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)

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• ABBV-932 — DRUG
  Oral Capsule
• Placebo for ABBV-932 — DRUG
  Oral Capsule
• Antidepressant Therapy (ADT) — DRUG
  Standard of care

Study Details

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.

Key Dates

Start date

Apr 29, 2025

Status verified

Jan 2026

Primary completion

Nov 30, 2026

Completion

Nov 30, 2026

Study Design

Enrollment

315 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: ABBV-932 Dose A
  Participants will receive ABBV-932 dose A in addition to prescribed antidepressant therapies (ADTs).
• Experimental: ABBV-932 Dose B
  Participants will receive ABBV-932 dose B in addition to prescribed antidepressant therapies (ADTs).
• Placebo Comparator: Placebo for ABBV-932
  Participants will receive placebo for ABBV-932 in addition to prescribed antidepressant therapies (ADTs).

Primary Outcome Measure

Number of Participants with Adverse Events (AEs) [ Time Frame: Up to approximately 10 weeks ]

Central Contacts

• ABBVIE CALL CENTER
  844-663-3742
  [email protected]

Locations (49)

Find similar trials in Huntsville, AL

Related Studies

• Targeting Social Function in Anxiety and Eating Disorders
  Recruiting · University of Texas Southwestern Medical Center · Dallas, Texas
• Assess the Utility of a Speech-based Machine Learning Algorithm to Predict Treatment Response to Psychiatric Interventions
  Enrolling By Invitation · Psyrin Inc. · Sunnyvale, California
• Comparative Effectiveness of Internet-based Versus Parent-Coached Cognitive-Behavioral Therapy For Children and Adolescents With Anxiety and OCD
  Recruiting · Baylor College of Medicine · Houston, Texas
• Stepped Care Treatment for Anxiety Resilience
  Recruiting · Andrew Wiese · Houston, Texas