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

AbbVie

Status and phase: Enrolling; Phase 2

Conditions: Generalized Anxiety Disorder (GAD)

Treatments: Drug: Antidepressant Therapy (ADT); Drug: ABBV-932; Drug: Placebo for ABBV-932

Study type: Interventional

Funder types: Industry

Identifiers

NCT06846320

M25-099

Details and patient eligibility

About

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.

Enrollment: 315 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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315 participants in 3 patient groups, including a placebo group

ABBV-932 Dose A

Experimental group

Description:

Participants will receive ABBV-932 dose A in addition to prescribed antidepressant therapies (ADTs).

Treatment:

Drug: ABBV-932

Drug: Antidepressant Therapy (ADT)

ABBV-932 Dose B

Experimental group

Description:

Participants will receive ABBV-932 dose B in addition to prescribed antidepressant therapies (ADTs).

Treatment:

Drug: ABBV-932

Drug: Antidepressant Therapy (ADT)

Placebo for ABBV-932

Placebo Comparator group

Description:

Participants will receive placebo for ABBV-932 in addition to prescribed antidepressant therapies (ADTs).

Treatment:

Drug: Placebo for ABBV-932

Drug: Antidepressant Therapy (ADT)