Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder

Sponsor

Intra-Cellular Therapies, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04285515

Collaborator

(none)

450

Enrollment

Locations

Arms

33.1

Anticipated Duration (Months)

10.7

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of lumateperone monotherapy in the treatment of patients with major depressive episodes associated with Bipolar I or Bipolar II Disorder (Bipolar Depression) or major depressive disorder (MDD) who also meet the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM-5) criteria for mixed-features. The study consists of a Screening Period, a Double-blind Treatment Period, and a Safety Follow-up Period.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Depression Major Depressive Disorder	Drug: Lumateperone Drug: Placebos	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

450 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Lumateperone Monotherapy in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression) or Major Depressive Disorder

Actual Study Start Date :

Feb 27, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lumateperone 42mg Lumateperone 42mg administered once daily in the evening	Drug: Lumateperone Lumateperone 42mg oral capsule
Placebo Comparator: Placebo Matching placebo administered once daily in the evening	Drug: Placebos Placebo oral capsule

Arm

Intervention/Treatment

Experimental: Lumateperone 42mg

Lumateperone 42mg administered once daily in the evening

Drug: Lumateperone

Lumateperone 42mg oral capsule

Placebo Comparator: Placebo

Matching placebo administered once daily in the evening

Drug: Placebos

Placebo oral capsule

Outcome Measures

Primary Outcome Measures

Montgomery-Åsberg Depression Rating Scale [Day 43]

Secondary Outcome Measures

Clinical Global Impression Scale - Severity [Day 43]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Major Inclusion Criteria:

Male or female subjects of any race, ages 18-75 inclusive
Meets the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM 5) criteria for Bipolar I or Bipolar II Disorder or MDD
The start of the current major depressive episode is at least 2 weeks but no more than 6 months prior to the Screening (Visit 1)
Has at least moderate severity of illness, as measured by a rater-administered MADRS total score ≥ 24 and corresponding to a CGI S score of ≥ 4 at Screening (Visit 1) and Baseline (Visit 2)
The patient meets the DSM-5 criteria for mixed-features specific to the Bipolar I or II diagnosis or MDD diagnosis
Current major depressive episode is causing clinically significant distress or impairment in social, occupational, or other important areas of functioning
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
The patient has a significant risk for suicidal behavior
The patient presents with a lifetime history of epilepsy, seizure or convulsion, or electroencephalogram with clinically significant abnormalities, delirium, dementia, amnestic, or other cognitive disorder or significant brain trauma

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Site	Garden Grove	California	United States	92845
2	Clinical Site	Oceanside	California	United States	92056
3	Clinical Site	Sherman Oaks	California	United States	91403
4	Clinical Site	Lauderhill	Florida	United States	33319
5	Clinical Site	Miami	Florida	United States	33122
6	Clinical Site	Orange City	Florida	United States	32763
7	Clinical Site	Atlanta	Georgia	United States	30331
8	Clinical Site	Decatur	Georgia	United States	30030
9	Clinical Site	O'Fallon	Missouri	United States	63368
10	Clinical Site	Cedarhurst	New York	United States	11694
11	Clinical Site	New York	New York	United States	10128
12	Clinical Site	Charlotte	North Carolina	United States	28211
13	Clinical Site	Bellevue	Washington	United States	98007
14	Clinical Site	Burgas		Bulgaria	8000
15	Clinical Site	Kardzhali		Bulgaria	6600
16	Clinical Site	Plovdiv		Bulgaria	4004
17	Clinical Site	Ruse		Bulgaria	7003
18	Clinical Site	Sofia		Bulgaria	1113
19	Clinical Site	Sofia		Bulgaria	1408
20	Clinical Site	Sofia		Bulgaria	1431
21	Clinical Site	Sofia		Bulgaria	1680
22	Clinical Site	Varna		Bulgaria	9020
23	Clinical Site	Veliko Tarnovo		Bulgaria	5000
24	Clinical Site	Vratsa		Bulgaria	3000
25	Clinical Site	Ekaterinburg		Russian Federation	620030
26	Clinical Site	Moscow		Russian Federation	105082
27	Clinical Site	Saint Petersburg		Russian Federation	190121
28	Clinical Site	Saint Petersburg		Russian Federation	192019
29	Clinical Site	Saint Petersburg		Russian Federation	195160
30	Clinical Site	Saint Petersburg		Russian Federation	197341
31	Clinical Site	Saint Petersburg		Russian Federation	199106
32	Clinical Site	Tomsk		Russian Federation	634009
33	Clinical Site	Belgrade		Serbia	11000
34	Clinical Site	Kovin		Serbia	26220
35	Clinical Site	Kragujevac		Serbia	34000
36	Clinical Site	Kyiv		Ukraine	1133
37	Clinical Site	Lviv		Ukraine	79021
38	Clinical site	Odesa		Ukraine	65006
39	Clinical Site	Odesa		Ukraine	67513
40	Clinical Site	Poltava		Ukraine	36013
41	Clinical Site	Smila		Ukraine	20708
42	Clinical Site	Vinnytsia		Ukraine	21005