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Clinical trial

Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of ITI-007 Adjunctive to Lithium or Valproate in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder

ID
Name
ITI-007-402
Description
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.
Trial arms
Trial start
2016-03-07
Estimated PCD
2020-07-02
Trial end
2020-07-02
Status
Completed
Phase
Early phase I
Treatment
Lumateperone (ITI-007)
Arms:
Lumateperone 28 mg (ITI-007 40 mg tosylate), Lumateperone 42 mg (ITI-007 60 mg tosylate)
Placebo
Arms:
Placebo
Size
529
Primary endpoint
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Baseline to Day 43
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 529, 'type': 'ACTUAL'}}
Updated at
2023-05-17

1 organization

2 products

1 indication

Organization
Intra-Cellular Therapies
Product
Placebo
Indication
Bipolar disorder
Product
Lumateperone