Safety and Efficacy of Cariprazine As Adjunctive Therapy In Major Depressive Disorder

The patient is rated on a scale from 0-6 on 10 items. Apparent sadness, reported sadness, lassitude, pessimistic thoughts, inner tension, suicidal thoughts, reduced sleep and appetite, concentration difficulties, inability to feel. The overall MADRS score ranges from 0-60, with 0 meaning no symptoms and score of 60 meaning maximum severity. The primary efficacy parameter was the change in MADRS score totals from the scores taken at Baseline (Week 8) and during at least one more time point up to and including Week 16.

Time frame: Baseline (Week 8) to Week 16

Population: 231 patients were randomized, and of them, 230 received at least 1 dose of treatment (Double-blind Safety Population), and had at least a baseline and 1 post-baseline MADRS assessment (Double-blind Intent To Treat Population). All patients in the Double-blind Intent To Treat Population were included in the efficacy analyses.

The Clinical Global Impression-Improvement (CGI-I) scale is a clinician rated scale that, in this study, will be used to rate total improvement or worsening of mental illness starting at Visit 2 (Week 2) and taken at every visit through Visit 11 (Week 16). The patient will be rated on a scale from 1 to 7, 1 indicating that the patient is very much improved and 7 indicating that the patient is very much worse. The secondary efficacy parameter was the CGI-I total score at Week 16.

Time frame: Week 16

Population: 231 patients were randomized, and of them, 230 received at least 1 dose of treatment (Double-blind Safety Population), and had at least a baseline and 1 post-baseline MADRS assessment (Double-blind Intent To Treat Population). All patients in the Double-blind Intent To Treat Population were included in the efficacy analyses.