Antidepressants

Discussion

Member takes

Implication

Key Points

Cite This Study

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