Major Depressive DisorderPhase 3NCT05061719
An Open-label 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 109 sites in 11 countries.
Trial summary
This is a multicenter, open-label, fixed dose, 26 week study of patients with MDD. Eligible patients from the lead-in studies will enter the Open-label Safety Study at the Screening/Baseline Visit (Visit 1/Day 1), at which point patient eligibility will be assessed and informed consent obtained. 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?
- No, everyone receives an active treatment
- How many people
- 812 participants
- Where
- 109 sitesin 11 countries
- Study dates
- 8 Oct 2021to 23 Oct 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- In the opinion of the Investigator, patients must have safely completed the lead-in study.
- Patient is taking their ADT as prescribed from the lead-in study.
Who cannot join
- In the opinion of the Investigator, the patient is unable to comply with study procedures or judged to be inappropriate for the study.
- In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during the course of her/his participation in the study or is considered to be an imminent danger to her/himself or others, and/or:
- At the Screening/Baseline Visit, the patient scores "yes" on Suicidal Ideation Items 4 or 5 of the C SSRS "Since Last Visit" version;
- At the Screening/Baseline visit, the patient scores ≥ 5 on the MADRS Item 10 (Suicidal Thoughts).
- Based on the Investigator's clinical judgement, any abnormal clinical laboratory test or ECG results obtained throughout the lead-in study that are considered clinically significant and preclude safe participation in the study.
Trial locations and contacts
109 sites in 11 countries.
109 sites in 11 countries
United States40 sites
Clinical Site
Allentown, Pennsylvania, 18104
Clinical Site
Atlanta, Georgia, 30328
Clinical Site
Atlanta, Georgia, 30329
Clinical Site
Atlanta, Georgia, 30331
Clinical Site
Austin, Texas, 78737
Clinical Site
Bellevue, Washington, 98007
Clinical Site
Bentonville, Arkansas, 72712
Clinical Site
Berlin, New Jersey, 08009
Clinical Site
Boston, Massachusetts, 02131
Clinical Site
Brooklyn, New York, 11235
Clinical Site
Cedarhurst, New York, 11516
Clinical Site
Charlotte, North Carolina, 28211
Clinical Site
Culver City, California, 90230
Clinical Site
Decatur, Georgia, 30030
Clinical Site
Flowood, Mississippi, 39232
Clinical Site
Fort Lauderdale, Florida, 33319
Clinical Site
Gaithersburg, Maryland, 20877
Clinical Site
Glendale, California, 91206
Clinical Site
Jacksonville, Florida, 32256
Clinical Site
Joliet, Illinois, 60435
Clinical Site
Little Rock, Arkansas, 72211
Clinical Site
Media, Pennsylvania, 19063
Clinical Site
Mount Kisco, New York, 10549
Clinical Site
Newport Beach, California, 92660
Clinical Site
Oceanside, California, 92056
Clinical Site
Orlando, Florida, 32801
Clinical Site
Overland Park, Kansas, 66211
Clinical Site
Palm Bay, Florida, 32905
Clinical Site
Phoenix, Arizona, 85012
Clinical Site
Plymouth Meeting, Pennsylvania, 19462
Clinical Site
Redlands, California, 92374
Clinical Site
Riverside, California, 92506
Clinical Site
Rogers, Arkansas, 72758
Clinical Site
Saint Charles, Missouri, 63304
Clinical Site
San Diego, California, 92103
Clinical Site
Sherman Oaks, California, 91403
Clinical Site
Temecula, California, 92951
Clinical Site
Toms River, New Jersey, 08755
Clinical Site
Upland, California, 91786
Clinical Site
West Palm Beach, Florida, 33407
Bulgaria13 sites
Clinical Site
Burgas, 8001
Clinical Site
Kazanlak, 6100
Clinical Site
Novi Iskar, 1282
Clinical Site
Pleven, 5809
Clinical Site
Plovdiv, 4004
Clinical Site
Rousse, 7003
Clinical Site
Sofia, 1408
