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

Sponsor
Intra-Cellular Therapies, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05061706
Collaborator
(none)
470
Enrollment
17
Locations
2
Arms
24
Anticipated Duration (Months)
27.6
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
470 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 30, 2021
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lumateperone 42 mg

Drug: Lumateperone
Lumateperone 42 mg capsules administered orally, once daily.
Placebo Comparator: Placebo

Drug: Placebo
Matching capsules administered orally, once daily.

Outcome Measures

Primary Outcome Measures

  1. Montgomery-Asberg Depression Rating Scale [Day 43]

    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

  1. Clinical Global Impression Scale-Severity [Day 43]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

  3. The start of the current major depressive episode (MDE) is at least 8 weeks but not more than 18 months prior to Screening;

  4. Has at least moderate severity of illness based on rater-administered MADRS total score ≥ 24 at Screening and at Baseline;

  5. Has at least moderate severity of illness based on CGI-S score ≥ 4 at Screening (Visit 1) and at Baseline;

  6. Has a Quick Inventory of Depressive Symptomatology-Self Report-16 item (QIDS-SR-16) score ≥ 14 at Screening and at Baseline;

  7. 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.

  8. 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:

  9. citalopram/escitalopram

  10. fluoxetine

  11. paroxetine

  12. sertraline

  13. duloxetine

  14. levomilnacipran/milnacipran (if locally approved for MDD)

  15. venlafaxine/desvenlafaxine

  16. bupropion

  17. vilazodone

  18. 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;

  3. 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;

  6. The patient experiences a ≥ 25% decrease in the MADRS total score between Screening and Baseline;

  7. The patient experiences a ≥ 25% decrease in the QIDS-SR-16 total score between Screening and Baseline;

  8. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during participation in the study or:

  9. 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;

  10. At Screening, the patient has had 1 or more suicide attempts within 2 years prior to Screening;

  11. At Screening or Baseline, the patient scores ≥ 5 on MADRS Item 10 (Suicidal Thoughts), or

  12. The patient is considered to be in imminent danger to him/herself or others.

  13. The patient has a first MDE at age 60 years or older.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinical Site Little Rock Arkansas United States 72211
2 Clinical Site Rogers Arkansas United States 72758
3 Clinical Site Newport Beach California United States 92660
4 Clinical Site Riverside California United States 92506
5 Clinical Site San Diego California United States 92103
6 Clinical Site Palm Bay Florida United States 32905
7 Clinical Site West Palm Beach Florida United States 33407
8 Clinical Site Atlanta Georgia United States 30329
9 Clinical Site Overland Park Kansas United States 66211
10 Clinical Site Gaithersburg Maryland United States 20877
11 Clinical Site Flowood Mississippi United States 39232
12 Clinical Site Brooklyn New York United States 11235
13 Clinical Site Charlotte North Carolina United States 28211
14 Clinical Site Allentown Pennsylvania United States 18104
15 Clinical Site Media Pennsylvania United States 19063
16 Clinical Site Plymouth Meeting Pennsylvania United States 19462
17 Clinical Site Bellevue Washington United States 98007

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:
NCT05061706
Other Study ID Numbers:
  • ITI-007-502
First Posted:
Sep 29, 2021
Last Update Posted:
Apr 8, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
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