ABBV-932 for Generalized Anxiety Disorder

(MAD Trial)

No longer recruiting at 4 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Disqualifiers: Significant illness, Infection, Hospitalization, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ABBV-932, a potential new drug, to evaluate its safety and behavior in the body. It focuses on individuals with Generalized Anxiety Disorder (GAD), bipolar disorder, and healthy participants. Participants will receive either ABBV-932 or a placebo for durations ranging from 14 to 42 days. This trial may suit those diagnosed with GAD or bipolar disorder who meet specific health criteria. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that ABBV-932 is likely to be safe for humans?

Research shows that ABBV-932 is under study to assess its safety and tolerability. In studies with healthy adults, researchers have tested different doses of ABBV-932 to understand its processing in the body. Some earlier reports examined potential side effects when combined with antidepressants for Generalized Anxiety Disorder (GAD).

Since ABBV-932 remains in early research stages, most safety information derives from these initial tests. Consequently, there is limited information on overall tolerability. However, testing in both healthy adults and those with GAD indicates that researchers closely monitor for any negative effects. Trials would not continue if it were unsafe.

Prospective trial participants should discuss potential risks and benefits with their doctor based on the available information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for anxiety?

Researchers are excited about ABBV-932 for generalized anxiety disorder because it offers a new approach compared to standard treatments like SSRIs and benzodiazepines. ABBV-932 is unique in its mechanism of action, potentially targeting different pathways in the brain associated with anxiety. This could mean fewer side effects or faster results than current medications, which can take weeks to become effective. Additionally, ABBV-932 is administered once daily, which may enhance patient compliance and convenience.

What evidence suggests that ABBV-932 might be an effective treatment for Generalized Anxiety Disorder?

Research suggests that ABBV-932 could help people with Generalized Anxiety Disorder (GAD) when added to their current antidepressant treatments. In other studies, people with GAD experienced reduced anxiety symptoms when ABBV-932 was combined with their usual medication. Although exact numbers from these studies are unavailable, the results indicate possible benefits for managing anxiety. In this trial, participants will receive either ABBV-932 or a placebo to assess the treatment's safety and effectiveness. Ongoing research aims to better understand its effects on anxiety disorders. More detailed findings will emerge as research progresses. ^{1 2 6 7 8}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for healthy adults, and patients with Generalized Anxiety Disorder (GAD) or Schizophrenia (SCZ), aged 18-65 with a BMI of 18.0 to 32.0 kg/m2. GAD patients must have moderate anxiety and be mildly ill at minimum. Exclusions include recent significant illness, hospitalization, surgery, major depression in the past 3 months, other psychiatric disorders besides GAD and MDD, or substance abuse within the last six months.

Inclusion Criteria

Body mass index (BMI) is >= 18.0 to <= 32.0 kg/m2 after rounding to the tenths decimal.

I am 18-65 with GAD, have moderate anxiety, and am at least mildly ill.

Exclusion Criteria

You have had a significant problem with drugs or alcohol in the past 6 months.

You have a history of certain mental health disorders, except for generalized anxiety disorder (GAD) and major depressive disorder (MDD).

I haven't had any serious illnesses, infections, fevers, hospital stays, or surgeries in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple ascending oral doses of ABBV-932 or placebo

6 weeks

Daily dosing

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-932
• Placebo for ABBV-932

Trial Overview The study tests ABBV-932 against a placebo to see how the body processes it and its safety profile when given multiple times orally to healthy individuals as well as those with GAD or SCZ.

How Is the Trial Designed?

Group I: Part D, Placebo for ABBV-932 Experimental Treatment 1 Intervention

Participants will receive placebo for ABBV-932 QD for 42 days.

Group II: Part D, ABBV-932 Experimental Treatment 1 Intervention

Participants will receive ABBV-932 QD for 42 days.

Group III: Part C, Placebo for ABBV-932 Experimental Treatment 1 Intervention

Participants will receive placebo for ABBV-932 QD for 28 days.

Group IV: Part C, ABBV-932 Experimental Treatment 1 Intervention

Participants will receive ABBV-932 QD for 28 days.

Group V: Part B, Placebo for ABBV-932 Experimental Treatment 1 Intervention

Participants will receive placebo for ABBV-932 QD for 28 days.

Group VI: Part B, ABBV-932 Experimental Treatment 1 Intervention

Participants will receive ABBV-932 QD for 28 days.

Group VII: Part A, Placebo for ABBV-932 Experimental Treatment 1 Intervention

Participants will receive placebo for ABBV-932 QD for 14 days.

Group VIII: Part A, ABBV-932 Experimental Treatment 1 Intervention

Participants will receive ABBV-932 once daily (QD) for 14 days.

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

Published Research Related to This Trial

In an 8-week study involving 266 adults with generalized anxiety disorder (GAD), tiagabine showed a significant reduction in anxiety symptoms compared to placebo in post hoc analyses, indicating its potential efficacy as a treatment option.

Tiagabine was generally well tolerated, with no significant adverse effects on sexual functioning or depressive symptoms, and no signs of discontinuation syndrome during tapering, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The selective GABA reuptake inhibitor tiagabine for the treatment of generalized anxiety disorder: results of a placebo-controlled study. Pollack, MH., Roy-Byrne, PP., Van Ameringen, M., et al.[2019]

The high placebo-response rate in clinical trials for generalized anxiety disorder has hindered the development of new treatments, with only one new anxiolytic approved by the FDA in the last 15 years.

The article reviews how the normalcy of anxiety and its sensitivity to life stresses complicate the ability to distinguish the actual effects of a drug from natural fluctuations in symptoms, making it challenging to demonstrate a drug's efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo response in generalized anxiety: its effect on the outcome of clinical trials. Schweizer, E., Rickels, K.[2007]

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. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M23-889

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.

8. clinicaltrial.be clinicaltrial.be/en/details/259144?per_page=100&only_recruiting=0&only_eligible=0

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. Trial design.