Clinical Site
Sofia, 1680
Clinical Site
Targovishte, 7700
Clinical Site
Tsarev Brod, 9747
Clinical Site
Veliko Tarnovo, 5000
Clinical Site
Veliko Tarnovo, 5047
Clinical Site
Vratsa, 3001
Poland11 sites
Clinical Site
Bełchatów, 97-400
Clinical Site
Bialystok, 15-404
Clinical Site
Bialystok, 15-464
Clinical Site
Bialystok, 15-879
Clinical Site
Bydgoszcz, 85-080
Clinical Site
Gdansk, 80-546
Clinical Site
Gorlice, 38-300
Clinical Site
Leszno, 64-100
Clinical Site
Pruszcz Gdański, 83-000
Clinical SIte
Torun, 87-100
Clinical Site
Wroclaw, 50-414
India10 sites
Clinical Site
Ahmedabad, Gujarat, 380013
Clinical Site
Chhatrapati Sambhajinagar, Maharashtra, 431005
Clinical Site
Guwahati, Assam, 781010
Clinical Site
Jūnāgadh, Gujarat, 362001
Clinical Site
Mumbai, 400008
Clinical Site
Mysore, Karnataka, 570001
Clinical Site
Nagpur, Maharashtra, 440010
Clinical Site
Nashik, Maharashtra, 422001
Clinical Site
Nashik, 422005
Clinical Site
Vadodara, Gujarat, 390021
Czechia8 sites
Clinical Site
Brno, 60200
Clinical site
Brno, 615 00
Clinical Site
Hostivice, 253 01
Clinical Site
Ostrava, 708 00
Clinical Site
Pilsen, 301 00
Clinical Site
Prague, 100 00
Clinical Site
Prague, 160 00
Clinical Site
Prague, 186 00
Germany6 sites
Clinical Site
Bad Homburg, 61348
Clinical Site
Freiburg im Breisgau, 79104
Clinical Site
Hamburg, 20253
Clinical Site
Mittweida, 09648
Clinical Site
Schwerin, 19053
Clinical Site
Westerstede, 26655
Hungary6 sites
Clinical Site
Budapest, 1033
Clinical Site
Budapest, 1083
Clinical Site
Budapest, 1134
Clinical Site
Budapest, 1135
Clinical Site
Debrecen, 4032
Clinical Site
Gyöngyös, 3200
Slovakia6 sites
Clinical Site
Bratislava, 82007
Clinical Site
Košice, 04001
Clinical Site
Rimavská Sobota, 979 01
Clinical Site
Svidník, 089 01
Clinical Site
Vranov nad Topľou, 09301
Clinical Site
Zlaté Moravce, 953 01
South Korea5 sites
Clinical Site
Ansan-si, North Chungcheong, 15355
Clinical Site
Gwangju, 61469
Clinical Site
Seoul, 01830
Clinical Site
Seoul, 03080
Clinical Site
Seoul, 06351
About this study
Official title: An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
This is a multicenter, open-label, fixed dose, 26 week study of patients with MDD. Eligible patients from the lead-in studies will enter the Open-label Safety Study at the Screening/Baseline Visit (Visit 1/Day 1), at which point patient eligibility will be assessed and informed consent obtained.
Read the detailed description
At the Screening/Baseline Visit (Visit 1/Day 1), which is the same visit as Visit 8/Day 43 of the lead-in study, eligible patients will receive open-label lumateperone 42 mg once daily for approximately 26 weeks. Patients will continue their background ADT from the lead-in study. Patients will be seen for weekly visits through Visit 5/Week 4. Thereafter, visits will occur every two weeks. A Safety Follow-up visit will occur on Visit 17/Day 197, approximately 2 weeks after the last dose of open-label lumateperone 42 mg.
- Conditions
- Major Depressive Disorder
- Being tested
- Lumateperone
- 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
| Study group | Role | What they receive |
|---|---|---|
| Lumateperone 42 mg | Experimental | Not described Receives: Drug: Lumateperone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number and Percentage of Patients Reporting Treatment Emergent Adverse Events
An AE that occurs during the Open-label Treatment Period will be considered a treatment-emergent AE (TEAE) if it was not present before the date of the first dose of open-label lumateperone or was present before the date of the first dose of open-label lumateperone but changed in severity during the Open-label Treatment Period.
