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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Lumateperone

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 Type: Interventional
• Enrollment (Estimated): 760
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Burgas, Bulgaria, 8001
    • Clinical Site
  • Kazanlak, Bulgaria, 6100
    • Clinical Site
  • Novi Iskar, Bulgaria, 1282
    • Clinical Site
  • Pleven, Bulgaria, 5809
    • Clinical Site
  • Plovdiv, Bulgaria, 4004
    • Clinical Site
  • Ruse, Bulgaria, 7003
    • Clinical Site
  • Sofia, Bulgaria, 1408
    • Clinical Site
  • Sofia, Bulgaria, 1680
    • Clinical Site
  • Targovishte, Bulgaria, 7700
    • Clinical Site
  • Tsarev Brod, Bulgaria, 9747
    • Clinical Site
  • Veliko Tarnovo, Bulgaria, 5000
    • Clinical Site
  • Veliko Tarnovo, Bulgaria, 5047
    • Clinical Site
  • Vratsa, Bulgaria, 3001
    • Clinical Site
• Czechia
  • Brno, Czechia, 60200
    • Clinical Site
  • Brno, Czechia, 615 00
    • Clinical Site
  • Hostivice, Czechia, 253 01
    • Clinical Site
  • Ostrava, Czechia, 708 00
    • Clinical Site
  • Plzen, Czechia, 301 00
    • Clinical Site
  • Prague, Czechia, 100 00
    • Clinical Site
  • Prague, Czechia, 160 00
    • Clinical Site
  • Prague, Czechia, 186 00
    • Clinical Site
• Finland
  • Helsinki, Finland, 00100
    • Clinical Site
  • Oulu, Finland, 90100
    • Clinical Site
• Germany
  • Bad Homburg, Germany, 61348
    • Clinical Site
  • Freiburg Im Breisgau, Germany, 79104
    • Clinical Site
  • Hamburg, Germany, 20253
    • Clinical Site
  • Mittweida, Germany, 09648
    • Clinical Site
  • Schwerin, Germany, 19053
    • Clinical Site
  • Westerstede, Germany, 26655
    • Clinical Site
• Hungary
  • Budapest, Hungary, 1033
    • Clinical Site
  • Budapest, Hungary, 1083
    • Clinical Site
  • Budapest, Hungary, 1134
    • Clinical Site
  • Budapest, Hungary, 1135
    • Clinical Site
  • Debrecen, Hungary, 4032
    • Clinical Site
  • Gyöngyös, Hungary, 3200
    • Clinical Site
• India
  • Mumbai, India, 400008
    • Clinical Site
  • Nashik, India, 422005
    • Clinical Site
  • Assam
    • Guwahati, Assam, India, 781010
      • Clinical Site
  • Gujarat
    • Ahmedabad, Gujarat, India, 380013
      • Clinical Site
    • Jūnāgadh, Gujarat, India, 362001
      • Clinical Site
    • Vadodara, Gujarat, India, 390021
      • Clinical Site
  • Karnataka
    • Mysore, Karnataka, India, 570001
      • Clinical Site
  • Maharashtra
    • Aurangabad, Maharashtra, India, 431005
      • Clinical Site
    • Nagpur, Maharashtra, India, 440010
      • Clinical Site
    • Nashik, Maharashtra, India, 422001
      • Clinical Site
• Korea, Republic of
  • Gwangju, Korea, Republic of, 61469
    • Clinical Site
  • Seoul, Korea, Republic of, 01830
    • Clinical Site
  • Seoul, Korea, Republic of, 03080
    • Clinical Site
  • Seoul, Korea, Republic of, 06351
    • Clinical Site
  • Chungcheongbuk-do
    • Ansan-si, Chungcheongbuk-do, Korea, Republic of, 15355
      • Clinical Site
• Poland
  • Belchatow, Poland, 97-400
    • Clinical Site
  • Białystok, Poland, 15-404
    • Clinical Site
  • Białystok, Poland, 15-464
    • Clinical Site
  • Białystok, Poland, 15-879
    • Clinical Site
  • Bydgoszcz, Poland, 85-080
    • Clinical Site
  • Gdańsk, Poland, 80-546
    • Clinical Site
  • Gorlice, Poland, 38-300
    • Clinical Site
  • Leszno, Poland, 64-100
    • Clinical Site
  • Pruszcz Gdański, Poland, 83-000
    • Clinical Site
  • Toruń, Poland, 87-100
    • Clinical Site
  • Wrocław, Poland, 50-414
    • Clinical Site
• Slovakia
  • Bratislava, Slovakia, 82007
    • Clinical Site
  • Košice, Slovakia, 04001
    • Clinical Site
  • Rimavská Sobota, Slovakia, 979 01
    • Clinical Site
  • Svidník, Slovakia, 089 01
    • Clinical Site
  • Vranov Nad Topľou, Slovakia, 09301
    • Clinical Site
  • Zlaté Moravce, Slovakia, 953 01
    • Clinical Site
• Sweden
  • Lund, Sweden, 22222
    • Clinical Site
  • Stockholm, Sweden, 11329
    • Clinical Site
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Clinical Site
  • Arkansas
    • Bentonville, Arkansas, United States, 72712
      • Clinical Site
