Phase 3
N=528
Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression
Bipolar Depression
Bottom Line
View on ClinicalTrials.gov: NCT02600507 ↗Enrolled (actual)
528
Serious AEs
0.2%
Results posted
May 2023
Primary outcome: Primary: Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score — -16.2; -16.9; -14.5 score on a scale — p=0.021
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lumateperone (ITI-007) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Intra-Cellular Therapies, Inc.
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score |
-16.2; -16.9; -14.5 | 0.021 sig |
| SECONDARY Change From Baseline in Clinical Global Impression Scale-Bipolar Version-Severity (CGI-BP-S) Depression Score |
-1.7; -1.8; -1.5 | 0.008 sig |
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.
Eligibility Criteria
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
- treatment with either lithium or valproate and inadequate therapeutic response of depressive symptoms
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02600507). 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.