A Phase 3 interventional study of Lumateperone and Placebo in Bipolar Depression, sponsored by Intra-Cellular Therapies, Inc.. Completed at 47 sites in 6 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-06-03.
Sponsored by Intra-Cellular Therapies, Inc. · Phase 3, Interventional, and Treatment
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 381 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Intra-Cellular Therapies, Inc. is the lead sponsor of 40 studies on the registry; 12 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 10 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Major Inclusion Criteria:
Major Exclusion Criteria:
Lumateperone 42 mg (ITI-007 60 mg tosylate) administered once daily every evening for 6 weeks
Drug: Lumateperone
Placebo administered once daily every evening for 6 weeks
Other: Placebo
Lumateperone 42 mg (ITI-007 60 mg tosylate)
Also known as: ITI-007
Placebo
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.
Time frame: Baseline to Day 43
Change From Baseline in Clinical Global Impression Scale, Bipolar Version (CGI-BP-S) Total Score
The Clinical Global Impression Scale, Bipolar version (CGI-BP-S) total score is a clinician-rated scale that measures the patient's current illness state on a 3 to 21 point scale where a higher score is associated with greater illness severity.. Each domain (depression, mania, and overall illness) is rated from 1 (not ill at all) to 7 (among the most extremely ill) and the 3 scores are added to obtain the total score.
Time frame: Baseline to Day 43
Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Percent Score
The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 14 item patient self-reported questionnaire that assesses how satisfied a patient is, using a 5-point scale from 1-very poor to 5-very good.
Time frame: Baseline to Day 43
| Milestone | Lumateperone | Placebo |
|---|---|---|
| Started | 188 | 189 |
| Completed | 167 | 166 |
| Not completed | 21 | 23 |
| Withdrew: Adverse event | 11 | 5 |
| Withdrew: Lack of efficacy | 2 | 4 |
| Withdrew: Protocol violation | 3 | 2 |
| Withdrew: Physician decision | 0 | 2 |
| Withdrew: Withdrawal by subject | 3 | 9 |
| Withdrew: Ltfu | 2 | 1 |
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.
| score on a scale | Lumateperone | Placebo |
|---|---|---|
| Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | -16.70 ± 0.693 | -12.12 ± 0.677 |
The Clinical Global Impression Scale, Bipolar version (CGI-BP-S) total score is a clinician-rated scale that measures the patient's current illness state on a 3 to 21 point scale where a higher score is associated with greater illness severity.. Each domain (depression, mania, and overall illness) is rated from 1 (not ill at all) to 7 (among the most extremely ill) and the 3 scores are added to obtain the total score.
| score on a scale | Lumateperone | Placebo |
|---|---|---|
| Change From Baseline in Clinical Global Impression Scale, Bipolar Version (CGI-BP-S) Total Score | -3.48 ± 0.170 | -2.54 ± 0.167 |
The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 14 item patient self-reported questionnaire that assesses how satisfied a patient is, using a 5-point scale from 1-very poor to 5-very good.
| Percent Score | Lumateperone | Placebo |
|---|---|---|
| Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Percent Score | 19.4 ± 1.49 | 14.9 ± 1.45 |
Collected over From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lumateperone | 0/188 (0%) | 1/188 (0.5%) | 58/188 (30.9%) |
| Placebo | 0/189 (0%) | 0/189 (0%) | 31/189 (16.4%) |
| Event | Lumateperone | Placebo |
|---|---|---|
| ManiaPsychiatric disorders | 1/188 | 0/189 |
| Event | Lumateperone | Placebo |
|---|---|---|
| HeadacheNervous system disorders | 33/188 | 19/189 |
| SomnolenceNervous system disorders | 16/188 | 2/189 |
| NauseauGastrointestinal disorders | 12/188 | 4/189 |
| DizzinessNervous system disorders | 9/188 | 10/189 |
| Age, Continuous(years) | Lumateperone | Placebo | Total |
|---|---|---|---|
| Mean | 45.7 ± 14.09 | 44.1 ± 12.87 | 44.9 ± 13.50 |
| Sex: Female, Male(Participants) | Lumateperone | Placebo | Total |
|---|---|---|---|
| Female | 99 | 120 | 219 |
| Male | 89 | 69 | 158 |
| Race/Ethnicity, Customized(Participants) | Lumateperone | Placebo | Total |
|---|---|---|---|
| Caucasian/White | 173 | 171 | 344 |
| Black or African American | 14 | 15 | 29 |
| Asian | 1 | 0 | 1 |
| Other | 0 | 3 | 3 |
| Region of Enrollment(participants) | Lumateperone | Placebo | Total |
|---|---|---|---|
| United States | 51 | 59 | 110 |
| Ukraine | 49 | 38 | 87 |
| Bulgaria | 49 | 43 | 92 |
| Serbia | 6 | 13 | 19 |
| Russia | 32 | 34 | 66 |
| Colombia | 1 | 2 | 3 |
| Montgomery-Asberg Depression Rating Scale (MADRS)(units on a scale) | Lumateperone | Placebo | Total |
|---|---|---|---|
| Mean | 30.8 ± 4.92 | 30.2 ± 4.65 | 30.5 ± 4.79 |
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Intra-Cellular Therapies, Inc.