Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression
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ClinicalTrials.gov Identifier: NCT02600494 |
Recruitment Status :
Completed
First Posted : November 9, 2015
Last Update Posted : April 14, 2021
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Condition or disease | Intervention/treatment | Phase |
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Bipolar Depression | Drug: ITI-007 (Lumateperone) Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 554 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study 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 |
Actual Study Start Date : | December 15, 2015 |
Actual Primary Completion Date : | January 28, 2019 |
Actual Study Completion Date : | July 24, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: 40 mg ITI-007 (Lumateperone)
40 mg ITI-007 (Lumateperone) administered orally as capsules once daily for 6 weeks
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Drug: ITI-007 (Lumateperone) |
Experimental: 60 mg ITI-007 (Lumateperone)
60 mg ITI-007 (Lumateperone) administered orally as capsules once daily for 6 weeks
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Drug: ITI-007 (Lumateperone) |
Placebo Comparator: Placebo
Placebo administered orally as visually-matched capsules once daily for 6 weeks
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Drug: Placebo |
- Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 6 weeks ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02600494

Study Director: | Susan Kozauer, MD | Intra-Cellular Therapies, Inc. (ITI) |
Responsible Party: | Intra-Cellular Therapies, Inc. |
ClinicalTrials.gov Identifier: | NCT02600494 |
Other Study ID Numbers: |
ITI-007-401 |
First Posted: | November 9, 2015 Key Record Dates |
Last Update Posted: | April 14, 2021 |
Last Verified: | April 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Depression Depressive Disorder Bipolar Disorder Behavioral Symptoms |
Mood Disorders Mental Disorders Bipolar and Related Disorders |