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
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
315 (estimated)
Sponsor
AbbVie · Industry
Who this trial is looking for
This trial is looking for adults with generalized anxiety disorder (GAD) who have not had enough relief from their current antidepressant medications. Participants will take capsules of either ABBV-932 or a placebo for 6 weeks, along with their existing treatment, and attend regular check-up visits to monitor their progress.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with generalized anxiety disorder.
I am currently taking specific antidepressant medications for GAD.
My current treatment for GAD has not worked well enough for me.
I have scored 20 or higher on the Hamilton Anxiety Rating Scale.
I have scored 4 or higher on the Clinical Global Impression of Severity Scale.
You may not be able to join if
I have a score of 20 or higher on the Montgomery-Åsberg Depression Rating Scale.
I have been diagnosed with major depression in the last 6 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 develope…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 thera…
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Have a Montgomery-Åsberg Depression Rating Scale (MADRS) score \>= 20.
* New diagnosis or exacerbation of major depression in the last 6 months.
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