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

Condition(s) studied

Investigational drug(s) / intervention(s)

ABBV-932: Oral Capsule

Placebo for ABBV-932: Oral Capsule

Antidepressant Therapy (ADT): Standard of care

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (52)

+ 12 more sites — see the full list on the official registry below.