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

Launched by ABBVIE · Feb 21, 2025

Keywords

ClinConnect Summary

This clinical trial is examining how safe and effective a new medication called ABBV-932 is when added to existing antidepressant treatments for adults with Generalized Anxiety Disorder (GAD). Sometimes, antidepressants alone do not fully help those struggling with GAD, so this study aims to see if ABBV-932 can improve their condition. Adults aged 18 to 65 who have not responded well to their current antidepressants, like escitalopram or duloxetine, may be eligible to participate.

Participants in the trial will be randomly assigned to receive either ABBV-932 or a placebo (a sugar pill that looks like the actual medication) along with their current antidepressant for six weeks. They will attend regular visits to a clinic or hospital for check-ups, which will include assessments, blood tests, and questionnaires to monitor their progress and any side effects. After the six weeks, there will be an additional four-week follow-up period. It's important to note that this trial may require more visits and monitoring compared to standard treatment, but it could provide valuable information for improving anxiety treatment in the future.

Gender

ALL

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