A Phase 3 interventional study of Lurasidone and Placebo in Major Depressive Disorder (MDD) and Major Depressive Disorder With Psychotic Features, sponsored by Bukwang Pharmaceutical. Not yet recruiting. Open to participants aged 19 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Bukwang Pharmaceutical · Phase 3, Interventional, and Treatment
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).
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.
3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.
This study's planned enrollment of 364 is above the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →Bukwang Pharmaceutical is the lead sponsor of 34 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Lurasidone · Drug: Background Antidepressant Therapy
Drug: Placebo · Drug: Background Antidepressant Therapy
Lurasidone
Placebo
Background 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.
Time frame: Baseline to Week 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.
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)
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.
Time frame: 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.
Time frame: Baseline to Week 8
MADRS Remission Rate
Proportion of participants with MADRS total score ≤10 at Week 8
Time frame: Baseline to Week 8
Change From Baseline in Clinical Global Impression-Severity Score
Change from baseline in CGI-S score at Week 8.
Time frame: Baseline to Week 8
Change From Baseline in Hamilton Anxiety Rating Scale Score
Change from baseline in HAM-A score at Week 8.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 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.
Time frame: Baseline ~ Week8 + 1week Safety Follow-up
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.
Time frame: Baseline ~ Week8 + 1week Safety Follow-up
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.
Time frame: Baseline ~ Week8 + 1week Safety Follow-up
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.
Time frame: Baseline ~ Week8 + 1week Safety Follow-up
Suicidal Ideation and Suicidal Behavior Assessed by the Columbia-Suicide Severity Rating Scale
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinician-administered assessment used to identify and classify suicidal ideation and suicidal behavior. This outcome measure does not report a single C-SSRS total score. The frequency and percentage of participants with protocol-specified categories of suicidal ideation and suicidal behavior will be summarized.
Time frame: Baseline ~ Week8 + 1week Safety Follow-up
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Lurasidone