This Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the efficacy and safety of lurasidone as adjunctive therapy in adult patients with major depressive disorder (MDD) who show an inadequate response to antidepressant monotherapy. Eligible participants will continue their background antidepressant treatment and be randomized to receive either lurasidone (20, 40, or 60 mg/day) or placebo for 8 weeks. The primary endpoint is the change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 8. Secondary endpoints include response and remission rates, changes in Clinical Global Impression-Severity (CGI-S), 17-item Hamilton Depression Rating Scale (HAM-D17), Hamilton Anxiety Rating Scale (HAM-A), and Sheehan Disability Scale (SDS) scores. Safety assessments will include adverse events, laboratory tests, electrocardiograms (ECGs), vital signs, and suicidality monitoring Columbia-Suicide Severity Rating Scale (C-SSRS).
Signed informed consent prior to participation
Outpatients aged 19-64 years
Diagnosis of Major Depressive Disorder (MDD) per DSM-5 using MINI; psychotic features allowed
Current major depressive episode lasting ≥8 weeks at baseline
Lifetime diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or other psychotic disorders
Diagnosis within past 6 months of panic disorder, generalized anxiety disorder, OCD, PTSD, eating disorder, substance abuse/dependence (except caffeine/nicotine), or clinically significant personality disorder
≥25% reduction in MADRS score between screening and baseline
Significant suicide risk (per C-SSRS, MADRS item 10 ≥5, recent suicide attempt, or investigator judgment)
Parallel
Lurasidone
DrugLurasidone
Placebo
DrugPlacebo
Background Antidepressant Therapy
DrugBackground Antidepressant treatment (ADT)
Change From Baseline in Montgomery-Åsberg Depression Rating Scale Total Score at Week 8
The MADRS is a 10-item clinician-rated scale used to assess the severity of depressive symptoms. Each item is scored from 0 to 6, with a total score ranging from 0 to 60. Higher scores indicate greater severity of depressive symptoms.
Change From Baseline in Montgomery-Åsberg Depression Rating Scale Total Score by Lurasidone Dose (20, 40, or 60 mg)
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician-rated scale used to assess the severity of depressive symptoms. Each item is scored from 0 to 6, resulting in a total score ranging from 0 to 60. Higher scores indicate greater severity of depressive symptoms. Mean change from baseline in MADRS total score at Week 8 will be evaluated for each lurasidone dose group (20, 40, or 60 mg) compared with placebo.
Change in Montgomery-Åsberg Depression Rating Scale Total Score During the Treatment Period by Lurasidone Dose (20, 40, or 60 mg)
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician-rated scale used to assess the severity of depressive symptoms. Each item is scored from 0 to 6, resulting in a total score ranging from 0 to 60. Higher scores indicate greater severity of depressive symptoms. Mean change in MADRS total score during the treatment period will be evaluated for each lurasidone dose group (20, 40, or 60 mg) compared with placebo.
MADRS Response Rate
The Montgomery-Åsberg Depression Rating Scale (MADRS) total score ranges from 0 to 60, with higher scores indicating greater severity of depressive symptoms. Response is defined as a change in MADRS total score from baseline that meets the prespecified criterion of at least a 50% decrease from baseline.
MADRS Remission Rate
Proportion of participants with MADRS total score ≤10 at Week 8
Incidence of Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations due to AE
Frequency and proportion of participants experiencing adverse events, serious adverse events, and discontinuations due to adverse events during the study.
Change From Baseline in Abnormal Involuntary Movement Scale Total Score
The Abnormal Involuntary Movement Scale (AIMS) is a clinician-rated scale used to assess the severity of abnormal involuntary movements. Items assessing abnormal movements are rated from 0 (none) to 4 (severe), with higher scores indicating greater severity of abnormal involuntary movements. Change from baseline in the AIMS total score will be evaluated.
Change From Baseline in Barnes Akathisia Rating Scale Total Score
The Barnes Akathisia Rating Scale (BARS) is a clinician-rated scale used to assess akathisia. The scale includes objective restlessness, subjective awareness of restlessness, subjective distress related to restlessness, and a general clinical assessment of akathisia. Higher scores indicate greater severity of akathisia. Change from baseline in the BARS total score will be evaluated.
Change From Baseline in Simpson-Angus Scale Total Score
The Simpson-Angus Scale (SAS) is a 10-item clinician-rated scale used to assess drug-induced parkinsonian symptoms. Each item is scored from 0 to 4, with higher scores indicating greater severity of parkinsonian symptoms. The total score ranges from 0 to 40. Change from baseline in the SAS total score will be evaluated.
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