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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05061706
Other study ID # ITI-007-502
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


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
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