Major Depressive Disorder (MDD)Phase 3NCT07781293
Study of Lurasidone as Adjunctive Treatment in Patients With Major Depressive Disorder With Inadequate Response to Antidepressant Monotherapy
A Phase 3 study testing Lurasidone and Background Antidepressant Therapy in people with Major Depressive Disorder (MDD) and Major Depressive Disorder With Psychotic Features, run by Bukwang Pharmaceutical.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 64 years
- Conditions the study is for
- Major Depressive Disorder (MDD), Major Depressive Disorder With Psychotic Features
- What is being tested?
- Lurasidone and Background Antidepressant Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 364 participants
- Where
- No sites listed yet
- Study dates
- 28 Sep 2026to Oct 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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)
- First major depressive episode onset after age 60
- Treatment resistance: ≥3 adequate ADT trials without remission, or non-response to antipsychotic augmentation
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- Prior ECT, VNS, rTMS within 5 years or history of ECT failure
- Known hypersensitivity to lurasidone or excipients
- Use of prohibited medications (strong CYP3A4 inhibitors/inducers, QTc-prolonging drugs) within 14 days before randomization
- Prior exposure to lurasidone or investigational CNS drugs (per protocol limits)
- Pregnancy, breastfeeding, or unwillingness to use effective contraception; positive pregnancy test at screening or baseline
- Clinically significant ECG abnormalities.
- Clinically significant laboratory abnormalities that may affect study participation or safety.
- Clinically significant uncontrolled cardiovascular, hepatic, renal, endocrine, neurological, psychiatric, or other medical conditions that may affect study participation or safety.
- 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
- More than 2 prior attempts at screening/washout for this study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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).
Read the detailed description
Major depressive disorder (MDD) is a common psychiatric condition, and many patients fail to achieve adequate improvement with antidepressant monotherapy. Adjunctive therapies are therefore needed to improve outcomes. Lurasidone, an atypical antipsychotic, has shown potential benefit when combined with antidepressants.
This study will enroll up to 364 adult outpatients aged 19-64 years who meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD and demonstrate inadequate response to at least one antidepressant. Participants must have a MADRS score ≥24 and CGI-S score ≥4 at both screening and baseline. After a screening/washout period of up to 14 days, subjects will be randomized 1:1 to lurasidone or placebo, in addition to their ongoing antidepressant.
Treatment period: 8 weeks of double-blind therapy, with dose titration allowed in the first 2 weeks and fixed dosing thereafter.
Follow-up: 1 week safety follow-up after last dose.
Primary objective: To assess whether adjunctive lurasidone significantly improves depressive symptoms compared to placebo, measured by MADRS total score change from baseline to Week 8.
Secondary objectives: To evaluate response and remission rates, functional improvement (SDS), and changes in anxiety and depression severity scales (HAM-A, HAM-D17, CGI-S).
Safety objectives: To monitor adverse events, extrapyramidal symptoms (Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), Simpson-Angus Scale (SAS)), suicidality (Columbia-Suicide Severity Rating Scale (C-SSRS)), laboratory values, electrocardiograms (ECGs), and vital signs.
This trial will provide important evidence on the role of lurasidone as adjunctive therapy for patients with MDD who do not respond adequately to antidepressant monotherapy.
- Being tested
- Lurasidone, Placebo, Background Antidepressant Therapy
- Keywords
- Major Depressive Disorder, Antidepressant Inadequate Response, Adjunctive Therapy, Randomized Double-Blind Placebo-Controlled
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LurasidoneDrug
Lurasidone
PlaceboDrug
Placebo
Background Antidepressant TherapyDrug
Background Antidepressant treatment (ADT)
| Study group | Role | What they receive |
|---|---|---|
| Lurasidone + Antidepressant | Experimental | Not described Receives: Drug: Lurasidone; Drug: Background Antidepressant Therapy |
| Placebo + Antidepressant | Placebo comparator | Not described Receives: Drug: Placebo; Drug: Background Antidepressant Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 8
Secondary outcomes (8)
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.
Measured: Baseline to Week 8
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.
Measured: dose-specific baseline to Week 8
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.
Measured: Baseline to Week 8
MADRS Remission Rate
Proportion of participants with MADRS total score ≤10 at Week 8
Measured: Baseline to Week 8
Change From Baseline in Clinical Global Impression-Severity Score
Change from baseline in CGI-S score at Week 8.
Measured: Baseline to Week 8
Change From Baseline in Hamilton Anxiety Rating Scale Score
Change from baseline in HAM-A score at Week 8.
Measured: Baseline to Week 8
Change From Baseline in 17-Item Hamilton Depression Rating Scale Score
Change from baseline in HAM-D17 score at Week 8.
