Bipolar DepressionPhase 3NCT02600507
Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression
A Phase 3 study testing Lumateperone (ITI-007) in people with Bipolar Depression, run by Intra-Cellular Therapies, Inc. at 71 sites in 5 countries.
Trial summary
The study will evaluate the efficacy and safety of ITI-007 adjunctive to lithium or valproate in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode. 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?
- Lumateperone (ITI-007)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 529 participants
- Where
- 71 sitesin 5 countries
- Study dates
- 7 Mar 2016to 2 Jul 2020
- 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
Who may be able to join
- 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
- treatment with either lithium or valproate and inadequate therapeutic response of depressive symptoms
Who cannot join
- any subject unable to provide informed consent
- any female subject who is pregnant or breastfeeding
- any subject judged to be medically inappropriate for study participation
Trial locations and contacts
71 sites in 5 countries.
71 sites in 5 countries
United States42 sites
Clinical Site
Allentown, Pennsylvania
Clinical Site
Atlanta, Georgia
Clinical Site
Baltimore, Maryland
Clinical Site
Berlin, New Jersey
Clinical Site
Cedarhurst, New York
Clinical Site
Cerritos, California
Clinical Site
Charlotte, North Carolina
Clinical Site
Cherry Hill, New Jersey
Clinical Site
Chicago, Illinois
Clinical Site
Cincinnati, Ohio
Clinical Site
Costa Mesa, California
Clinical Site
Culver City, California
Clinical Site
Dayton, Ohio
Clinical Site
Everett, Washington
Clinical Site
Garden Grove, California
Clinical Site
Garfield Heights, Ohio
Clinical Site
Glendale, California
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
Miami, Florida
Clinical Site
New York, New York
Clinical Site
O'Fallon, Missouri
Clinical Site
Oceanside, California
Clinical Site
Orange City, Florida
Clinical Site
Orlando, Florida
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
Santa Rosa, California
Clinical Site
Savannah, Georgia
Clinical Site
Sherman Oaks, California
Clinical Site
St Louis, Missouri
Clinical Site
Staten Island, New York
Clinical Site
Temecula, California
Clinical Site
The Woodlands, Texas
Clinical Site
Toms River, New Jersey
Bulgaria10 sites
Clinical Site
Burgas
Clinical Site
Kardzhali
Clinical Site
Lovech
Clinical Site
Pleven
Clinical Site
Plovdiv
Clinical Site
Rousse
Clinical Site
Sofia
Clinical Site
Varna
Clinical Site
Veliko Tarnovo
Clinical Site
Vratsa
Ukraine8 sites
Clinical Site
Ivano-Frankivsk
Clinical Site
Kharkiv
Clinical Site
Kropyvnytskyi
Clinical Site
Odesa
Clinical Site
Poltava
Clinical Site
Smila
Clinical Site
Vasylkiv
Clinical Site
Vinnytsia
Russia7 sites
Clinical Site
Moscow
Clinical Site
Nizhny Novgorod
Clinical Site
Omsk
Clinical Site
Saint Petersburg
Clinical Site
Samara
Clinical Site
Saratov
Clinical Site
Tomsk
Serbia4 sites
Clinical Site
Belgrade
Clinical Site
Kovin
Clinical Site
Novi Sad
Clinical Site
Šumadija
About this study
Official title: Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of ITI-007 Adjunctive to Lithium or Valproate in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder
The study will evaluate the efficacy and safety of ITI-007 adjunctive to lithium or valproate in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode.
- Conditions
- Bipolar Depression
- Being tested
- Lumateperone (ITI-007), 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.
Lumateperone (ITI-007)Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Lumateperone 28 mg (ITI-007 40 mg tosylate) | Experimental | Lumateperone 28 mg (ITI-007 40 mg tosylate) administered orally as capsules once daily for 6 weeks Receives: Drug: Lumateperone (ITI-007) |
| Lumateperone 42 mg (ITI-007 60 mg tosylate) | Experimental | Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for 6 weeks Receives: Drug: Lumateperone (ITI-007) |
| 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 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: Baseline to Day 43
Secondary outcomes (1)
Change From Baseline in Clinical Global Impression Scale-Bipolar Version-Severity (CGI-BP-S) Depression Score
The Clinical Global Impression Scale-Bipolar Version-Severity (CGI-BP-S) Depression Score is a clinician-rated scale that measures the patient's current state of depression from 1 (not ill at all) to 7 (among the most extremely ill).
