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Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lumateperone
Placebo
Sponsored by
Intra-Cellular Therapies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Adjunctive MDD Therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female patients between the ages of 18 and 65 years, inclusive;
  2. Meets DSM-5 criteria for MDD (MDD with psychotic features will be acceptable) as confirmed by the Investigator or Sponsor-approved rater using the MINI and meets all of the following criteria:

    1. The start of the current major depressive episode (MDE) is at least 8 weeks but not more than 18 months prior to Screening;
    2. Has at least moderate severity of illness based on rater-administered MADRS total score ≥ 24 at Screening and at Baseline;
    3. Has at least moderate severity of illness based on CGI-S score ≥ 4 at Screening (Visit 1) and at Baseline;
    4. Has a Quick Inventory of Depressive Symptomatology-Self Report-16 item (QIDS-SR-16) score ≥ 14 at Screening and at Baseline;
    5. Has sufficient history and medical record confirmation verifying the ADT and the current MDE is causing clinically significant distress or impairment in social, occupational, or other important areas of functioning.
  3. Currently having an inadequate response to ADT (less than 50% improvement) as confirmed by the Investigator and taking at least the minimum effective dose (per package insert) of one of the following antidepressants as monotherapy treatment for at least 6 weeks duration:

    1. citalopram/escitalopram
    2. fluoxetine
    3. paroxetine
    4. sertraline
    5. duloxetine
    6. levomilnacipran/milnacipran (if locally approved for MDD)
    7. venlafaxine/desvenlafaxine
    8. bupropion
    9. vilazodone
    10. vortioxetine

Exclusion Criteria:

  1. Within the patient's lifetime, has a confirmed DSM-5 psychiatric diagnosis other than MDD, including:

    1. Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder;
    2. Bipolar Disorder;
  2. Within 6 months of Screening, has a confirmed DSM-5 psychiatric diagnosis other than MDD including:

    1. Anxiety disorders such as Panic Disorder or Generalized Anxiety Disorder; Obsessive-compulsive Disorder; Posttraumatic Stress Disorder as primary diagnoses.
    2. Eating disorder;
    3. Substance use disorders (excluding nicotine);
    4. Personality disorder of sufficient severity to have a major impact on the patient's psychiatric status;
    5. Within 12 months of Screening, has had any other psychiatric condition (other than MDD) that has been the main focus of treatment;
  3. The patient experiences a ≥ 25% decrease in the MADRS total score between Screening and Baseline;
  4. The patient experiences a ≥ 25% decrease in the QIDS-SR-16 total score between Screening and Baseline;
  5. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during participation in the study or:

    1. At Screening, the patient scores "yes" on Suicidal Ideation Items 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening, or at Baseline, the patient scores "yes" on Suicidal Ideation Items 4 or 5 since the Screening Visit;
    2. At Screening, the patient has had 1 or more suicide attempts within 2 years prior to Screening;
    3. At Screening or Baseline, the patient scores ≥ 5 on MADRS Item 10 (Suicidal Thoughts), or
    4. The patient is considered to be in imminent danger to him/herself or others.
  6. The patient has a first MDE at age 60 years or older.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lumateperone 42 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Montgomery-Asberg 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.

Secondary Outcome Measures

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 at all ill) to 7 (among the most extremely ill patients).

Full Information

First Posted
September 20, 2021
Last Updated
October 17, 2023
Sponsor
Intra-Cellular Therapies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05061706
Brief Title
Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
Official Title
A Randomized, Double-Blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2021 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intra-Cellular Therapies, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an inadequate response to ongoing ADT.
Detailed Description
The study will be conducted in three periods: Screening Period (up to 2 weeks) during which patient eligibility will be assessed; Double-blind Treatment Period (6 weeks) in which all patients will be randomized to receive placebo or lumateperone 42 mg/day in 1:1 ratio. Safety Follow-up Period (1 week) in which all patients will return to the clinic for a safety follow-up visit approximately one week after the last dose of study treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Adjunctive MDD Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
470 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lumateperone 42 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lumateperone
Intervention Description
Lumateperone 42 mg capsules administered orally, once daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching capsules administered orally, once daily.
Primary Outcome Measure Information:
Title
Montgomery-Asberg Depression Rating Scale
Description
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.
Time Frame
Day 43
Secondary Outcome Measure Information:
Title
Clinical Global Impression Scale-Severity
Description
The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Time Frame
Day 43

