A Study to Evaluate the Efficacy and Safety of SPT-300 (GlyphAllo) in Participants With Major Depressive Disorder, With or Without Anxious Distress (BUOY-1 Study)

Официальное название

A Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Monotherapy Study of the Efficacy, Safety, and Tolerability of SPT-300 in Adults With Major Depressive Disorder (MDD), With or Without Anxious Distress

Обзор

This is a randomized, parallel-group, double-blind, placebo-controlled, monotherapy study to evaluate the efficacy, safety, and tolerability of SPT-300 (GlyphAllo) in adults with major depressive disorder (MDD), with or without anxious distress.

Вмешательства

• Препарат SPT-300
  A prodrug of allopregnanolone, a small molecule drug
• Препарат Placebo
  Placebo for SPT-300

Первичные конечные точки

• Change From Baseline to Day 42 in Hamilton Depression Rating Scale-17 (HAM-D-17) Total Score [Срок оценки: Baseline (Day 0) to Day 42]

Вторичные конечные точки (1)

• Change From Baseline to Day 42 in Clinical Global Impression - Severity (CGI-S) [Срок оценки: Baseline (Day 0) to Day 42]

Критерии участия

Критерии включения

• Participant is a male or female between 18 and 65 years of age, inclusive willing and able and have capacity to provide written informed consent.
• Participants must have a primary diagnosis of MDD. Participants with a diagnosis of comorbid generalized anxiety disorder, social anxiety disorder, or panic disorder (with or without agoraphobia) may be included if not the focus of treatment over the past 6 months prior to Screening and the Investigator considers MDD to be the primary diagnosis at Screening and Baseline.
• Eligible participants must have a current depressive episode of at least 4 weeks, but no greater than 18 months in duration prior to Screening.
• Women of childbearing potential (WOCP) must not plan to become pregnant during the course of the study or be currently breastfeeding. WOCP agree to use an acceptable form of highly effective contraception during participation in the study and for 30 days after receiving the last dose of study treatment.
• Body mass index (BMI) between 18 to 40 kg/m2, inclusive.
• Participant is willing and able to refrain from the use of drugs of abuse.

Критерии исключения

• History of, or current presentation consistent with:

• any depressive episode with psychotic or catatonic features.
• any bipolar manic, hypomanic or mixed episode, and substance-induced (e.g., antidepressant-induced) manic, hypomanic/mixed episode.
• bipolar disorder, including history of bipolar depression, or current presentation consistent with bipolar depression.
• schizophrenia, schizoaffective, or other psychotic disorder.
• obsessive-compulsive disorder.
• any persistent neurocognitive disorder.
• History of treatment-resistant depression defined as 2 or more failed treatments of adequate dose and duration in the current depressive episode.
• Psychiatric hospitalization within current depressive episode.
• Evidence or history of clinically significant diseases which can affect the patients' participation.
• Previous history of intolerance or significant adverse effects, including drug allergy to allopregnanolone or any components of the SPT-300/placebo formulation.
• Participant has a history of drug or alcohol use disorder.
• Participants with a positive test for cannabinoids.
• Clinically significant risk of suicide or harm to self or others.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 30 центров

• Seaport Investigator Site — Chino
• Seaport Investigator Site — Garden Grove
• Seaport Investigator Site — Glendale
• Seaport Investigator Site — Redlands
• Seaport Investigator Site — San Jose
• Seaport Investigator Site — Cromwell
• Seaport Investigator Site — Jacksonville
• Seaport Investigator Site — Lauderhill
• … и ещё 22 центра

Польша · 12 центров

• Seaport Investigator Site — Bełchatów
• Seaport Investigator Site — Bialystok
• Seaport Investigator Site — Bialystok
• Seaport Investigator Site — Bydgoszcz
• Seaport Investigator Site — Gdansk
• Seaport Investigator Site — Katowice
• Seaport Investigator Site — Leszno
• Seaport Investigator Site — Poznan
• … и ещё 4 центра

Чехия · 6 центров

• Seaport Investigator Site — Brno
• Seaport Investigator Site — Pilsen
• Seaport Investigator Site — Prague
• Seaport Investigator Site — Prague
• Seaport Investigator Site — Prague
• Seaport Investigator Site — Prague

Германия · 4 центра

• Seaport Investigator Site — Berlin
• Seaport Investigator Site — Schwerin
• Seaport Investigator Site — Bad Homburg
• Seaport Investigator Site — Chemnitz

Болгария · 3 центра

• Seaport Investigator Site — Plovdiv
• Seaport Investigator Site — Sofia
• Seaport Investigator Site — Sofia

Венгрия · 3 центра

• Seaport Investigator Site — Budapest
• Seaport Investigator Site — Budapest
• Seaport Investigator Site — Budapest

Словакия · 3 центра

• Seaport Investigator Site — Bratislava
• Seaport Investigator Site — Rimavská Sobota
• Seaport Investigator Site — Vranov nad Topľou

Идентификаторы

NCT: NCT07065240 · SPT-300-2024-203 · 2025-521240-37-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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