    • Little Rock, Arkansas, United States, 72211
      • Clinical Site
    • Rogers, Arkansas, United States, 72758
      • Clinical Site
  • California
    • Culver City, California, United States, 90230
      • Clinical Site
    • Glendale, California, United States, 91206
      • Clinical Site
    • Newport Beach, California, United States, 92660
      • Clinical Site
    • Oceanside, California, United States, 92056
      • Clinical Site
    • Redlands, California, United States, 92374
      • Clinical Site
    • Riverside, California, United States, 92506
      • Clinical Site
    • San Diego, California, United States, 92103
      • Clinical Site
    • Sherman Oaks, California, United States, 91403
      • Clinical Site
    • Temecula, California, United States, 92951
      • Clinical Site
    • Upland, California, United States, 91786
      • Clinical Site
  • Florida
    • Fort Lauderdale, Florida, United States, 33319
      • Clinical Site
    • Jacksonville, Florida, United States, 32256
      • Clinical Site
    • Orlando, Florida, United States, 32801
      • Clinical Site
    • Palm Bay, Florida, United States, 32905
      • Clinical Site
    • West Palm Beach, Florida, United States, 33407
      • Clinical Site
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Clinical Site
    • Atlanta, Georgia, United States, 30328
      • Clinical Site
    • Atlanta, Georgia, United States, 30329
      • Clinical Site
    • Decatur, Georgia, United States, 30030
      • Clinical Site
  • Illinois
    • Joliet, Illinois, United States, 60435
      • Clinical Site
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Clinical Site
  • Maryland
    • Gaithersburg, Maryland, United States, 20877
      • Clinical Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Clinical Site
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Clinical Site
  • Missouri
    • Saint Charles, Missouri, United States, 63304
      • Clinical Site
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Clinical Site
    • Toms River, New Jersey, United States, 08755
      • Clinical Site
  • New York
    • Brooklyn, New York, United States, 11235
      • Clinical Site
    • Cedarhurst, New York, United States, 11516
      • Clinical Site
    • Mount Kisco, New York, United States, 10549
      • Clinical Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28211
      • Clinical Site
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Clinical Site
    • Media, Pennsylvania, United States, 19063
      • Clinical Site
    • Plymouth Meeting, Pennsylvania, United States, 19462
      • Clinical Site
  • Texas
    • Austin, Texas, United States, 78737
      • Clinical Site
  • Washington
    • Bellevue, Washington, United States, 98007
      • Clinical Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. In the opinion of the Investigator, the patient is unable to comply with study procedures or judged to be inappropriate for the study.

2. 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:

   1. At the Screening/Baseline Visit, the patient scores "yes" on Suicidal Ideation Items 4 or 5 of the C SSRS "Since Last Visit" version;
   2. At the Screening/Baseline visit, the patient scores ≥ 5 on the MADRS Item 10 (Suicidal Thoughts).
3. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number and percentage of patients reporting Treatment Emergent Adverse Events	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.	26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montgomery-Åsberg Depression Rating Scale	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.	26 weeks
Clinical Global Impression Scale-Severity	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).	26 weeks

Collaborators and Investigators

• Sponsor: Intra-Cellular Therapies, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2021
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: September 20, 2021
• First Posted (Actual): September 29, 2021

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Adjunctive MDD Therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: ITI-007-503

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No