Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression

Phase 3

Completed

• Conditions: Bipolar Depression
• Interventions: Drug: Lumateperone (ITI-007); Drug: Placebo

• Registration Number: NCT02600507
• Lead Sponsor: Intra-Cellular Therapies, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-05
• Study First Submitted QC: 2015-11-06
• Study First Posted: 2015-11-09
• Study Start: 2016-03-07
• Primary Completion: 2020-07-02
• Study Completion: 2020-07-02
• Status Verified: 2021-04
• Results First Submitted: 2023-04-24
• Results First Submitted QC: 2023-04-24
• Last Update Submitted: 2023-04-24
• Results First Posted: 2023-05-17
• Last Update Posted: 2023-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 529

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lumateperone 42 mg (ITI-007 60 mg tosylate)	Lumateperone (ITI-007)	Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for 6 weeks
Lumateperone 28 mg (ITI-007 40 mg tosylate)	Lumateperone (ITI-007)	Lumateperone 28 mg (ITI-007 40 mg tosylate) administered orally as capsules once daily for 6 weeks
Placebo	Placebo	Placebo administered orally as visually-matched capsules once daily for 6 weeks

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score	Baseline to Day 43	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Clinical Global Impression Scale-Bipolar Version-Severity (CGI-BP-S) Depression Score	Baseline to Day 43	The Clinical Global Impression Scale-Bipolar Version-Severity (CGI-BP-S) Depression Score is a clinician-rated scale that measures the patient's current state of depression from 1 (not ill at all) to 7 (among the most extremely ill).

Trial Locations

Locations (1)

Clinical Site; 🇺🇦 Vinnytsia, Ukraine