Major Depressive DisorderPhase 3NCT05850689
Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
A Phase 3 study testing Lumateperone in people with Major Depressive Disorder, run by Intra-Cellular Therapies, Inc. at 69 sites in 7 countries.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an inadequate response to ongoing ADT. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Lumateperone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 470 participants
- Where
- 69 sitesin 7 countries
- Study dates
- 2 May 2023to 5 Apr 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients between the ages of 18 and 65 years, inclusive;
- Meets DSM-5 criteria for MDD (MDD with psychotic features will be acceptable) as confirmed by the Investigator or Sponsor-approved rater using the modified Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT) and meets all of the following criteria:
- The start of the current major depressive episode (MDE) is at least 12 weeks but not more than 18 months prior to Screening;
- Has at least moderate severity of illness based on rater-administered MADRS total score ≥ 24 at Screening and at Baseline;
- Has at least moderate severity of illness based on CGI-S score ≥ 4 at Screening and at Baseline;
- Has a Quick Inventory of Depressive Symptomatology-Self Report-16 item (QIDS-SR-16) score ≥ 14 at Screening and at Baseline;
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- Has sufficient history and medical record confirmation verifying the ADT and the current MDE is causing clinically significant distress or impairment in social, occupational, or other important areas of functioning.
- Currently having an inadequate response (less than 50% improvement) to 2 or more ADTs in the current MDE as confirmed by the Investigator using the Antidepressant Treatment Response Questionnaire (ATRQ) and taking at least the minimum effective dose (per package insert) of one of the following antidepressants as monotherapy treatment for at least 6 weeks duration:
- citalopram/escitalopram
- fluoxetine
- paroxetine
- sertraline
- duloxetine
- levomilnacipran/milnacipran (if locally approved for MDD)
- venlafaxine/desvenlafaxine
- bupropion
- vilazodone
- vortioxetine
Who cannot join
- Within the patient's lifetime, has a confirmed DSM-5 psychiatric diagnosis other than MDD, including:
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder;
- Bipolar Disorder;
- Within 6 months of Screening, has a confirmed DSM-5 psychiatric diagnosis other than MDD including:
- Anxiety disorders such as Panic Disorder or Generalized Anxiety Disorder; Obsessive-compulsive Disorder; Posttraumatic Stress Disorder as primary diagnoses. Note: Anxiety symptoms may be allowed if secondary to MDD, provided these symptoms do not require concurrent treatment;
- Eating disorder;
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- Substance use disorders (excluding nicotine);
- Personality disorder of sufficient severity to have a major impact on the patient's psychiatric status;
- Within 12 months of Screening, has had any other psychiatric condition (other than MDD) that has been the main focus of treatment;
- The patient experiences a ≥ 25% decrease in the MADRS total score between Screening and Baseline;
- The patient experiences a ≥ 25% decrease in the QIDS-SR-16 total score between Screening and Baseline;
- In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during participation in the study or:
- At Screening, the patient scores "yes" on Suicidal Ideation Items 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening, or at Baseline, the patient scores "yes" on Suicidal Ideation Items 4 or 5 since the Screening Visit;
- At Screening, the patient has had 1 or more suicide attempts within 2 years prior to Screening;
- At Screening or Baseline, the patient scores ≥ 5 on MADRS Item 10 (Suicidal Thoughts), or
- The patient is considered to be in imminent danger to him/herself or others.
- The patient has a first MDE at age 60 years or older.
Trial locations and contacts
69 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
69 sites in 7 countries
United States25 sites, 20 recruiting
- Recruiting
The Emory Clinic
Atlanta, Georgia, 30329
- Recruiting
Quest Therapeutics of Avon Lake
Avon Lake, Ohio, 44012
- Recruiting
Northwest Clinical Research Center
Bellevue, Washington, 98007
- Recruiting
SPRI Clinical Trials, LLC
Brooklyn, New York, 11235
- Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
- Terminated
Vertex Clinical Research
Clermont, Florida, 34711
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
- Recruiting
CenExeli Research LLC
Decatur, Georgia, 30030
- Recruiting
University of Connecticut Health Center
Farmington, Connecticut, 06030
- Suspended
New Life Medical Research Center, Inc.
