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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04985942
Other study ID # ITI-007-501
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date July 30, 2021
Est. completion date February 27, 2024

Study information

Verified date April 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 42mg/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 Completed
Enrollment 485
Est. completion date February 27, 2024
Est. primary completion date February 22, 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. Meet DSM-5 diagnostic criteria for MDD (a diagnosis of MDD with psychotic features will be acceptable) as confirmed by the Investigator or Sponsor-approved rater using the Mini-International Neuropsychiatric Interview (MINI), and meet all 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 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. buproprion 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
Bulgaria Clinical Site Burgas
Bulgaria Clinical Site Kazanlak
Bulgaria Clinical Site Pleven
Bulgaria Clinical Site Ruse
Bulgaria Clinical Site Tsarev Brod
Bulgaria Clinical Site Veliko Tarnovo
Bulgaria Clinical Site Veliko Tarnovo
Bulgaria Clinical Site Vratsa
Czechia Clinical Site Brno
Czechia Clinical Site Brno
Czechia Clinical Site Ostrava
Czechia Clinical site Plzen
Czechia Clinical Site Prague
Czechia Clinical Site Prague
Hungary Clinical Site Budapest
Hungary Clinical Site Budapest
Hungary Clinical Site Budapest
Hungary Clinical Site Gyöngyös
India Clinical Site Ahmedabad Gujarat
India Clinical Site Aurangabad Maharashtra
India Clinical Site Guwahati Assam
India Clinical Site Jaipur Rajasthan
India Clinical Site Junagadh Gujarat
India Clinical Site Kozhikode Kerala
India Clinical Site Lucknow Uttar Pradesh
India Clinical Site Ludhiana Punjab
India Clinical Site Mangaluru Karnataka
India Clinical Site Mysore Karnataka
India Clinical Site Nagpur Maharashtra
India Clinical Site Nashik Maharashtra
India Clinical Site Nashik Maharashtra
India Clinical Site Vadodara Gujarat
India Clinical Site Varanasi Uttar Pradesh
Slovakia Clinical Site Bratislava
Slovakia Clinical Site Košice
Slovakia Clinical Site Rimavská Sobota
Slovakia Clinical Site Svidník
Slovakia Clinical Site Vranov Nad Toplou
Slovakia Clinical Site Zlaté Moravce
United States Clinical Site Austin Texas
United States Clinical Site Berlin New Jersey
United States Clinical Site Boston Massachusetts
United States Clinical Site Cedarhurst New York
United States Clinical Site Decatur Georgia
United States Clinical Site Fort Lauderdale Florida
United States Clinical Site Glendale California
United States Clinical Site Jacksonville Florida
United States Clinical Site Oceanside California
United States Clinical Site Orlando Florida
United States Clinical Site Phoenix Arizona
United States Clinical Site Redlands California
United States Clinical Site Temecula California
United States Clinical Site Toms River New Jersey
United States Clinical Site Upland California

Sponsors (1)

Lead Sponsor Collaborator
Intra-Cellular Therapies, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Czechia,  Hungary,  India,  Slovakia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Montgomery-Åsberg 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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