Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally

Phase 3

Completed

• Conditions: Bipolar Depression
• Interventions: Other: Placebo; Drug: Lumateperone

• Registration Number: NCT03249376
• Lead Sponsor: Intra-Cellular Therapies, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-11
• Study First Submitted QC: 2017-08-11
• Study First Posted: 2017-08-15
• Study Start: 2017-11-27
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-01
• Disposition First Submitted: 2020-04-09
• Results First Submitted: 2022-04-20
• Status Verified: 2022-05
• Results First Submitted QC: 2022-05-10
• Disposition First Submitted QC: 2022-05-10
• Last Update Submitted: 2022-05-10
• Results First Posted: 2022-06-03
• Disposition First Posted: 2022-06-03
• Last Update Posted: 2022-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 381

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo administered once daily every evening for 6 weeks
Lumateperone	Lumateperone	Lumateperone 42 mg (ITI-007 60 mg tosylate) administered once daily every evening 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 (CGI-BP-S) Total Score	Baseline to Day 43	The Clinical Global Impression Scale, Bipolar version (CGI-BP-S) total score is a clinician-rated scale that measures the patient's current illness state on a 3 to 21 point scale where a higher score is associated with greater illness severity.. Each domain (depression, mania, and overall illness) is rated from 1 (not ill at all) to 7 (among the most extremely ill) and the 3 scores are added to obtain the total score.
Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Percent Score	Baseline to Day 43	The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 14 item patient self-reported questionnaire that assesses how satisfied a patient is, using a 5-point scale from 1-very poor to 5-very good.

Trial Locations

Locations (1)

Clinical Site; 🇺🇦 Vinnytsia, Ukraine