Hialeah, Florida, 33012
- Recruiting
DM Clinical Research
Houston, Texas, 77081
- Recruiting
University of Alabama at Birmingham
Huntsville, Alabama, 35801
- Terminated
University of Kansas Medical Center Research Institute
Kansas City, Kansas, 66160
- Completed
Hawkins Psychiatry, PC
Mansfield, Texas, 76063
- Terminated
ActivMed Practices and Research
Methuen, Massachusetts, 01844
- Recruiting
Premier Clinical Research Institute
Miami, Florida, 33122
- Recruiting
Miami Jewish Health System
Miami, Florida, 33137
- Recruiting
Manhattan Behavioral Medicine
New York, New York, 10036
- Recruiting
Psychiatric Care and Research Center (PCRC)
O'Fallon, Missouri, 63368
- Recruiting
Collective Medical Research
Overland Park, Kansas, 66210
- Recruiting
University of Pennsylvania - Perelman School of Medicine
Philadelphia, Pennsylvania, 19104
- Recruiting
CNRI-Los Angeles, LLC
Pico Rivera, California, 90660
- Recruiting
Pillar Clinical Research, LLC
Richardson, Texas, 75080
- Recruiting
Interventional Psychiatry of Tampa Bay
Tampa, Florida, 33629
- Recruiting
Bio Behavioral Health
Toms River, New Jersey, 08755
India13 sites, 7 recruiting
- Suspended
Ratandeep Surgical Hospital And Endoscopy Clinic
Ahmedabad, 380008
- Suspended
Sushrusha Navneet Memorial Hospital
Ahmedabad, 380009
- Suspended
J L N Medical College and Attached Hospitals
Ajmer, 305001
- Recruiting
Baramati Hospital
Bārāmati, 413102
- Recruiting
S P Medical College And Associated Group of Hospitals
Bikaner, 334001
- Recruiting
Post Graduate Institute of Medical Education And Research PGIMER
Chandigarh, 160012
- Completed
Gauhati Medical College and Hospital
Guwahati, 781032
- Recruiting
Swastik Hospital
Kolhāpur, 416001
- Recruiting
KIMS-Kingsway Hospitals
Nagpur, 440001
- Recruiting
Divyam Hospital
Palsāna, 394315
- Recruiting
Shree Samarth Hospital
Pune, 411011
- Completed
Nagecha Hospital
Rajkot, 360001
- Suspended
Acharya vinoba bhave rural hospital
Wardha, 442004
Bulgaria10 sites, 8 recruiting
- Recruiting
Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ET
Cherven Bryag, 5980
- Recruiting
Medical Center Lifemed
Kardzhali, 6600
- Recruiting
Medical Center Medconsult-Pleven
Pleven, 5800
- Recruiting
Medical Center Mentalcare OOD
Plovdiv, 4004
- Recruiting
MHC - Sofia, EOOD
Sofia, 1202
- Terminated
University Multiprofile Hospital for Active Treatment - UMHAT Alexandrovska EAD
Sofia, 1431
- Recruiting
Medical Center Hera EOOD
Sofia, 1510
- Recruiting
Medical Center Intermedica, OOD
Sofia, 1680
- Completed
UMHAT Prof. Dr. St. Kirkovich AD
Stara Zagora, 6003
- Recruiting
Diagnostic Consulting Center Mladost - M Varna
Varna, 9020
Serbia9 sites, 9 recruiting
- Recruiting
Clinical Center Dr Dragisa Misovic Dedinje
Belgrade, 11000
- Recruiting
Institute of Mental Health Serbia
Belgrade, 11000
- Recruiting
University Clinical Center of Serbia
Belgrade, 11000
- Recruiting
Special Hospital for Psychiatric Diseases Kovin
Kovin, 26220
- Recruiting
University Clinical Center Kragujevac 1
Kragujevac, 34000
- Recruiting
University Clinical Center Kragujevac
Kragujevac, 34000
- Recruiting
University Clinical Center NIS 1
Niš, 18000
- Recruiting
University Clinical Center NIS
Niš, 18000
- Recruiting
Special Hospital for Psychiatric Diseases Sveti Vracevi
Novi Kneževac, 23330
France5 sites, 5 recruiting
- Recruiting
Cabinet Medical des Drs Prizac-Desbonnet Scottez
Douai, 59500
- Recruiting
CHU de Nantes hotel Dieu
Nantes, 44093
- Recruiting
Hopital Caremeau
Nîmes, 30029
- Recruiting
Groupe Hospitalier Pitie-Salpetriere
Paris, 75012
- Recruiting
CH Henri Laborit
Poitiers, 86021
Spain5 sites, 4 recruiting
- Recruiting
Hosp Univ Vall D Hebron
Barcelona, 08035
- Recruiting
Hosp. Clinic de Barcelona
Barcelona, 08036
- Completed
Hosp. Univ. Ramon Y Cajal
Madrid, 28034
- Recruiting
Hosp.Univ.Parc Tauli
Sabadell, 08208
- Recruiting
Hosp. Prov. de Zamora
Zamora, 49021
Lithuania2 sites
- Completed
Romuvos Klinika, JSC
Kaunas, LT-44279
- Completed
Kaunas Hospital of Lithuanian University of Health Sciences Psychiatric Clinic Mariu division
Ziegzdriai, 53136
About this study
Official title: A Randomized, Double-Blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
This is a multicenter, randomized, double-blind, placebo-controlled parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an inadequate response to ongoing ADT.
