Study to Assess Adverse Events and Change in Disease Activity When Oral ABBV-932 is Added to Antidepressant Therapies in Adult Participants With Generalized Anxiety Disorder

Официальное название

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose Study to Evaluate the Efficacy, Safety, and Tolerability of ABBV-932 as an Adjunct to Antidepressant Therapies in the Treatment of Subjects With Generalized Anxiety Disorder Who Have Had an Inadequate Response to Antidepressant Therapies

Обзор

Generalized anxiety disorder (GAD) is usually treated with antidepressant therapy (ADT); however, sometimes ADTs alone are not enough to adequately treat GAD. The purpose of this study is to assess how safe and effective ABBV-932 is when added to the antidepressant therapies in adult participants with GAD who have had an inadequate response ADTs. ABBV-932 is an investigational drug being developed for the adjunctive treatment of GAD. Participants will be randomly assigned to receive ABBV-932 or Placebo in addition to their currently prescribed ADTs. There is 1 in 3 chance of participants assigned to Placebo. Approximately 315 adult participants with GAD and inadequate response to ADTs will be enrolled in approximately 50 sites in the United States and Puerto Rico. Participants will receive oral capsules of ABBV-932 or matching placebo in addition to their prescribed ADT for 6 weeks and then will be followed for an additional 4 week follow-up period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Вмешательства

• Препарат ABBV-932
  Oral Capsule
• Препарат Placebo for ABBV-932
  Oral Capsule
• Препарат Antidepressant Therapy (ADT)
  Standard of care

Первичные конечные точки

• Number of Participants with Adverse Events (AEs) [Срок оценки: Up to approximately 10 weeks]
• Change from Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score [Срок оценки: Up to approximately 6 weeks]

Вторичные конечные точки (11)

• Change from Baseline in Penn State Worry Questionnaire-10 (PSWQ-10) Total Score [Срок оценки: Up to approximately 6 weeks]
• Change from Baseline in Clinical Global Impression of Severity Scale (CGI-S) Generalized Anxiety Disorder (GAD) [Срок оценки: Up to approximately 6 weeks]
• Change from Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score [Срок оценки: Up to approximately 4 weeks]
• Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score [Срок оценки: Up to approximately 6 weeks]
• Percentage of Participants in Remission [Срок оценки: Up to approximately 6 weeks]
• Percentage of Participants with HAM-A Response [Срок оценки: Up to approximately 6 weeks]
• Percentage of Participants with Clinical Global Impression of Change (CGI-C) GAD Responder Status of "Much Better" or "Moderately Better" [Срок оценки: Up to approximately 6 weeks]
• Change from Baseline in Patient Global Impression of Severity Scale (PGI-S) Generalized Anxiety Disorder (GAD) [Срок оценки: Up to approximately 6 weeks]
• Percentage of Participants with Patient Global Impression of Change Scale (PGI-C) Generalized Anxiety Disorder (GAD) Responder Status of "Much Better" or "Moderately Better" [Срок оценки: Up to approximately 6 weeks]
• Change from Baseline in Patient Global Impression of Severity Scale (PGI-S) Worry [Срок оценки: Up to approximately 6 weeks]
• Percentage of Participants with Patient Global Impression of Change Scale (PGI-C) Worry Responder Status of "Much Better" or "Moderately Better" [Срок оценки: Up to approximately 6 weeks]

Критерии участия

Критерии включения

• Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for generalized anxiety disorder (GAD) confirmed by the Mini International Neuropsychiatric Interview (MINI).
• Currently taking protocol-specified antidepressant therapies (ADT) for GAD with an inadequate response to an adequate dose (per label) and duration (>= 8 weeks) as verified by a baseline Hamilton Anxiety Rating Scale (HAM-A) total score >= 20 and Clinical Global Impression of Severity Scale (CGI-S GAD) >= 4.

Критерии исключения

• Have a Montgomery-Åsberg Depression Rating Scale (MADRS) score >= 20.
• New diagnosis or exacerbation of major depression in the last 6 months.

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 · 49 центров

• University of Alabama - Huntsville Regional Medical Campus /ID# 267818 — Huntsville
• Ima Clinical Research Phoenix (Alea) /ID# 275737 — Phoenix
• Noble Clinical Research /ID# 267952 — Tucson
• Advanced Research Center /ID# 267874 — Anaheim
• Axiom Research /ID# 267814 — Colton
• Sun Valley Research Center /ID# 267864 — Imperial
• Synergy San Diego /ID# 267879 — Lemon Grove
• Alliance for Research Alliance for Wellness /ID# 267911 — Long Beach
• … и ещё 41 центр

Пуэрто-Рико · 3 центра

• Inspira Clinical Research /ID# 267822 — San Juan
• Instituto De Neurologia Dra. Ivonne Fraga, Psc /ID# 267793 — San Juan
• BDH Research /ID# 267787 — San Juan

Идентификаторы

NCT: NCT06846320 · M25-099

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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