ABBV-932 for Generalized Anxiety Disorder

(MAD Trial)

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

72 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new medication called ABBV-932 to see how it works in the body and if it is safe for healthy adults and those with anxiety or bipolar disorder.

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.

What evidence supports the effectiveness of the drug ABBV-932 for treating generalized anxiety disorder?

The research highlights that new drugs targeting GABA receptors, like ABBV-932, may offer better effectiveness with fewer side effects compared to traditional treatments for generalized anxiety disorder. However, more clinical trials are needed to confirm these findings. ^{1 2 3 4 5}

How does the drug ABBV-932 differ from other treatments for generalized anxiety disorder?

The drug ABBV-932 may offer a novel approach to treating generalized anxiety disorder by potentially targeting specific receptors or pathways that differ from traditional treatments like benzodiazepines or antidepressants, which often have side effects such as drowsiness or weight gain. However, the exact mechanism and benefits of ABBV-932 compared to existing treatments are not detailed in the available research. ^{1 2 5 6 7}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. France pubmed.ncbi.nlm.nih.gov

[Treatment of generalized anxiety: new pharmacologic approaches]. [2007]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of treatments for refractory generalized anxiety disorder: a systematic review. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

The selective GABA reuptake inhibitor tiagabine for the treatment of generalized anxiety disorder: results of a placebo-controlled study. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

How well do randomized controlled trial data generalize to 'real-world' clinical practice settings? A comparison of two generalized anxiety disorder studies. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Placebo response in generalized anxiety: its effect on the outcome of clinical trials. [2007]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Pharmacotherapy in Generalized Anxiety Disorder: Novel Experimental Medicine Models and Emerging Drug Targets. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Galphimine-B Standardized Extract versus Alprazolam in Patients with Generalized Anxiety Disorder: A Ten-Week, Double-Blind, Randomized Clinical Trial. [2020]