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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 315
- 试验地点
- 100
- 主要终点
- Number of Participants with Adverse Events (AEs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Have a Montgomery-Åsberg Depression Rating Scale (MADRS) score >=
- •New diagnosis or exacerbation of major depression in the last 6 months.
研究组 & 干预措施
Placebo for ABBV-932
Participants will receive placebo for ABBV-932 in addition to prescribed antidepressant therapies (ADTs).
干预措施: Placebo for ABBV-932 (Drug)
Placebo for ABBV-932
Participants will receive placebo for ABBV-932 in addition to prescribed antidepressant therapies (ADTs).
干预措施: Antidepressant Therapy (ADT) (Drug)
ABBV-932 Dose A
Participants will receive ABBV-932 dose A in addition to prescribed antidepressant therapies (ADTs).
干预措施: ABBV-932 (Drug)
ABBV-932 Dose A
Participants will receive ABBV-932 dose A in addition to prescribed antidepressant therapies (ADTs).
干预措施: Antidepressant Therapy (ADT) (Drug)
ABBV-932 Dose B
Participants will receive ABBV-932 dose B in addition to prescribed antidepressant therapies (ADTs).
干预措施: Antidepressant Therapy (ADT) (Drug)
ABBV-932 Dose B
Participants will receive ABBV-932 dose B in addition to prescribed antidepressant therapies (ADTs).
干预措施: ABBV-932 (Drug)
结局指标
主要结局
Number of Participants with Adverse Events (AEs)
时间窗: Up to approximately 10 weeks
An AE is defined as any untoward medical occurrence in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Change from Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score
时间窗: Up to approximately 6 weeks
The HAM-A is a 14-item, clinician-reported measure used to quantify and categorize the participant's anxiety over the past week. Items are rated on a 5-point Likert rating scale. The HAM-A total score ranges from 0 to 56, with higher scores indicating greater anxiety severity.
次要结局
- Change from Baseline in Penn State Worry Questionnaire-10 (PSWQ-10) Total Score(Up to approximately 6 weeks)
- Change from Baseline in Clinical Global Impression of Severity Scale (CGI-S) Generalized Anxiety Disorder (GAD)(Up to approximately 6 weeks)
- Change from Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score(Up to approximately 4 weeks)
- Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score(Up to approximately 6 weeks)
- Percentage of Participants in Remission(Up to approximately 6 weeks)
- Percentage of Participants with HAM-A Response(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"(Up to approximately 6 weeks)
- Change from Baseline in Penn State Worry Questionnaire-10 (PSWQ-10) Total Score(Up to approximately 6 weeks)
- Change from Baseline in Clinical Global Impression of Severity Scale (CGI-S) Generalized Anxiety Disorder (GAD)(Up to approximately 6 weeks)
- Change from Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score(Up to approximately 4 weeks)
- Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score(Up to approximately 6 weeks)
- Percentage of Participants in Remission(Up to approximately 6 weeks)
- Percentage of Participants with HAM-A Response(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"(Up to approximately 6 weeks)
- Change from Baseline in Patient Global Impression of Severity Scale (PGI-S) Generalized Anxiety Disorder (GAD)(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"(Up to approximately 6 weeks)
- Change from Baseline in Patient Global Impression of Severity Scale (PGI-S) Worry(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"(Up to approximately 6 weeks)