NCT07781293Not yet recruitingPhase 3
Study of Lurasidone as Adjunctive Treatment in Patients With Major Depressive Disorder With Inadequate Response to Antidepressant Monotherapy
Evaluating the Efficacy and Safety of Lurasidone as Adjunctive Therapy in Adult Patients Diagnosed With Major Depressive Disorder Who Have an Inadequate Response to Antidepressant Monotherapy: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 364 (estimated)
- First submitted
- 6 Aug 2026
- Start date
- 28 Sept 2026
- Primary completion date
- Oct 2027
- Lead sponsor
- Bukwang Pharmaceutical
- Diseases
- Depression
- NCT number
- NCT07781293
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 364
- From 28 Sept 2026 to the primary completion date, Oct 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior ECT, VNS, rTMS within 5 years or history of ECT failure
- Prior exposure to lurasidone or investigational CNS drugs (per protocol limits)
- More than 2 prior attempts at screening/washout for this study
Other illness
- 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
- Known hypersensitivity to lurasidone or excipients
- Clinically significant uncontrolled cardiovascular, hepatic, renal, endocrine, neurological, psychiatric, or other medical conditions that may affect study participation or safety.
Lab values
- Use of prohibited medications (strong CYP3A4 inhibitors/inducers, QTc-prolonging drugs) within 14 days before randomization
- Clinically significant laboratory abnormalities that may affect study participation or safety.
Age
- First major depressive episode onset after age 60
Other
- ≥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)
- Treatment resistance: ≥3 adequate ADT trials without remission, or non-response to antipsychotic augmentation
- Pregnancy, breastfeeding, or unwillingness to use effective contraception; positive pregnancy test at screening or baseline
- Clinically significant ECG abnormalities.
- Prolactin \>100 ng/mL or pituitary adenoma history
- Investigator/site staff or family members of study personnel
- Inability to comply with study procedures or anticipated relocation during study
Who the study is looking for
- 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
- MADRS total score ≥24 at both screening and baseline
- CGI-S score ≥4 at both screening and baseline
- Documented history of antidepressant treatment (ADT) with inadequate response (\<50% improvement)
- Currently on one of the protocol-permitted antidepressants at minimum effective dose for ≥6 weeks
- Agreement to maintain the same background ADT regimen until study completion
- BMI between 16-40 kg/m²
- Willingness to discontinue prohibited psychotropic medications during washout
- Stable doses of permitted concomitant medications (oral hypoglycemics ≥30 days, thyroid replacement ≥90 days, antihypertensives ≥30 days, lipid-lowering agents ≥30 days before baseline)
Age in the registry: 19 years to 64 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.