Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03249376 |
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Recruitment Status :
Completed
First Posted : August 15, 2017
Last Update Posted : April 14, 2020
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Sponsor:
Intra-Cellular Therapies, Inc.
Information provided by (Responsible Party):
Intra-Cellular Therapies, Inc.
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Brief Summary:
The study will evaluate the efficacy and safety of ITI-007 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bipolar Depression | Drug: Lumateperone Other: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 381 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Lumateperone Monotherapy in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression) Conducted Globally |
| Actual Study Start Date : | November 2, 2017 |
| Actual Primary Completion Date : | April 9, 2019 |
| Actual Study Completion Date : | April 9, 2019 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Depression
Drug Information available for:
Lumateperone
| Arm | Intervention/treatment |
|---|---|
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Experimental: Lumateperone
Lumateperone (ITI-007 60 mg) administered once daily every evening for 6 weeks
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Drug: Lumateperone
Lumateperone (ITI-007 60 mg)
Other Name: ITI-007 |
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Placebo Comparator: Placebo
Placebo administered once daily every evening for 6 weeks
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Other: Placebo
Placebo |
Primary Outcome Measures :
- Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Day 43 ]
Secondary Outcome Measures :
- Clinical Global Impression Scale, Bipolar version (CGI-BP) [ Time Frame: Day 43 ]
- Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) [ Time Frame: Day 43 ]
Information from the National Library of Medicine
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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 |
Criteria
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
- able to provide written informed consent
Major Exclusion Criteria:
- any female subject who is pregnant or breast-feeding
- any subject judged to be medically inappropriate for study participation
Information from the National Library of Medicine
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): NCT03249376
Locations
| United States, Alabama | |
| Clinical Site | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Clinical Site | |
| Sherman Oaks, California, United States, 91403 | |
| United States, Florida | |
| Clinical Site | |
| Miami, Florida, United States, 33133 | |
| Clinical Site | |
| Orange City, Florida, United States, 32763 | |
| United States, Georgia | |
| Clinical Site | |
| Atlanta, Georgia, United States, 30322 | |
| Clinical Site | |
| Decatur, Georgia, United States, 30030 | |
| United States, Illinois | |
| Clinical Site | |
| Chicago, Illinois, United States, 60612 | |
| Clinical Site | |
| Joliet, Illinois, United States, 60435 | |
| United States, Louisiana | |
| Clinical Site | |
| Shreveport, Louisiana, United States, 71101 | |
| United States, Missouri | |
| Clinical Site | |
| Saint Louis, Missouri, United States, 63128 | |
| United States, New York | |
| Clinical Site | |
| Buffalo, New York, United States, 14215 | |
| United States, North Carolina | |
| Clinical Site | |
| Charlotte, North Carolina, United States, 28211 | |
| United States, Texas | |
| Clinical Site | |
| The Woodlands, Texas, United States, 77381 | |
| United States, Washington | |
| Clinical Site | |
| Bothell, Washington, United States, 98011 | |
| Bulgaria | |
| Clinical Site | |
| Burgas, Bulgaria | |
| Clinical Site | |
| Kardzhali, Bulgaria | |
| Clinical Site | |
| Lovech, Bulgaria | |
| Clinical Site | |
| Plovdiv, Bulgaria | |
| Clinical Site | |
| Ruse, Bulgaria | |
| Clinical Site | |
| Sofia, Bulgaria | |
| Clinical Site | |
| Targovishte, Bulgaria | |
| Clinical Site | |
| Tzarev Brod, Bulgaria | |
| Clinical Site | |
| Varna, Bulgaria | |
| Clinical Site | |
| Veliko Tarnovo, Bulgaria | |
| Colombia | |
| Clinical Site | |
| Barranquilla, Colombia | |
| Clinical Site | |
| Bello, Colombia | |
| Clinical Site | |
| Pereira, Colombia | |
| Russian Federation | |
| Clinical Site | |
| Ekaterinburg, Russian Federation | |
| Clinical Site | |
| Moscow, Russian Federation | |
| Clinical Site | |
| Nizhny Novgorod, Russian Federation | |
| Clinical Site | |
| Omsk, Russian Federation | |
| Clinical Site | |
| Saint Petersburg, Russian Federation | |
| Clinical Site | |
| Samara, Russian Federation | |
| Clinical Site | |
| Saratov, Russian Federation | |
| Clinical Site | |
| Tomsk, Russian Federation | |
| Serbia | |
| Clinical Site | |
| Belgrade, Serbia | |
| Clinical Site | |
| Kragujevac, Serbia | |
| Clinical Site | |
| Novi Sad, Serbia | |
| Ukraine | |
| Clinical Site | |
| Ivano-Frankivs'k, Ukraine | |
| Clinical Site | |
| Kharkiv, Ukraine | |
| Clinical Site | |
| Kherson, Ukraine | |
| Clinical Site | |
| Lviv, Ukraine | |
| Clinical Site | |
| Odesa, Ukraine | |
| Clinical Site | |
| Poltava, Ukraine | |
| Clinical Site | |
| Smila, Ukraine | |
| Clinical Site | |
| Uzhgorod, Ukraine | |
| Clinical Site | |
| Vinnytsia, Ukraine | |
Sponsors and Collaborators
Intra-Cellular Therapies, Inc.
Investigators
| Study Director: | Susan Kozauer, MD | Intra-Cellular Therapies, Inc. |
| Responsible Party: | Intra-Cellular Therapies, Inc. |
| ClinicalTrials.gov Identifier: | NCT03249376 |
| Other Study ID Numbers: |
ITI-007-404 |
| First Posted: | August 15, 2017 Key Record Dates |
| Last Update Posted: | April 14, 2020 |
| Last Verified: | April 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Depression Depressive Disorder Bipolar Disorder Behavioral Symptoms |
Mood Disorders Mental Disorders Bipolar and Related Disorders |