Bipolar DepressionPhase 3NCT02600494

Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression

A Phase 3 study testing ITI-007 (Lumateperone) in people with Bipolar Depression, run by Intra-Cellular Therapies, Inc. at 55 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The study will evaluate the efficacy and safety of ITI-007 (Lumateperone) in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode. The study will be conducted in two parts, Part A and Part B. Part A is a randomized, double-blind, placebo-controlled study. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Bipolar Depression
What is being tested?: ITI-007 (Lumateperone)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 554 participants
Where: 55 sitesUnited States
Study dates: 15 Dec 2015to 24 Jul 2019
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Major Inclusion Criteria:

male or female subjects of any race, ages 18-75 inclusive, with a clinical diagnosis of Bipolar I or Bipolar II disorder
experiencing a current major depressive episode

Major Exclusion Criteria:

any subject unable to provide informed consent
any female subject who is pregnant or breast-feeding
any subject judged to be medically inappropriate for study participation

Trial locations and contacts

55 sites in 1 country.

City, postcode or hospital

55 sites in 1 country

United States55 sites

Clinical Site
Allentown, Pennsylvania
Clinical Site
Atlanta, Georgia
Clinical Site
Austin, Texas
Clinical Site
Baltimore, Maryland
Clinical Site
Berlin, New Jersey
Clinical Site
Boston, Massachusetts
Clinical Site
Bradenton, Florida
Clinical Site
Brooklyn, New York
Clinical Site
Cedarhurst, New York
Clinical Site
Cerritos, California
Clinical Site
Cherry Hill, New Jersey
Clinical Site
Chicago, Illinois
Clinical Site
Cincinnati, Ohio
Clinical Site
Cleveland, Ohio
Clinical Site
Colorado Springs, Colorado
Clinical Site
Culver City, California
Clinical Site
Dallas, Texas
Clinical Site
Dayton, Ohio
Clinical Site
Everett, Washington
Clinical Site
Fort Myers, Florida
Clinical Site
Garden Grove, California
Clinical Site
Garfield Heights, Ohio
Clinical Site
Hoffman Estates, Illinois
Clinical Site
Houston, Texas
Clinical Site
Jacksonville, Florida
Clinical Site
Lake Charles, Louisiana
Clinical Site
Las Vegas, Nevada
Clinical Site
Lauderhill, Florida
Clinical Site
Lemon Grove, California
Clinical Site
Little Rock, Arkansas
Clinical Site
Marlton, New Jersey
Clinical Site
Memphis, Tennessee
Clinical Site
Miami, Florida
Clinical Site
National City, California
Clinical Site
New York, New York
Clinical Site
Norristown, Pennsylvania
Clinical Site
North Miami, Florida
Clinical Site
O'Fallon, Missouri
Clinical Site
Oakland, California
Clinical Site
Oceanside, California
Clinical Site
Oklahoma City, Oklahoma
Clinical Site
Orange, California
Clinical Site
Orlando, Florida
Clinical Site
Petersburg, Virginia
Clinical Site
Philadelphia, Pennsylvania
Clinical Site
Pico Rivera, California
Clinical Site
Riverside, California
Clinical Site
Rochester, New York
Clinical Site
Rogers, Arkansas
Clinical Site
San Diego, California
Clinical Site
San Marcos, California
Clinical Site
Santa Rosa, California
Clinical Site
St Louis, Missouri
Clinical Site
Staten Island, New York
Clinical Site
Toms River, New Jersey

Other trials in United States

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study With an Open-Label Extension to Assess the Efficacy and Safety of ITI-007 Monotherapy in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression)

Conditions: Bipolar Depression
Being tested: ITI-007 (Lumateperone), Placebo
Medical subject headings: Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ITI-007 (Lumateperone)Drug
PlaceboDrug

Study groups in NCT02600494
Study group	Role	What they receive
40 mg ITI-007 (Lumateperone)	Experimental	40 mg ITI-007 (Lumateperone) administered orally as capsules once daily for 6 weeks Receives: Drug: ITI-007 (Lumateperone)
60 mg ITI-007 (Lumateperone)	Experimental	60 mg ITI-007 (Lumateperone) administered orally as capsules once daily for 6 weeks Receives: Drug: ITI-007 (Lumateperone)
Placebo	Placebo comparator	Placebo administered orally as visually-matched capsules once daily for 6 weeks Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline to Day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
The Montgomery-Åsberg Depression Rating Scale (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: 6 weeks

Secondary outcomes (1)

Time to First Sustained Response in Reduction of MADRS Total Score
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Dec 201524 Jul 2019

First posted9 Nov 2015 (estimated)
Study start15 Dec 2015
Primary completion28 Jan 2019
Study completion24 Jul 2019

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 (1)Papers the sponsor has linked to this study.
Other trials for Bipolar DepressionStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 554 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02600494
Sponsor's protocol ID: ITI-007-401
Status last verified: Oct 2025
First submitted: 5 Nov 2015
Last updated: 3 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Durgam S, Lakkis H, Kozauer SG, Chen C, McIntyre RS. Efficacy of Lumateperone in depression associated with bipolar II disorder: a pooled analysis of late-phase clinical trials. CNS Spectr. 2025 Sep 29;30(1):e80. doi: 10.1017/S1092852925100564.
PubMed 41017591

