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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Lumateperone
  Lumateperone 42 mg capsules administered orally, once daily
• Препарат Placebo
  Matching capsules administered orally, once daily

Первичные конечные точки

• Montgomery-Asberg Depression Rating Scale [Срок оценки: Day 43]

Вторичные конечные точки (1)

• Clinical Global Impression Scale-Severity [Срок оценки: Day 43]

Критерии участия

Критерии включения

• Male or female patients between the ages of 18 and 65 years, inclusive;
• 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:

• The start of the current major depressive episode (MDE) is at least 12 weeks but not more than 18 months prior to Screening;
• Has at least moderate severity of illness based on rater-administered MADRS total score ≥ 24 at Screening and at Baseline;
• Has at least moderate severity of illness based on CGI-S score ≥ 4 at Screening and at Baseline;
• Has a Quick Inventory of Depressive Symptomatology-Self Report-16 item (QIDS-SR-16) score ≥ 14 at Screening and at Baseline;
• 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.
• Currently having an inadequate response (less than 50% improvement) to 2 or more ADTs in the current MDE 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:

• citalopram/escitalopram
• fluoxetine
• paroxetine
• sertraline
• duloxetine
• levomilnacipran/milnacipran (if locally approved for MDD)
• venlafaxine/desvenlafaxine
• bupropion
• vilazodone
• vortioxetine

Критерии исключения

• Within the patient's lifetime, has a confirmed DSM-5 psychiatric diagnosis other than MDD, including:

• Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder;
• Bipolar Disorder;
• Within 6 months of Screening, has a confirmed DSM-5 psychiatric diagnosis other than MDD including:

• 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;
• Eating disorder;
• Substance use disorders (excluding nicotine);
• Personality disorder of sufficient severity to have a major impact on the patient's psychiatric status;
• Within 12 months of Screening, has had any other psychiatric condition (other than MDD) that has been the main focus of treatment;
• The patient experiences a ≥ 25% decrease in the MADRS total score between Screening and Baseline;
• The patient experiences a ≥ 25% decrease in the QIDS-SR-16 total score between Screening and Baseline;
• In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during participation in the study or:

• 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;
• At Screening, the patient has had 1 or more suicide attempts within 2 years prior to Screening;
• At Screening or Baseline, the patient scores ≥ 5 on MADRS Item 10 (Suicidal Thoughts), or
• The patient is considered to be in imminent danger to him/herself or others.
• The patient has a first MDE at age 60 years or older.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 25 центров

• University of Alabama at Birmingham — Huntsville
• CNRI-Los Angeles, LLC — Pico Rivera
• University of Connecticut Health Center — Farmington
• Vertex Clinical Research — Clermont
• New Life Medical Research Center, Inc. — Hialeah
• Premier Clinical Research Institute — Miami
• Miami Jewish Health System — Miami
• Interventional Psychiatry of Tampa Bay — Tampa
• … и ещё 17 центров

Индия · 13 центров

• Ratandeep Surgical Hospital And Endoscopy Clinic — Ahmedabad
• Sushrusha Navneet Memorial Hospital — Ahmedabad
• J L N Medical College and Attached Hospitals — Ajmer
• Baramati Hospital — Bārāmati
• S P Medical College And Associated Group of Hospitals — Bikaner
• Post Graduate Institute of Medical Education And Research PGIMER — Chandigarh
• Gauhati Medical College and Hospital — Guwahati
• Swastik Hospital — Kolhāpur
• … и ещё 5 центров

Болгария · 10 центров

• Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Nats — Cherven Bryag
• Medical Center Lifemed — Kardzhali
• Medical Center Medconsult-Pleven — Pleven
• Medical Center Mentalcare OOD — Plovdiv
• MHC - Sofia, EOOD — Sofia
• University Multiprofile Hospital for Active Treatment - UMHAT Alexandrovska EAD — Sofia
• Medical Center Hera EOOD — Sofia
• Medical Center Intermedica, OOD — Sofia
• … и ещё 2 центра

Сербия · 9 центров

• Clinical Center Dr Dragisa Misovic Dedinje — Belgrade
• Institute of Mental Health Serbia — Belgrade
• University Clinical Center of Serbia — Belgrade
• Special Hospital for Psychiatric Diseases Kovin — Kovin
• University Clinical Center Kragujevac 1 — Kragujevac
• University Clinical Center Kragujevac — Kragujevac
• University Clinical Center NIS 1 — Niš
• University Clinical Center NIS — Niš
• … и ещё 1 центр

Франция · 5 центров

• Cabinet Medical des Drs Prizac-Desbonnet Scottez — Douai
• CHU de Nantes hotel Dieu — Nantes
• Hopital Caremeau — Nîmes
• Groupe Hospitalier Pitie-Salpetriere — Paris
• CH Henri Laborit — Poitiers

Испания · 5 центров

• Hosp Univ Vall D Hebron — Barcelona
• Hosp. Clinic de Barcelona — Barcelona
• Hosp. Univ. Ramon Y Cajal — Madrid
• Hosp.Univ.Parc Tauli — Sabadell
• Hosp. Prov. de Zamora — Zamora

Литва · 2 центра

• Romuvos Klinika, JSC — Kaunas
• Kaunas Hospital of Lithuanian University of Health Sciences Psychiatric Clinic Mariu divis — Ziegzdriai

Идентификаторы

NCT: NCT05850689 · ITI-007-505 · ITI-007-505

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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