Major Depressive DisorderPhase 3NCT05061706
Multicenter 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 50 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
- 480 participants
- Where
- 50 sitesin 7 countries
- Study dates
- 30 Sep 2021to 12 Apr 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
- 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 MINI and meets all of the following criteria:
- The start of the current major depressive episode (MDE) is at least 8 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 (Visit 1) 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 to ADT (less than 50% improvement) as confirmed by the Investigator 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.
- 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
50 sites in 7 countries.
50 sites in 7 countries
United States17 sites
Clinical Site
Allentown, Pennsylvania, 18104
Clinical Site
Atlanta, Georgia, 30329
Clinical Site
Bellevue, Washington, 98007
Clinical Site
Brooklyn, New York, 11235
Clinical Site
Charlotte, North Carolina, 28211
Clinical Site
Flowood, Mississippi, 39232
Clinical Site
Gaithersburg, Maryland, 20877
Clinical Site
Little Rock, Arkansas, 72211
Clinical Site
Media, Pennsylvania, 19063
Clinical Site
Newport Beach, California, 92660
Clinical Site
Overland Park, Kansas, 66211
Clinical Site
Palm Bay, Florida, 32905
Clinical Site
Plymouth Meeting, Pennsylvania, 19462
Clinical Site
Riverside, California, 92506
Clinical Site
Rogers, Arkansas, 72758
Clinical Site
San Diego, California, 92103
Clinical Site
West Palm Beach, Florida, 33407
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
Argentina8 sites
Clinical Site
Buenos Aires, Ciudad Autonoma Buenos Aires, 1058 AAJ
Clinical Site
Buenos Aires, C10154ABQ
Clinical Site
Córdoba, Córdoba Province, 5000FJF
Clinical Site
Córdoba, Córdoba Province, 5000
Clinical Site
Córdoba, Córdoba Province, 5009
Clinical Site
Córdoba, Córdoba Province, X5003DCE
Clinical Site
Mendoza, Mendoza Province, M5502AHV
Clinical Site
Rosario, Santa Fe Province, S2000QJI
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
Bulgaria4 sites
Clinical Site
Plovdiv, 4004
Clinical Site
Sofia, 1408
Clinical Site
Sofia, 1680
Clinical Site
Targovishte, 7700
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
Change from baseline to Day 43 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. 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
Change from baseline to Day 43 in the Clinical Global Impression Scale-Severity (CGI-S). 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 posted29 Sep 2021
- Study start30 Sep 2021
- Primary completion12 Apr 2024
- Study completion12 Apr 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.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 480 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
- NCT05061706
- Sponsor's protocol ID
- ITI-007-502
- Status last verified
- Apr 2025
- First submitted
- 20 Sep 2021
- Last updated
- 9 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Clayton AH, Earley WR, Kozauer SG, Mo Y, Edwards JB, Durgam S. Evaluation of Sexual Function With Adjunctive Lumateperone in Patients With Major Depressive Disorder. J Clin Psychiatry. 2026 Sep 2;87(3):26m16387. doi: 10.4088/JCP.26m16387.
PubMed 42690086Earley WR, Durgam S, Kozauer SG, Chen C, Migliore R, Correll CU. Safety and Tolerability of Adjunctive Lumateperone for the Treatment of Major Depressive Disorder: A Pooled Analysis of Two Randomized Placebo-Controlled Trials. CNS Drugs. 2026 Jul 15. doi: 10.1007/s40263-026-01314-8. Online ahead of print.
PubMed 42455478
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. 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
- NCT05061706
- Acronym / sponsor ID
- ITI-007-502
- Conditions
- Major Depressive Disorder
- Keywords
- Adjunctive MDD Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Intra-Cellular Therapies, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 12 Apr 2024 (actual)
- Study completion
- 12 Apr 2024 (actual)
- First posted
- 29 Sep 2021 (actual)
- Results
- Posted 25 Mar 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, 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 MINI and meets all of the following criteria:
- Currently having an inadequate response to ADT (less than 50% improvement) as confirmed by the Investigator 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
Change from baseline to Day 43 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. 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
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42690086Clayton AH, Earley WR, Kozauer SG, Mo Y, Edwards JB, Durgam S. Evaluation of Sexual Function With Adjunctive Lumateperone in Patients With Major Depressive Disorder. J Clin Psychiatry. 2026 Sep 2;87(3):26m16387. doi: 10.4088/JCP.26m16387.
- Derived from this study: PubMed 42455478Earley WR, Durgam S, Kozauer SG, Chen C, Migliore R, Correll CU. Safety and Tolerability of Adjunctive Lumateperone for the Treatment of Major Depressive Disorder: A Pooled Analysis of Two Randomized Placebo-Controlled Trials. CNS Drugs. 2026 Jul 15. doi: 10.1007/s40263-026-01314-8. Online ahead of print.
- 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.
50 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 50 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: finished, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States, Poland, Argentina, Germany, Bulgaria 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?
Yes. Results are posted in the registry (first posted 25 Mar 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?
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?
On the ClinicalTrials.gov record for NCT05061706, which also lists 2 linked publications.
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 9 May 2025.