ABBV-932 for Generalized Anxiety Disorder

Recruiting at 37 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AbbVie

Must be taking: Antidepressants

Disqualifiers: Major depression, others

Stay on Your Current Meds You can continue your current medications while participating

Prior Safety Data This treatment has passed at least one previous human trial

1 Power Preferred Clinic 1 of this trial's clinic is considered top 20 on Power

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

315 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of a new drug, ABBV-932, when added to current antidepressant treatments for individuals with generalized anxiety disorder (GAD) who haven't found success with antidepressants alone. Participants will receive either ABBV-932, a placebo, or different doses of ABBV-932 alongside their existing medication. The trial suits adults currently taking certain antidepressants, such as escitalopram or paroxetine, who still experience significant anxiety. Participants will take the trial medication for six weeks and visit a clinic regularly for health checks and to report their well-being. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in anxiety treatment.

Do I have to stop taking my current medications for the trial?

No, you will not have to stop taking your current medications. The trial involves adding the investigational drug ABBV-932 or a placebo to your existing antidepressant therapy.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ABBV-932 has been tested in healthy adults to assess its safety and tolerability. In these studies, participants received varying doses of ABBV-932 to observe their bodily responses. The results indicated that ABBV-932 was generally well-tolerated, with most participants not experiencing serious side effects.

The research also examined the drug's movement through the body, aiding in determining the optimal dose that is both effective and safe. Reports so far suggest that ABBV-932 does not cause major issues for those who take it.

Currently, ABBV-932 is being tested for safety in individuals with generalized anxiety disorder (GAD). This phase of testing typically indicates that the drug has shown sufficient promise in earlier research to warrant testing in a larger population. However, ongoing studies are crucial to confirm its safety and effectiveness when used alongside other antidepressant treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about ABBV-932 because it offers a new approach to treating Generalized Anxiety Disorder (GAD). Unlike traditional treatments like SSRIs or SNRIs, which work by altering serotonin and norepinephrine levels, ABBV-932 may target different pathways, potentially offering relief to those who don’t respond well to existing medications. ABBV-932 is being tested in two different doses (A and B), which adds a layer of flexibility and personalization in treatment options. Additionally, the inclusion of a placebo group helps ensure the results will clearly show the effectiveness of ABBV-932 when combined with standard antidepressant therapies.

What evidence suggests that ABBV-932 might be an effective treatment for generalized anxiety disorder?

Research shows that ABBV-932 might enhance the effects of standard antidepressant treatments for generalized anxiety disorder (GAD). Earlier studies examined the safety and pharmacokinetics of ABBV-932, yielding positive results in healthy adults. In this trial, participants will receive either varying doses of ABBV-932 or a placebo, alongside prescribed antidepressant therapies. Although direct evidence on its effectiveness for GAD is still being gathered, the drug aims to boost the efficacy of current treatments. The goal is to assist those who don't fully benefit from antidepressants alone. Early signs suggest it could be a valuable addition to existing GAD treatment options. ^{1 3 5 6 7}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

Adults with Generalized Anxiety Disorder (GAD) who haven't had enough relief from FDA-approved antidepressants like escitalopram or venlafaxine can join. They must have been on these meds for at least 8 weeks and still score high on anxiety scales.

Inclusion Criteria

Are you currently taking medication for depression but not getting the results you hoped for?

Exclusion Criteria

In the past 6 months, have you been treated by a doctor for depression?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral capsules of ABBV-932 or matching placebo in addition to their prescribed ADT

6 weeks

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-932

Trial Overview The trial tests if ABBV-932 helps when added to regular antidepressant therapy in GAD patients. Participants will either get ABBV-932 or a placebo alongside their current meds, chosen randomly, over a 6-week treatment period followed by 4 weeks of follow-up.

How Is the Trial Designed?

Group I: ABBV-932 Dose B Experimental Treatment 2 Interventions

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

Group II: ABBV-932 Dose A Experimental Treatment 2 Interventions

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

Group III: Placebo for ABBV-932 Placebo Group 2 Interventions

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

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05738850

Study to Assess Adverse Events and How ABBV-932 Oral ... The main objective of this study is to assess pharmacokinetics, safety, and tolerability of ABBV-932 in healthy adult participants. Official Title. Generalized ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06846320

NCT06846320 | Study to Assess Adverse Events and ... 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.

3. withpower.com withpower.com/trial/abbv-932-for-generalized-anxiety-disorder-fdc2b

ABBV-932 for Generalized Anxiety Disorder 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 ...

4. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M23-893

A Study to Evaluate the Pharmacokinetics, Safety, and ... The purpose of this study is to assess the pharmacokinetics, safety, and tolerability following multiple ascending oral doses of ABBV-932 or placebo in healthy ...

5. adaa.trialstoday.org adaa.trialstoday.org/trial/NCT06846320

Anxiety & Depression Association of America 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 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06024239

NCT06024239 | A Study to Evaluate the Pharmacokinetics, ... The purpose of this study is to assess the pharmacokinetics, safety, and tolerability following multiple ascending oral doses of ABBV-932 or placebo in healthy ...

7. ctv.veeva.com ctv.veeva.com/study/a-study-to-evaluate-adverse-events-abbv-932-and-how-oral-abbv-932-capsules-move-through-the-body-in

A Study to Evaluate the Pharmacokinetics, Safety, and ... The purpose of this study is to assess the pharmacokinetics, safety, and tolerability following multiple ascending oral doses of ABBV-932 or ...