Study of ALTO-300 in MDD

Официальное название

A Randomized, Double-Blind, Placebo-Controlled Study of ALTO-300 With an Open-Label Extension in Adults With Major Depressive Disorder

Обзор

The purpose of this study is to determine efficacy differences between ALTO-300 and placebo, used adjunctively to an antidepressant, related to patient characteristics.

Вмешательства

• Препарат ALTO-300
  ALTO-300 capsule QD
• Препарат Placebo
  Placebo capsule QD

Первичные конечные точки

• To assess efficacy of adjunctive ALTO-300 versus placebo on symptoms of MDD in a pre-defined subgroup of participants as measured by the change over time up to week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS). [Срок оценки: Change over time for up to week 6]

Вторичные конечные точки (7)

• To assess efficacy of adjunctive ALTO-300 versus placebo on symptoms of MDD in all randomized participants as measured by the change over time up to week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) [Срок оценки: Change over time for up to week 6]
• To assess efficacy of adjunctive ALTO-300 versus placebo for MDD as measured by the change over time up to week 6 in response (>50% improvement from baseline) rates based on the MADRS [Срок оценки: Change over time for up to week 6]
• To evaluate the safety of ALTO-300 during both the OL and DB periods of the study as measured by the assessment of the incidence, severity, and relatedness of Adverse Events. [Срок оценки: Assessed from Day 1 to Week 14]
• To evaluate the safety of ALTO-300 during both the OL and DB periods of the study as measured by the assessment of Heart Rate. [Срок оценки: Assessed from Day 1 to Week 14]
• To evaluate the safety of ALTO-300 during both the OL and DB periods of the study as measured by the assessment of Weight. [Срок оценки: Assessed from Day 1 to Week 14]
• To evaluate the safety of ALTO-300 during both the OL and DB periods of the study as measured by the assessment of Blood Pressure. [Срок оценки: Assessed from Day 1 to Week 14]
• To evaluate the safety of ALTO-300 during both the OL and DB periods of the study as measured by the assessment of suicidality with the Concise Health Risk Tracking Self-Report,12 item scale (CHRT-SR12). [Срок оценки: Assessed from Day 1 to Week 15]

Критерии участия

Критерии включения

• Have a diagnosis of moderate to severe major depressive disorder (MDD)
• At Visit 1, currently taking a single SSRI, SNRI, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks by Visit 2
• Willing to comply with all study assessments and procedures
• Must not be pregnant or breastfeeding at time of enrollment or throughout study

Критерии исключения

• Evidence of unstable medical condition
• Nightly use of sleep medication
• Diagnosed bipolar disorder, psychotic disorder, or dementia
• Current moderate or severe substance use disorder
• Has a history of hypersensitivity or allergic reaction to ALTO-300 or any of its components/excipients
• Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device

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 · 45 центров

• Site 200 — Phoenix
• Site 189 — Phoenix
• Site 187 — Yuma
• Site 193 — Rogers
• Site 218 — Bellflower
• Site 217 — Glendale
• Site 335 — Lafayette
• Site 209 — Los Angeles
• … и ещё 37 центров

Идентификаторы

NCT: NCT05922878 · ALTO-300-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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