An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Sponsor

Intra-Cellular Therapies, Inc. (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05061719

Collaborator

(none)

760

Enrollment

Locations

Arm

30.8

Anticipated Duration (Months)

16.9

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multicenter, open-label, fixed dose, 26 week study of patients with MDD. Eligible patients from the lead-in studies will enter the Open-label Safety Study at the Screening/Baseline Visit (Visit 1/Day 1), at which point patient eligibility will be assessed and informed consent obtained.

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

Detailed Description

At the Screening/Baseline Visit (Visit 1/Day 1), which is the same visit as Visit 8/Day 43 of the lead-in study, eligible patients will receive open-label lumateperone 42 mg once daily for approximately 26 weeks. Patients will continue their background ADT from the lead-in study. Patients will be seen for weekly visits through Visit 5/Week 4. Thereafter, visits will occur every two weeks. A Safety Follow-up visit will occur on Visit 17/Day 197, approximately 2 weeks after the last dose of open-label lumateperone 42 mg.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

760 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Actual Study Start Date :

Oct 8, 2021

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lumateperone 42 mg	Drug: Lumateperone Lumateperone 42 mg capsules administered orally, once daily

Arm

Intervention/Treatment

Experimental: Lumateperone 42 mg

Drug: Lumateperone

Lumateperone 42 mg capsules administered orally, once daily

Outcome Measures

Primary Outcome Measures

The number and percentage of patients reporting Treatment Emergent Adverse Events [26 weeks]
An AE that occurs during the Open-label Treatment Period will be considered a treatment-emergent AE (TEAE) if it was not present before the date of the first dose of open-label lumateperone or was present before the date of the first dose of open-label lumateperone but changed in severity during the Open-label Treatment Period.

Secondary Outcome Measures

Montgomery-Åsberg Depression Rating Scale [26 weeks]
The 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.
Clinical Global Impression Scale-Severity [26 weeks]
The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not ta all ill) to 7 (among the most extremely ill patients).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

In the opinion of the Investigator, patients must have safely completed the lead-in study.
Patient is taking their ADT as prescribed from the lead-in study.

Exclusion Criteria:

In the opinion of the Investigator, the patient is unable to comply with study procedures or judged to be inappropriate for the study.
In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during the course of her/his participation in the study or is considered to be an imminent danger to her/himself or others, and/or:
At the Screening/Baseline Visit, the patient scores "yes" on Suicidal Ideation Items 4 or 5 of the C SSRS "Since Last Visit" version;
At the Screening/Baseline visit, the patient scores ≥ 5 on the MADRS Item 10 (Suicidal Thoughts).
Based on the Investigator's clinical judgement, any abnormal clinical laboratory test or ECG results obtained throughout the lead-in study that are considered clinically significant and preclude safe participation in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Site	Phoenix	Arizona	United States	85012
2	Clinical Site	Bentonville	Arkansas	United States	72712
3	Clinical Site	Little Rock	Arkansas	United States	72211
4	Clinical Site	Rogers	Arkansas	United States	72758
5	Clinical Site	Glendale	California	United States	91206
6	Clinical Site	Newport Beach	California	United States	92660
7	Clinical Site	Oceanside	California	United States	92056
8	Clinical Site	Redlands	California	United States	92374
9	Clinical Site	Riverside	California	United States	92506
10	Clinical Site	San Diego	California	United States	92103
11	Clinical Site	Temecula	California	United States	92951
12	Clinical Site	Upland	California	United States	91786
13	Clinical Site	Fort Lauderdale	Florida	United States	33319
14	Clinical Site	Jacksonville	Florida	United States	32256
15	Clinical Site	Orlando	Florida	United States	32801
16	Clinical Site	Palm Bay	Florida	United States	32905
17	Clinical Site	West Palm Beach	Florida	United States	33407
18	Clinical Site	Atlanta	Georgia	United States	30329
19	Clinical Site	Decatur	Georgia	United States	30030
20	Clinical Site	Joliet	Illinois	United States	60435
21	Clinical Site	Overland Park	Kansas	United States	66211
22	Clinical Site	Gaithersburg	Maryland	United States	20877
23	Clinical Site	Boston	Massachusetts	United States	02131
24	Clinical Site	Flowood	Mississippi	United States	39232
25	Clinical Site	Toms River	New Jersey	United States	08755
26	Clinical Site	Brooklyn	New York	United States	11235
27	Clinical Site	Charlotte	North Carolina	United States	28211
28	Clinical Site	Allentown	Pennsylvania	United States	18104
29	Clinical Site	Media	Pennsylvania	United States	19063
30	Clinical Site	Plymouth Meeting	Pennsylvania	United States	19462
31	Clinical Site	Austin	Texas	United States	78737
32	Clinical Site	Bellevue	Washington	United States	98007
33	Clinical Site	Burgas		Bulgaria	8001
34	Clinical Site	Kazanlak		Bulgaria	6100
35	Clinical Site	Novi Iskar		Bulgaria	1282
36	Clinical Site	Pleven		Bulgaria	5809
37	Clinical Site	Ruse		Bulgaria	7003
38	Clinical Site	Tsarev Brod		Bulgaria	9747
39	Clinical Site	Veliko Tarnovo		Bulgaria	5000
40	Clinical Site	Veliko Tarnovo		Bulgaria	5047
41	Clinical Site	Vratsa		Bulgaria	3001
42	Clinical Site	Brno		Czechia	60200
43	Clinical site	Brno		Czechia	615 00
44	Clinical Site	Bratislava		Slovakia	82007
45	Clinical Site	Vranov Nad Topľou		Slovakia	09301

Sponsors and Collaborators

Intra-Cellular Therapies, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Intra-Cellular Therapies, Inc.

ClinicalTrials.gov Identifier:

NCT05061719

Other Study ID Numbers:

ITI-007-503

First Posted:

Sep 29, 2021

Last Update Posted:

Apr 8, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Intra-Cellular Therapies, Inc.

Adjunctive MDD Therapy

Additional relevant MeSH terms:

Depressive Disorder

Depression

Depressive Disorder, Major

Study Results

No Results Posted as of Apr 8, 2022