Phase 3
Completed N=528
Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression
Source: ClinicalTrials.gov NCT02600507 ↗Enrolled (actual)
528
Serious AEs
0.2%
Results posted
May 2023
Primary outcomePrimary: 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
◆ Published Evidence
Established
27citations · ~9 / year
Adjunctive lumateperone (ITI-007) in the treatment of bipolar depression: Results from a randomized placebo-controlled clinical trial.
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.
Linked Publications
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Adjunctive lumateperone (ITI-007) in the treatment of bipolar depression: Results from a randomized placebo-controlled clinical trial.
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 |
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) and the linked publication. 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. Informational only — not medical advice.