Intra-Cellular Therapies Highlights Lumateperone Presentations at the 59th Annual Meeting of the American College of Neuropsychopharmacology

Presentations highlight lumateperone’s broad antidepressant effects in patients with bipolar disorder and in patients with schizophrenia with co-morbid depression

NEW YORK, Dec. 09, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced two presentations at the 59th Annual Meeting of the American College of Neuropsychopharmacology (ACNP) being held virtually, December 6-9, 2020.

• “Lumateperone (ITI-007) in the Treatment of Bipolar Depression: Efficacy Across Symptoms” (Poster T110).
  

This poster presented additional data from Study 404, a Phase 3 clinical trial evaluating lumateperone as monotherapy for the treatment of patients with bipolar depression. In this Study, lumateperone 42 mg met its primary endpoint of change from baseline at day 43 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score versus placebo (p<.0001; effect size (ES) = 0.56).

A prospective analysis demonstrated lumateperone 42 mg significantly improved each of the 10 individual MADRS items versus placebo (P<.05 to P<.0001) indicating treatment with lumateperone results in reductions in all depression symptom domains.

Data presented also included the categorical shift in severity of depression symptoms as assessed by the MADRS single-item scores. Results showed a higher proportion of lumateperone patients than placebo patients had improvements in overall bipolar illness severity shifting from severe to moderate/mild or no illness. These findings are consistent with the broad antidepressant effects seen with lumateperone in our depression programs.

About the Montgomery-Åsberg Depression Rating Scale¹

The Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item, validated rating scale used to diagnose and rate the severity of depressive episodes and is an accepted regulatory endpoint in clinical trials of depression.

The scale includes questions on the following items: 1. Apparent sadness; 2. Reported sadness; 3. Inner tension; 4. Reduced sleep; 5. Reduced appetite; 6. Concentration difficulties; 7. Lassitude; 8. Inability to feel; 9. Pessimistic thoughts; and 10. Suicidal thoughts. Each item can be scored 0 (no abnormality) to 6 (severe) with the potential overall score ranging from 0 to 60.