What side effects are associated with this type of intervention?

Common treatments for Generalized Anxiety Disorder (GAD) include benzodiazepines, SSRIs, SNRIs, and other anxiolytics. Benzodiazepines can cause sedation, dizziness, and dependency. SSRIs and SNRIs may lead to nausea, insomnia, sexual dysfunction, and initially increased anxiety. Gabapentin, another anxiolytic, can cause dizziness, fatigue, and mood changes. These side effects vary among individuals.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Generalized Anxiety Disorder (GAD), primarily focusing on Selective Serotonin Reuptake Inhibitors (SSRIs) such as sertraline, paroxetine, and escitalopram, and Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) like venlafaxine and duloxetine. These medications are preferred due to their efficacy and safety profiles. Other approved treatments include benzodiazepines for short-term relief and buspirone for long-term management. The trial ABBV-932, which assesses pharmacokinetics, safety, and tolerability, suggests it may be exploring a new or investigational drug within this therapeutic landscape.

What other types of research exist?

Based on the provided context, no specific alternatives to ABBV-932 for Generalized Anxiety Disorder (GAD) are mentioned. However, compounds like 3-Aryl-1,2,4-oxadiazole derivatives, which show low systemic clearance and modest oral bioavailability, and Ewha-18278, which can be delivered both intravenously and orally, may be worth exploring further for their potential in treating GAD. Consultation with a healthcare provider is recommended to discuss these and other emerging treatments.

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ABBV-932 for Healthy Subjects

Q: What is the mechanism of action of this treatment?

The most common treatments for Generalized Anxiety Disorder (GAD) include SSRIs (Selective Serotonin Reuptake Inhibitors) and SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors), which work by increasing the levels of serotonin and norepinephrine in the brain, thereby improving mood and reducing anxiety. Buspirone acts as a partial agonist at serotonin (5-HT1A) receptors, helping to alleviate anxiety without the sedative effects associated with benzodiazepines. Gabapentin and pregabalin, which are often used as adjunctive treatments, modulate the release of excitatory neurotransmitters by binding to voltage-gated calcium channels. Understanding these mechanisms is crucial for GAD patients as it helps in selecting the most appropriate treatment based on their specific symptoms and response to previous medications.

Phase 1

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Parts 1 and 2: Healthy individuals with body-mass index (BMI) >= 18.0 to <= 32.0 kg/m2, rounded to the tenths decimal.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 5 days

Awards & highlights

Summary

This trial tests a new drug called ABBV-932 in healthy adults to see how it moves through the body and if it is safe.

Who is the study for?

This trial is for healthy adults, including Japanese and Han Chinese individuals with a BMI between 18.0 to 32.0 kg/m2. Participants must be in good health based on medical history, physical exams, lab tests, neurological exams, and ECG results. Those who've had significant illness or surgery within the last 30 days cannot join.

What is being tested?

The study is testing ABBV-932 oral capsules to see how they're processed by the body (pharmacokinetics) and to check their safety and tolerability compared to a placebo (a pill without active medication).

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions that may arise from taking ABBV-932 as it's being tested for safety and tolerability.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am healthy with a BMI between 18.0 and 32.0.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 5 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 5 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-932

Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of DCAR

Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of DDCAR

+15 more

Trial Design

7Treatment groups

Experimental Treatment

Placebo Group

Group I: Part 3: Japanese Participants: ABBV-932Experimental Treatment1 Intervention

Japanese participants will receive ABBV-932 on Day 1 in Period 1 and followed for 30 days.

Group II: Part 3: Han-Chinese Participants: ABBV-932Experimental Treatment1 Intervention

Han-Chinese participants will receive placebo on Day 1 in Period 1 and followed for 30 days.

Group III: Part 2: Sequence 2Experimental Treatment1 Intervention

Participants will receive ABBV-932 with food on Day 1 in Period 1 and followed for 30 days. Participants will receive ABBV-932 on Day 1 in Period 2 under fasting conditions and followed for 30 days.

Group IV: Part 2: Sequence 1Experimental Treatment1 Intervention

Participants will receive ABBV-932 on Day 1 in Period 1 under fasting conditions and followed for 30 days. Participants will receive ABBV-932 with food on Day 1 in Period 2 and followed for 30 days.

Group V: Part 1: ABBV-932Experimental Treatment1 Intervention

Participants will receive ABBV-932 on Day 1 and followed for 30 days.

Group VI: Part 3: Japanese Participants: PlaceboPlacebo Group1 Intervention

Japanese participants will receive placebo on Day 1 in Period 1 and followed for 30 days.

Group VII: Part 1: PlaceboPlacebo Group1 Intervention

Participants will receive placebo on Day 1 and followed for 30 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ABBV-932

2023

Completed Phase 1

~110

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Generalized Anxiety Disorder (GAD) include SSRIs (Selective Serotonin Reuptake Inhibitors) and SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors), which work by increasing the levels of serotonin and norepinephrine in the brain, thereby improving mood and reducing anxiety. Buspirone acts as a partial agonist at serotonin (5-HT1A) receptors, helping to alleviate anxiety without the sedative effects associated with benzodiazepines. Gabapentin and pregabalin, which are often used as adjunctive treatments, modulate the release of excitatory neurotransmitters by binding to voltage-gated calcium channels. Understanding these mechanisms is crucial for GAD patients as it helps in selecting the most appropriate treatment based on their specific symptoms and response to previous medications.