Intra-Cellular Therapies shares phase 3 results for major depressive disorder therapy

Betsy Goodfellow | April 17, 2024 | News story | Research and Development |  Intra-Cellular Therapies, Neurology, clinical trial, major depressive disorder, mental health 

Intra-Cellular Therapies has announced positive topline results from Study 501, which assessed lumateperone 42mg as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD).

The drug given once daily as an adjunctive therapy to antidepressants met its primary endpoint in the trial, demonstrating a statistically significant and clinically meaningful reduction in the Montogmer-Asberg Depression Rating Scale (MADRS) total score at week 6 when compared to placebo. It also met its secondary endpoint of reduction in Clinical Global Impression Scale for Severity of Illness (CGI-S) at week 6 compared to placebo.

Topline results from the second phase 3 trial, Study 502, are expected in the second quarter of 2024.

Dr Sharon Mates, chairman and chief executive officer of Intra-Cellular Therapies, commented: “The positive phase 3 results in MDD represent a significant step towards our goal of further establishing Caplyta as a first-choice treatment across mood disorders. We believe that these robust efficacy results, coupled with its favourable safety and tolerability profile and convenient dosing, make Caplyta a compelling option as an adjunctive treatment for MDD, if approved. At Intra-Cellular Therapies, we are committed to bringing improved treatment options to patients with major neuropsychiatric conditions through our efforts to expand Caplyta’s label and advance our pipeline.”

Betsy Goodfellow