Measured: 26 weeks
Secondary outcomes (2)
Change From Baseline in One of the 6 Week Double-blind Lead-in Studies (NCT04985942 & NCT05061706) to the End of the Open-Label Treatment Period (a Combined Total of up to 32 Weeks) in the Montgomery-Åsberg 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: 32 weeks
Change From Baseline in One of the 6 Week Double-blind Lead-in Studies (NCT04985942 & NCT05061706) to the End of the Open-Label Treatment Period (a Combined Total of up to 32 Weeks) in the 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 ta all ill) to 7 (among the most extremely ill patients).
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start8 Oct 2021
- Primary completion14 Oct 2024
- Study completion23 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 812 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intra-Cellular Therapies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061719
- Sponsor's protocol ID
- ITI-007-503
- Status last verified
- Oct 2025
- First submitted
- 20 Sep 2021
- Last updated
- 3 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT05061719
- Acronym / sponsor ID
- ITI-007-503
- Conditions
- Major Depressive Disorder
- Keywords
- Adjunctive MDD Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 812 participants (actual)
- Lead sponsor
- Intra-Cellular Therapies, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Oct 2021 (actual)
- Primary completion
- 14 Oct 2024 (actual)
- Study completion
- 23 Oct 2024 (actual)
- First posted
- 29 Sep 2021 (actual)
- Results
- Posted 3 Nov 2025
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, open-label, fixed dose, 26 week study of patients with MDD. Eligible patients from the lead-in studies will enter the Open-label Safety Study at the Screening/Baseline Visit (Visit 1/Day 1), at which point patient eligibility will be assessed and informed consent obtained.
Detailed description
At the Screening/Baseline Visit (Visit 1/Day 1), which is the same visit as Visit 8/Day 43 of the lead-in study, eligible patients will receive open-label lumateperone 42 mg once daily for approximately 26 weeks. Patients will continue their background ADT from the lead-in study. Patients will be seen for weekly visits through Visit 5/Week 4. Thereafter, visits will occur every two weeks. A Safety Follow-up visit will occur on Visit 17/Day 197, approximately 2 weeks after the last dose of open-label lumateperone 42 mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumateperone 42 mg | Experimental | Drug: Lumateperone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- In the opinion of the Investigator, patients must have safely completed the lead-in study.
- Patient is taking their ADT as prescribed from the lead-in study.
Key exclusion criteria (5 listed)
- In the opinion of the Investigator, the patient is unable to comply with study procedures or judged to be inappropriate for the study.
- In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during the course of her/his participation in the study or is considered to be an imminent danger to her/himself or others, and/or:
- Based on the Investigator's clinical judgement, any abnormal clinical laboratory test or ECG results obtained throughout the lead-in study that are considered clinically significant and preclude safe participation in the study.
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 |
Primary outcome
The Number and Percentage of Patients Reporting Treatment Emergent Adverse Events
Time frame: 26 weeks
An AE that occurs during the Open-label Treatment Period will be considered a treatment-emergent AE (TEAE) if it was not present before the date of the first dose of open-label lumateperone or was present before the date of the first dose of open-label lumateperone but changed in severity during the Open-label Treatment Period.
2 secondary outcomes
Change From Baseline in One of the 6 Week Double-blind Lead-in Studies (NCT04985942 & NCT05061706) to the End of the Open-Label Treatment Period (a Combined Total of up to 32 Weeks) in the Montgomery-Åsberg Depression Rating Scale
Time frame: 32 weeks
Change From Baseline in One of the 6 Week Double-blind Lead-in Studies (NCT04985942 & NCT05061706) to the End of the Open-Label Treatment Period (a Combined Total of up to 32 Weeks) in the Clinical Global Impression Scale-Severity
Time frame: 32 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
109 sites in 11 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 109 sites in 11 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 3 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 109 sites in United States, Bulgaria, Poland, India, Czechia and 6 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. 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?
Yes. Results are posted in the registry (first posted 3 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number and Percentage of Patients Reporting Treatment Emergent Adverse Events (time frame: 26 weeks). 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 2025.