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
- Conditions
- Generalized Anxiety Disorder (GAD)
- Interventions
- Registration Number
- NCT06846320
- Lead Sponsor
- AbbVie
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 315
- 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 one of the Food and Drug Administration (FDA) approved antidepressant therapies (ADT) for GAD (i.e., escitalopram, paroxetine, duloxetine, or venlafaxine ER) 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.
- Have a Montgomery-Åsberg Depression Rating Scale (MADRS) score >= 20.
- New diagnosis or exacerbation of major depression in the last 6 months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ABBV-932 Dose A Antidepressant Therapy (ADT) Participants will receive ABBV-932 dose A in addition to prescribed antidepressant therapies (ADTs). ABBV-932 Dose B Antidepressant Therapy (ADT) Participants will receive ABBV-932 dose B in addition to prescribed antidepressant therapies (ADTs). Placebo for ABBV-932 Placebo for ABBV-932 Participants will receive placebo for ABBV-932 in addition to prescribed antidepressant therapies (ADTs). Placebo for ABBV-932 Antidepressant Therapy (ADT) Participants will receive placebo for ABBV-932 in addition to prescribed antidepressant therapies (ADTs). ABBV-932 Dose A ABBV-932 Participants will receive ABBV-932 dose A in addition to prescribed antidepressant therapies (ADTs). ABBV-932 Dose B ABBV-932 Participants will receive ABBV-932 dose B in addition to prescribed antidepressant therapies (ADTs).
- Primary Outcome Measures
Name Time Method Number of Participants with Adverse Events (AEs) 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 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.
- Secondary Outcome Measures
Name Time Method Change from Baseline in Penn State Worry Questionnaire-10 (PSWQ-10) Total Score Up to approximately 6 weeks The PSWQ-10 is a 10-item, participant-reported measure of the tendency of an individual to worry, the excessiveness or intensity of worry, and the tendency for the worry to be generalized and not restricted to a small number of situations. Items are rated from 0 to 6 (0, never; 6, almost always). Total scores range from 0 to 60, with higher scores indicating greater worry.
Change from Baseline in Clinical Global Impression of Severity Scale (CGI-S) Generalized Anxiety Disorder (GAD) Up to approximately 6 weeks The CGI-S GAD is a single, clinician-reported item that measures the clinician's impression of a participant's current anxiety severity considering their total clinical experience with the participant population. The measure uses a 5-point Likert rating scale, with higher scores indicating greater anxiety severity.
Change from Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score Up to approximately 4 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.
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score Up to approximately 6 weeks The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants are rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.
Percentage of Participants in Remission Up to approximately 6 weeks Remission is defined as HAM-A total score \<=7.
Percentage of Participants with HAM-A Response Up to approximately 6 weeks HAM-A response is defined as \>= 50% reduction from baseline in HAM-A total score
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 The CGI-C GAD is a clinician-rated scale that measures the overall change in a participant's GAD symptoms since initial receipt of the study medication. The participant is rated on a 7-point Likert scale ranging from "Much better" (1) to "Much worse" (7).
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Trial Locations
- Locations (10)
Viking Clinical Research Center - Temecula /ID# 268598
🇺🇸Temecula, California, United States
Sunwise Clinical Research /ID# 267863
🇺🇸Walnut Creek, California, United States
Connecticut Clinical Research - Cromwell /ID# 271241
🇺🇸Cromwell, Connecticut, United States
Cns Healthcare - Jacksonville /ID# 268588
🇺🇸Jacksonville, Florida, United States
Accel Research Sites Network - St. Pete /ID# 267821
🇺🇸Largo, Florida, United States
GMI Florida - Central Miami Medical Institute /ID# 267839
🇺🇸Miami, Florida, United States
New Hope Clinical Research - Inpatient unit /ID# 267810
🇺🇸Charlotte, North Carolina, United States
Sooner Clinical Research /ID# 267881
🇺🇸Oklahoma City, Oklahoma, United States
Grayline Research Center /ID# 267811
🇺🇸Wichita Falls, Texas, United States
Northwest Clinical Research Center /ID# 267916
🇺🇸Bellevue, Washington, United States