Phase 3
N=377
Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally
Bipolar Depression
Bottom Line
View on ClinicalTrials.gov: NCT03249376 ↗Enrolled (actual)
377
Serious AEs
0.3%
Results posted
Jun 2022
Primary outcome: Primary: Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score — -16.70; -12.12 score on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lumateperone (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Intra-Cellular Therapies, Inc.
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score |
-16.70; -12.12 | <0.0001 sig |
| SECONDARY Change From Baseline in Clinical Global Impression Scale, Bipolar Version (CGI-BP-S) Total Score |
-3.48; -2.54 | <0.0001 sig |
| SECONDARY Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Percent Score |
19.4; 14.9 | 0.005 sig |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03249376). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.