ALTO-100 in Bipolar Disorder With Depression (BD-D)

Официальное название

A Randomized, Double-Blind, Placebo-Controlled Study Followed by Open-Label Treatment of ALTO-100 in Adults With Bipolar Disorder Currently Experiencing a Major Depressive Episode

Обзор

The purpose of this study is to assess antidepressant efficacy differences between ALTO-100 and placebo during the Double-Blind period in patients with bipolar disorder I or II with current major depressive episode, when used adjunctively to a mood stabilizer and/or atypical antipsychotic, related to patient characteristics. Additionally, safety, tolerability, and efficacy will be assessed in a subsequent open label treatment period.

Вмешательства

• Препарат ALTO-100
  ALTO-100 40 mg tablet BID
• Препарат Placebo
  Placebo tablet BID

Первичные конечные точки

• To assess efficacy of ALTO-100 versus placebo on depression symptoms in bipolar disorder in a pre-defined subgroup of participants as measured by the mean change from Day 1 to Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score [Срок оценки: Change assessed from Day 1 to Week 6]

Вторичные конечные точки (9)

• To assess efficacy of ALTO-100 vs placebo for self-reported depressive symptoms in bipolar disorder patients in a pre- defined subgroup of participants as measured by the change from Day 1 to Week 6 in Patient Health Questionnaire, 9 item (PHQ-9) [Срок оценки: Assessed 4 times over a 6-week interval, from Day 1 to Week 6]
• To assess efficacy of ALTO-100 vs placebo in severity of bipolar disorder symptoms in a pre-defined subgroup of participants as measured by the change from Day 1 to Week 6 in Clinician Global Impression Scale-severity (CGI-S) [Срок оценки: Assessed 4 times over a 6-week interval, from Day 1 to Week 6]
• To assess efficacy of ALTO-100 vs placebo for depressive symptoms in MDD in a pre-defined subgroup as measured by the change from Day 1 to Week 6 in response (>50% improvement from baseline) and remission (total score of <10) rates based on MADRS [Срок оценки: Assessed 4 times over a 6-week interval, from Day 1 to Week 6]
• To assess efficacy of ALTO-100 vs placebo on depressive symptoms in bipolar disorder in all randomized participants as measured by the change from Day 1 to Week 6 on the MADRS [Срок оценки: Assessed 4 times over a 6-week interval, from Day 1 to Week 6]
• To evaluate the safety of ALTO-100 during both the DB and OL periods of the study as measured by the assessment of the incidence, severity, and relatedness of Treatment Emergent Adverse Events (TEAEs), SAEs, discontinuation due to TEAEs and deaths [Срок оценки: Assessed from Day 1 to Week 13]
• To evaluate the safety of ALTO-100 during both the DB and OL periods of the study as measured by the assessment of Heart Rate in bpm [Срок оценки: Assessed from Day 1 to Week 13]
• To evaluate the safety of ALTO-100 during both the DB and OL periods of the study as measured by the assessment of Blood Pressure in mmHg [Срок оценки: Assessed from Day 1 to Week 13]
• To evaluate the safety of ALTO-100 during both the DB and OL periods of the study as measured by the assessment of Weight in pounds [Срок оценки: Assessed from Day 1 to Week 13]
• To evaluate the safety of ALTO-100 during both the DB and OL 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 13]

Критерии участия

Критерии включения

• Have a diagnosis of BD-I or BD-II as well as BD-D
• At baseline, taking a mood stabilizer, lithium (LI) or lamotrigine (LMG) or valproic acid (VPA, any form) or combination of Li + LMG or Li + VPA and/or taking an approved atypical antipsychotic medication (olanzapine, quetiapine, lurasidone, risperidone, ziprasidone, cariprazine, aripiprazole, lumateperone, and asenapine) for at least 6 weeks with no dose modifications in the past 2 weeks
• 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
• Concurrent use of any prohibited medications or substance use disorder
• Diagnosed psychotic disorder (other than mania or depression)
• Current moderate or severe substance use disorder
• Has a history of hypersensitivity or allergic reaction to ALTO-100 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 · 27 центров

• Site 6036 — Chandler
• Site 6000 — Phoenix
• Site 6087 — Yuma
• 6039 — Fayetteville
• 6070 — Little Rock
• Site 6081 — Imperial
• 6069 — Los Angeles
• Site 6016 — Mather
• … и ещё 19 центров

Идентификаторы

NCT: NCT06656416 · ALTO-100-211

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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