A Randomized, Double-Blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Lumateperone as Adjunctive Therapy in the Treatment of Patients with Major Depressive Disorder (ITI-007-505)

Conditions

Major Depressive Disorder

Brief summary

Change from Baseline (Visit 2) to Day 43 (Visit 8) in MADRS total score.

Detailed description

Key secondary efficacy endpoint is the change from baseline to Day 43 in the CGI-S score., The proportion of patients who are treatment responders where response is defined as a ≥ 50% decrease from baseline in MADRS total score at Day 43;, The proportion of remitters, where remission is defined as a MADRS total score ≤ 10 at Day 43;, By-visit mean change from baseline in the MADRS total score;, By-visit mean change from baseline in the HAM-A total score;, By-visit mean change from baseline in the CSFQ-14 total score;, By-visit mean change from baseline in CGI-S score;, Change from baseline in MADRS individual item scores at each assessment time point, including Day 43;, Safety parameters (AEs, clinical laboratory, vital signs, ECG, and EPS (AIMS, BARS, and SAS) and C-SSRS scales)

Related papers

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Interventions

DRUGPlacebo capsules (not containing the active substance

DRUGotherwise identical to lumateperone capsules)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from Baseline (Visit 2) to Day 43 (Visit 8) in MADRS total score.	—

Secondary

Measure	Time frame
Key secondary efficacy endpoint is the change from baseline to Day 43 in the CGI-S score., The proportion of patients who are treatment responders where response is defined as a ≥ 50% decrease from baseline in MADRS total score at Day 43;, The proportion of remitters, where remission is defined as a MADRS total score ≤ 10 at Day 43;, By-visit mean change from baseline in the MADRS total score;, By-visit mean change from baseline in the HAM-A total score;, By-visit mean change from baseline in the CSFQ-14 total score;, By-visit mean change from baseline in CGI-S score;, Change from baseline in MADRS individual item scores at each assessment time point, including Day 43;, Safety parameters (AEs, clinical laboratory, vital signs, ECG, and EPS (AIMS, BARS, and SAS) and C-SSRS scales)	—

Measure

Time frame

Key secondary efficacy endpoint is the change from baseline to Day 43 in the CGI-S score., The proportion of patients who are treatment responders where response is defined as a ≥ 50% decrease from baseline in MADRS total score at Day 43;, The proportion of remitters, where remission is defined as a MADRS total score ≤ 10 at Day 43;, By-visit mean change from baseline in the MADRS total score;, By-visit mean change from baseline in the HAM-A total score;, By-visit mean change from baseline in the CSFQ-14 total score;, By-visit mean change from baseline in CGI-S score;, Change from baseline in MADRS individual item scores at each assessment time point, including Day 43;, Safety parameters (AEs, clinical laboratory, vital signs, ECG, and EPS (AIMS, BARS, and SAS) and C-SSRS scales)

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Countries

Bulgaria, France, Lithuania, Spain

Outcome results

None listed