Measured: Baseline to 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 Nov 2015 (estimated)
- Study start7 Mar 2016
- Primary completion2 Jul 2020
- Study completion2 Jul 2020
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 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
- 529 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intra-Cellular Therapies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susan Kozauer, MD, Study director, Intra-Cellular Therapies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02600507
- Sponsor's protocol ID
- ITI-007-402
- Status last verified
- Apr 2021
- First submitted
- 5 Nov 2015
- Last updated
- 17 May 2023
- 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 41017591Suppes T, Durgam S, Kozauer SG, Chen R, Lakkis HD, Davis RE, Satlin A, Vanover KE, Mates S, McIntyre RS, Tohen M. Adjunctive lumateperone (ITI-007) in the treatment of bipolar depression: Results from a randomized placebo-controlled clinical trial. Bipolar Disord. 2023 Sep;25(6):478-488. doi: 10.1111/bdi.13310. Epub 2023 Feb 26.
PubMed 36779257
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of ITI-007 Adjunctive to Lithium or Valproate in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder
- ClinicalTrials.gov ID
- NCT02600507
- Acronym / sponsor ID
- ITI-007-402
- Conditions
- Bipolar Depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 529 participants (actual)
- Lead sponsor
- Intra-Cellular Therapies, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Mar 2016 (actual)
- Primary completion
- 2 Jul 2020 (actual)
- Study completion
- 2 Jul 2020 (actual)
- First posted
- 9 Nov 2015 (estimated)
- Results
- Posted 17 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will evaluate the efficacy and safety of ITI-007 adjunctive to lithium or valproate in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode.
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 |
|---|---|---|
| Lumateperone 28 mg (ITI-007 40 mg tosylate) | Experimental | Drug: Lumateperone (ITI-007)Lumateperone 28 mg (ITI-007 40 mg tosylate) administered orally as capsules once daily for 6 weeks |
| Lumateperone 42 mg (ITI-007 60 mg tosylate) | Experimental | Drug: Lumateperone (ITI-007)Lumateperone 42 mg (ITI-007 60 mg tosylate) 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
Key inclusion criteria (3 listed)
- 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
- treatment with either lithium or valproate and inadequate therapeutic response of depressive symptoms
Key exclusion criteria (3 listed)
- any subject unable to provide informed consent
- any female subject who is pregnant or breastfeeding
- any subject judged to be medically inappropriate for study participation
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 |
|---|---|---|
| Lumateperone (ITI-007) | Drug | Lumateperone 28 mg (ITI-007 40 mg tosylate), Lumateperone 42 mg (ITI-007 60 mg tosylate) |
| Placebo | Drug | Placebo |
Primary outcome
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Time frame: Baseline to Day 43
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
Change From Baseline in Clinical Global Impression Scale-Bipolar Version-Severity (CGI-BP-S) Depression Score
Time frame: Baseline to Day 43
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- 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.
- Derived from this study: PubMed 36779257Suppes T, Durgam S, Kozauer SG, Chen R, Lakkis HD, Davis RE, Satlin A, Vanover KE, Mates S, McIntyre RS, Tohen M. Adjunctive lumateperone (ITI-007) in the treatment of bipolar depression: Results from a randomized placebo-controlled clinical trial. Bipolar Disord. 2023 Sep;25(6):478-488. doi: 10.1111/bdi.13310. Epub 2023 Feb 26.
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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.
Susan Kozauer, MD study director
Intra-Cellular Therapies, Inc.
71 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lumateperone (ITI-007) in people with Bipolar Depression, run by Intra-Cellular Therapies, Inc. at 71 sites in 5 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 3 inclusion and 3 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 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 sites in United States, Bulgaria, Ukraine, Russia, Serbia. 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 17 May 2023). 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 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score (time frame: Baseline to 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 NCT02600507, 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 17 May 2023.