Measured: Baseline to Week 8
Change From Baseline in Sheehan Disability Scale Total and Subscale Scores
Ｃhange from baseline in SDS total and subscale score at Week 8.
Measured: Baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start28 Sep 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to receive adjunctive lurasidone (20, 40, or 60 mg/day) or placebo, in addition to ongoing antidepressant therapy, for 8 weeks.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 364 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bukwang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781293
- Sponsor's protocol ID
- BK-LUD-302
- Other IDs
- BK-LUD-302
- Status last verified
- Sep 2026
- First submitted
- 6 Aug 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07781293
- Acronym / sponsor ID
- BK-LUD-302
- Keywords
- Major Depressive Disorder, Antidepressant Inadequate Response, Adjunctive Therapy, Randomized Double-Blind Placebo-Controlled
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 364 participants (estimated)
- Lead sponsor
- Bukwang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Major depressive disorder (MDD) is a common psychiatric condition, and many patients fail to achieve adequate improvement with antidepressant monotherapy. Adjunctive therapies are therefore needed to improve outcomes. Lurasidone, an atypical antipsychotic, has shown potential benefit when combined with antidepressants.
This study will enroll up to 364 adult outpatients aged 19-64 years who meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD and demonstrate inadequate response to at least one antidepressant. Participants must have a MADRS score ≥24 and CGI-S score ≥4 at both screening and baseline. After a screening/washout period of up to 14 days, subjects will be randomized 1:1 to lurasidone or placebo, in addition to their ongoing antidepressant.
Treatment period: 8 weeks of double-blind therapy, with dose titration allowed in the first 2 weeks and fixed dosing thereafter.
Follow-up: 1 week safety follow-up after last dose.
Primary objective: To assess whether adjunctive lurasidone significantly improves depressive symptoms compared to placebo, measured by MADRS total score change from baseline to Week 8.
Secondary objectives: To evaluate response and remission rates, functional improvement (SDS), and changes in anxiety and depression severity scales (HAM-A, HAM-D17, CGI-S).
Safety objectives: To monitor adverse events, extrapyramidal symptoms (Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), Simpson-Angus Scale (SAS)), suicidality (Columbia-Suicide Severity Rating Scale (C-SSRS)), laboratory values, electrocardiograms (ECGs), and vital signs.
This trial will provide important evidence on the role of lurasidone as adjunctive therapy for patients with MDD who do not respond adequately to antidepressant monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to receive adjunctive lurasidone (20, 40, or 60 mg/day) or placebo, in addition to ongoing antidepressant therapy, for 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Lurasidone + Antidepressant | Experimental | Drug: Lurasidone, Drug: Background Antidepressant Therapy |
| Placebo + Antidepressant | Placebo comparator | Drug: Placebo, Drug: Background Antidepressant Therapy |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (18 listed)
- 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)
- First major depressive episode onset after age 60
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LurasidoneLurasidone | Drug | Lurasidone + Antidepressant |
| PlaceboPlacebo | Drug | Placebo + Antidepressant |
| Background Antidepressant TherapyBackground Antidepressant treatment (ADT) | Drug | Lurasidone + Antidepressant, Placebo + Antidepressant |
Primary outcome
Change From Baseline in Montgomery-Åsberg Depression Rating Scale Total Score at Week 8
Time frame: Baseline to 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.
8 secondary outcomes
Change From Baseline in Montgomery-Åsberg Depression Rating Scale Total Score by Lurasidone Dose (20, 40, or 60 mg)
Time frame: Baseline to Week 8
Change in Montgomery-Åsberg Depression Rating Scale Total Score During the Treatment Period by Lurasidone Dose (20, 40, or 60 mg)
Time frame: dose-specific baseline to Week 8
MADRS Response Rate
Time frame: Baseline to Week 8
MADRS Remission Rate
Time frame: Baseline to Week 8
Change From Baseline in Clinical Global Impression-Severity Score
Time frame: Baseline to Week 8
Change From Baseline in Hamilton Anxiety Rating Scale Score
Time frame: Baseline to Week 8
Change From Baseline in 17-Item Hamilton Depression Rating Scale Score
Time frame: Baseline to Week 8
Change From Baseline in Sheehan Disability Scale Total and Subscale Scores
Time frame: Baseline to Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Nedrug(MFDS)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lurasidone and Background Antidepressant Therapy in people with Major Depressive Disorder (MDD) and Major Depressive Disorder With Psychotic Features, run by Bukwang Pharmaceutical.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hyunjeong Kim (+82-2-828-8088, hyun.jeong.kim@bukwang.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Montgomery-Åsberg Depression Rating Scale Total Score at Week 8 (time frame: Baseline to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.