Study of Lurasidone as Adjunctive Treatment in Patients With Major Depressive Disorder With Inadequate Response to Antidepressant Monotherapy

Sponsor
Bukwang Pharmaceutical
Study ID
NCT07781293
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Major Depressive Disorder (MDD)
  • Major Depressive Disorder With Psychotic Features

Eligibility Criteria

Sex
ALL
Age
19 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Lurasidone — DRUG
    Lurasidone
  • Placebo — DRUG
    Placebo
  • Background Antidepressant Therapy — DRUG
    Background Antidepressant treatment (ADT)

Study Details

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).

Key Dates

First listed
Aug 24, 2026
Start date
Sep 28, 2026
Status verified
Aug 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
364 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lurasidone + Antidepressant
  • Placebo Comparator: Placebo + Antidepressant

Primary Outcome Measure

Change From Baseline in Montgomery-Åsberg Depression Rating Scale Total Score at Week 8 [ Time Frame: Baseline to Week 8 ]

Central Contacts

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