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients between the ages of 18 and 65 years, inclusive; Meets DSM-5 criteria for MDD (MDD with psychotic features will be acceptable) as confirmed by the Investigator or Sponsor-approved rater using the MINI and meets all of the following criteria: The start of the current major depressive episode (MDE) is at least 8 weeks but not more than 18 months prior to Screening; Has at least moderate severity of illness based on rater-administered MADRS total score ≥ 24 at Screening and at Baseline; Has at least moderate severity of illness based on CGI-S score ≥ 4 at Screening (Visit 1) and at Baseline; Has a Quick Inventory of Depressive Symptomatology-Self Report-16 item (QIDS-SR-16) score ≥ 14 at Screening and at Baseline; Has sufficient history and medical record confirmation verifying the ADT and the current MDE is causing clinically significant distress or impairment in social, occupational, or other important areas of functioning. Currently having an inadequate response to ADT (less than 50% improvement) as confirmed by the Investigator and taking at least the minimum effective dose (per package insert) of one of the following antidepressants as monotherapy treatment for at least 6 weeks duration: citalopram/escitalopram fluoxetine paroxetine sertraline duloxetine levomilnacipran/milnacipran (if locally approved for MDD) venlafaxine/desvenlafaxine bupropion vilazodone vortioxetine Exclusion Criteria: Within the patient's lifetime, has a confirmed DSM-5 psychiatric diagnosis other than MDD, including: Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder; Bipolar Disorder; Within 6 months of Screening, has a confirmed DSM-5 psychiatric diagnosis other than MDD including: Anxiety disorders such as Panic Disorder or Generalized Anxiety Disorder; Obsessive-compulsive Disorder; Posttraumatic Stress Disorder as primary diagnoses. Eating disorder; Substance use disorders (excluding nicotine); Personality disorder of sufficient severity to have a major impact on the patient's psychiatric status; Within 12 months of Screening, has had any other psychiatric condition (other than MDD) that has been the main focus of treatment; The patient experiences a ≥ 25% decrease in the MADRS total score between Screening and Baseline; The patient experiences a ≥ 25% decrease in the QIDS-SR-16 total score between Screening and Baseline; In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during participation in the study or: At Screening, the patient scores "yes" on Suicidal Ideation Items 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening, or at Baseline, the patient scores "yes" on Suicidal Ideation Items 4 or 5 since the Screening Visit; At Screening, the patient has had 1 or more suicide attempts within 2 years prior to Screening; At Screening or Baseline, the patient scores ≥ 5 on MADRS Item 10 (Suicidal Thoughts), or The patient is considered to be in imminent danger to him/herself or others. The patient has a first MDE at age 60 years or older.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ITI Clinical Trials
Phone
646 440-9333
Email
ITCIClinicalTrials@itci-inc.com
Facility Information:
Facility Name
Clinical Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Palm Bay
State/Province
Florida
ZIP/Postal Code
32905
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Plymouth Meeting
State/Province
Pennsylvania
ZIP/Postal Code
19462
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Sofia
ZIP/Postal Code
1408
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Sofia
ZIP/Postal Code
1680
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Targovishte
ZIP/Postal Code
7700
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Bad Homburg
ZIP/Postal Code
61348
Country
Germany
Individual Site Status
Recruiting
Facility Name
Clinical site
City
Freiburg im Breisgau
ZIP/Postal Code
79104
Country
Germany
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Hamburg
ZIP/Postal Code
20253
Country
Germany
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Mittweida
ZIP/Postal Code
09648
Country
Germany
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Schwerin
ZIP/Postal Code
19053
Country
Germany
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Westerstede
ZIP/Postal Code
26655
Country
Germany
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Bełchatów
ZIP/Postal Code
97-400
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Białystok
ZIP/Postal Code
15-404
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Białystok
ZIP/Postal Code
15-464
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Białystok
ZIP/Postal Code
15-879
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Bydgoszcz
ZIP/Postal Code
85-080
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Gdańsk
ZIP/Postal Code
80-546
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Gorlice
ZIP/Postal Code
38-300
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Leszno
ZIP/Postal Code
64-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Pruszcz Gdański
ZIP/Postal Code
83-000
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Toruń
ZIP/Postal Code
87-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Wrocław
ZIP/Postal Code
50-414
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Lund
ZIP/Postal Code
22222
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Stockholm
ZIP/Postal Code
11329
Country
Sweden
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

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