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
RecruitingPhase 3
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
Bipolar Depression
RecruitingObservational study
Natural History of Depression, Bipolar Disorder and Suicide Risk
Behavioral Symptoms, Suicide
Recruiting
Evaluation of the Impact of the EDIT-B® Blood Test on the Health Status of Patients Presenting a Major Depressive Episode. Clinical Utility and Medico-Economic Aspects
Bipolar Disorder, Major Depressive Disorder

All Bipolar Depression trials

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: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study With an Open-Label Extension to Assess the Efficacy and Safety of ITI-007 Monotherapy in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression)
ClinicalTrials.gov ID: NCT02600494
Acronym / sponsor ID: ITI-007-401
Conditions: Bipolar Depression
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 554 participants (actual)
Lead sponsor: Intra-Cellular Therapies, Inc.Industry (pharma, biotech, devices)
Study start: 15 Dec 2015 (actual)
Primary completion: 28 Jan 2019 (actual)
Study completion: 24 Jul 2019 (actual)
First posted: 9 Nov 2015 (estimated)
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
40 mg ITI-007 (Lumateperone)	Experimental	Drug: ITI-007 (Lumateperone)40 mg ITI-007 (Lumateperone) administered orally as capsules once daily for 6 weeks
60 mg ITI-007 (Lumateperone)	Experimental	Drug: ITI-007 (Lumateperone)60 mg ITI-007 (Lumateperone) administered orally as capsules once daily for 6 weeks
Placebo	Placebo comparator	Drug: PlaceboPlacebo administered orally as visually-matched capsules once daily for 6 weeks

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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
ITI-007 (Lumateperone)	Drug	40 mg ITI-007 (Lumateperone), 60 mg ITI-007 (Lumateperone)
Placebo	Drug	Placebo

Primary outcome

Change From Baseline to Day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Time frame: 6 weeks
The Montgomery-Åsberg Depression Rating Scale (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

Time to First Sustained Response in Reduction of MADRS Total Score
Time frame: 6 weeks

Results and safety

Results posted to the registry on 3 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lumateperone 28 mg (ITI-007 40 mg Tosylate)	183	126
Lumateperone 42 mg (ITI-007 60 mg Tosylate)	185	113
Placebo	186	138

Primary outcome: Change From Baseline to Day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score

Time frame: 6 weeks. Least squares mean (Standard Error). Unit: score on a scale

Measure	Lumateperone 28 mg (ITI-007 40 mg Tosylate) n = 172	Lumateperone 42 mg (ITI-007 60 mg Tosylate) n = 166	Placebo n = 177
Value	-18.9 (1.11)	-20.7 (1.16)	-19.7 (1.11)

Lumateperone 28 mg (ITI-007 40 mg Tosylate) vs Placebo: Least Squares Mean Difference: 0.9 (95% CI -1.83 to 3.53), p = 0.514, Mixed Effects Model for Repeated Measure
Lumateperone 42 mg (ITI-007 60 mg Tosylate): Least Squares Mean Difference: -1.0 (95% CI -3.73 to 1.79), p = 0.895, Mixed Effects Model for Repeated Measure

Population analysed: Intent-to-Treat (ITT) Set contains all randomized patients who received at least one dose of study medication and who had a valid baseline (pre-dose) measurement and at least one valid post-baseline measurement of MADRS total score.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A Lumateperone 28 mg (ITI-007 40 mg Tosylate)	5 of 180 (2.8%)	72 of 180 (40%)	0 of 180
Part A Lumateperone 42 mg (ITI-007 60 mg Tosylate)	0 of 184 (0%)	67 of 184 (36.4%)	0 of 184
Part A Placebo	1 of 185 (0.5%)	31 of 185 (16.8%)	1 of 185
Part B Lumateperone 42 mg (ITI-007 60 mg Tosylate)	4 of 127 (3.1%)	55 of 127 (43.3%)	0 of 127

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.
Derived from this study: PubMed 41017591Durgam S, Lakkis H, Kozauer SG, Chen C, McIntyre RS. Efficacy of Lumateperone in depression associated with bipolar II disorder: a pooled analysis of late-phase clinical trials. CNS Spectr. 2025 Sep 29;30(1):e80. doi: 10.1017/S1092852925100564.

Related trials for Bipolar Depression

Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
RecruitingPhase 3
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
Bipolar Depression
RecruitingObservational study
Natural History of Depression, Bipolar Disorder and Suicide Risk
Behavioral Symptoms, Suicide
Recruiting
Evaluation of the Impact of the EDIT-B® Blood Test on the Health Status of Patients Presenting a Major Depressive Episode. Clinical Utility and Medico-Economic Aspects
Bipolar Disorder, Major Depressive Disorder

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.

Susan Kozauer, MD study director

Intra-Cellular Therapies, Inc. (ITI)

55 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ITI-007 (Lumateperone) in people with Bipolar Depression, run by Intra-Cellular Therapies, Inc. at 55 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 55 sites in United States. 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 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?

Change From Baseline to Day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score (time frame: 6 weeks). 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 NCT02600494, which also lists 1 linked publication.

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.