Phase 2 Study of ABBV-932 Added to Antidepressant Therapy for Adults with Generalized Anxiety Disorder Not Fully Responding to Current Treatment

What this Trial Is About

This research aims to evaluate the safety and effectiveness of ABBV-932 when added to antidepressant therapies ADTs in adults with generalized anxiety disorder GAD who have not adequately responded to ADTs alone. The study is a Phase 2, randomized, double-blind, placebo-controlled trial involving approximately 315 adult participants across about 50 sites in the United States and Puerto Rico. ABBV-932 is an investigational oral drug developed as an adjunct treatment for GAD. Participants will be randomly assigned to one of three groups two different doses of ABBV-932 added to their prescribed ADTs, or a placebo added to their ADTs. The treatment period lasts for 6 weeks, during which participants will take oral capsules of ABBV-932 or placebo alongside their ongoing antidepressant treatment. Following the treatment, there is a 4-week follow-up period to monitor outcomes and safety. During the study, participants will attend regular visits at hospitals or clinics where medical assessments, blood tests, side effect monitoring, and questionnaires will be conducted to evaluate the treatments impact. The main outcomes measured include the number of adverse events and changes in anxiety levels assessed by the Hamilton Anxiety Scale. Additional assessments include worry questionnaires and depression rating scales. The total participation time is approximately 10 weeks, covering treatment and follow-up.

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