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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
NCT05850689
Collaborator
(none)
470
Enrollment
18
Locations
2
Arms
29
Anticipated Duration (Months)
26.1
Patients Per Site
0.9
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
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2025
Anticipated Study Completion Date :
Oct 1, 2025

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 modified Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT) 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 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 using the Antidepressant Treatment Response Questionnaire (ATRQ) 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. Note: Anxiety symptoms may be allowed if secondary to MDD, provided these symptoms do not require concurrent treatment;

  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 Pico Rivera California United States 90660
2 Clinical Site Farmington Connecticut United States 06030
3 Clinical Site Clermont Florida United States 34711
4 Clinical Site Hialeah Florida United States 33012
5 Clinical Site Miami Florida United States 33122
6 Clinical Site Miami Florida United States 33180
7 Clinical Site Tampa Florida United States 33629
8 Clinical Site Decatur Georgia United States 30030
9 Clinical Site Kansas City Kansas United States 66160
10 Clinical Site Overland Park Kansas United States 66210
11 Clinical Site Methuen Massachusetts United States 01844
12 Clinical Site O'Fallon Missouri United States 63368
13 Clinical Site New York New York United States 10036
14 Clinical Site Avon Lake Ohio United States 44012
15 Clinical Site Columbus Ohio United States 43210
16 Clinical Site Philadelphia Pennsylvania United States 19104
17 Clinical Site Houston Texas United States 77081
18 Clinical Site Richardson Texas United States 75080

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:
NCT05850689
Other Study ID Numbers:
  • ITI-007-505
First Posted:
May 9, 2023
Last Update Posted:
May 10, 2023
Last Verified:
May 1, 2023
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 May 10, 2023