Read the detailed description
The study will be conducted in three periods:
- Screening Period (up to 2 weeks) during which patient eligibility will be assessed.
- Double-blind Treatment Period (6 weeks) in which all patients will be randomized to receive placebo or lumateperone 42 mg/day in 1:1 ratio.
- Safety Follow-up Period (1 week) in which all patients will return to the clinic for a safety follow-up visit approximately one week after the last dose of study treatment.
- Conditions
- Major Depressive Disorder
- Being tested
- Lumateperone, Placebo
- Keywords
- Adjunctive MDD Therapy
- 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.
LumateperoneDrug
Lumateperone 42 mg capsules administered orally, once daily
PlaceboDrug
Matching capsules administered orally, once daily
| Study group | Role | What they receive |
|---|---|---|
| Lumateperone 42 mg | Experimental | Not described Receives: Drug: Lumateperone |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg Depression Rating Scale
The MADRS is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms.
Measured: Day 43
Secondary outcomes (1)
Clinical Global Impression Scale-Severity
The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Measured: Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start2 May 2023
- Primary completion5 Apr 2027 (estimated)
- Study completion5 Apr 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 DisorderStudies of the same condition, open and under way.
- More trials run by Intra-Cellular Therapies, Inc.The sponsor's other registered studies.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 470 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intra-Cellular Therapies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Intra-Cellular Therapies, Inc. Clinical Trial, Study director, Intra-Cellular Therapies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850689
- Sponsor's protocol ID
- ITI-007-505
- Other IDs
- ITI-007-505
- Status last verified
- Nov 2026
- First submitted
- 28 Apr 2023
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT05850689
- Acronym / sponsor ID
- ITI-007-505
- Conditions
- Major Depressive Disorder
- Keywords
- Adjunctive MDD Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 470 participants (estimated)
- Lead sponsor
- Intra-Cellular Therapies, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 May 2023 (actual)
- Primary completion
- 5 Apr 2027 (estimated)
- Study completion
- 5 Apr 2027 (estimated)
- First posted
- 9 May 2023 (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 is a multicenter, randomized, double-blind, placebo-controlled parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an inadequate response to ongoing ADT.
Detailed description
The study will be conducted in three periods:
- Screening Period (up to 2 weeks) during which patient eligibility will be assessed.
- Double-blind Treatment Period (6 weeks) in which all patients will be randomized to receive placebo or lumateperone 42 mg/day in 1:1 ratio.
- Safety Follow-up Period (1 week) in which all patients will return to the clinic for a safety follow-up visit approximately one week after the last dose of study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumateperone 42 mg | Experimental | Drug: Lumateperone |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Male or female patients between the ages of 18 and 65 years, inclusive;
- Meets DSM-5 criteria for MDD (MDD with psychotic features will be acceptable) as confirmed by the Investigator or Sponsor-approved rater using the modified Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT) and meets all of the following criteria:
- Currently having an inadequate response (less than 50% improvement) to 2 or more ADTs in the current MDE as confirmed by the Investigator using the Antidepressant Treatment Response Questionnaire (ATRQ) and taking at least the minimum effective dose (per package insert) of one of the following antidepressants as monotherapy treatment for at least 6 weeks duration:
Key exclusion criteria (17 listed)
- Within the patient's lifetime, has a confirmed DSM-5 psychiatric diagnosis other than MDD, including:
- Within 6 months of Screening, has a confirmed DSM-5 psychiatric diagnosis other than MDD including:
- The patient experiences a ≥ 25% decrease in the MADRS total score between Screening and Baseline;
- The patient experiences a ≥ 25% decrease in the QIDS-SR-16 total score between Screening and Baseline;
- In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during participation in the study or:
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 |
|---|---|---|
| LumateperoneLumateperone 42 mg capsules administered orally, once daily | Drug | Lumateperone 42 mg |
| PlaceboMatching capsules administered orally, once daily | Drug | Placebo |
Primary outcome
Montgomery-Asberg Depression Rating Scale
Time frame: Day 43
The MADRS is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms.
1 secondary outcome
Clinical Global Impression Scale-Severity
Time frame: Day 43
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 3 Nov 2026.
- 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.
Intra-Cellular Therapies, Inc. Clinical Trial study director
Intra-Cellular Therapies, Inc.
69 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lumateperone in people with Major Depressive Disorder, run by Intra-Cellular Therapies, Inc. at 69 sites in 7 countries.
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 18 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in United States, India, Bulgaria, Serbia, France and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Asberg Depression Rating Scale (time frame: Day 43). 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 3 Nov 2026.