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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05061706
• Other study ID #: ITI-007-502
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 30, 2021
• Est. completion date: May 2024

Study information

• Verified date: March 2024
• Source: Intra-Cellular Therapies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 480
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
Argentina	Clinical Site	Ciudad Autonoma de Buenos Aires	Ciudad Autonoma Buenos Aires
Argentina	Clinical Site	Ciudad Autonoma de Buenos Aires
Argentina	Clinical Site	Ciudad de Mendoza	Mendoza
Argentina	Clinical Site	Córdoba	Cordoba
Argentina	Clinical Site	Córdoba	Cordoba
Argentina	Clinical Site	Córdoba	Cordoba
Argentina	Clinical Site	Córdoba	Cordoba
Argentina	Clinical Site	Rosario	Santa Fe
Bulgaria	Clinical Site	Plovdiv
Bulgaria	Clinical Site	Sofia
Bulgaria	Clinical Site	Sofia
Bulgaria	Clinical Site	Targovishte
Finland	Clinical Site	Helsinki
Finland	Clinical Site	Oulu
Germany	Clinical Site	Bad Homburg
Germany	Clinical site	Freiburg im Breisgau
Germany	Clinical Site	Hamburg
Germany	Clinical Site	Mittweida
Germany	Clinical Site	Schwerin
Germany	Clinical Site	Westerstede
Poland	Clinical Site	Belchatów
Poland	Clinical Site	Bialystok
Poland	Clinical Site	Bialystok
Poland	Clinical Site	Bialystok
Poland	Clinical Site	Bydgoszcz
Poland	Clinical Site	Gdansk
Poland	Clinical Site	Gorlice
Poland	Clinical Site	Leszno
Poland	Clinical Site	Pruszcz Gdanski
Poland	Clinical Site	Torun
Poland	Clinical Site	Wroclaw
Sweden	Clinical Site	Lund
Sweden	Clinical Site	Stockholm
United States	Clinical Site	Allentown	Pennsylvania
United States	Clinical Site	Atlanta	Georgia
United States	Clinical Site	Bellevue	Washington
United States	Clinical Site	Brooklyn	New York
United States	Clinical Site	Charlotte	North Carolina
United States	Clinical Site	Flowood	Mississippi
United States	Clinical Site	Gaithersburg	Maryland
United States	Clinical Site	Little Rock	Arkansas
United States	Clinical Site	Media	Pennsylvania
United States	Clinical Site	Newport Beach	California
United States	Clinical Site	Overland Park	Kansas
United States	Clinical Site	Palm Bay	Florida
United States	Clinical Site	Plymouth Meeting	Pennsylvania
United States	Clinical Site	Riverside	California
United States	Clinical Site	Rogers	Arkansas
United States	Clinical Site	San Diego	California
United States	Clinical Site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Intra-Cellular Therapies, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Bulgaria,  Finland,  Germany,  Poland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 43
Secondary	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).	Day 43