What is the mechanism of action of this treatment?

Common treatments for conditions like Generalized Anxiety Disorder (GAD) and Bipolar Disorder (BPD) often target neurotransmitter systems such as serotonin, dopamine, and GABA. Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) increase the levels of serotonin and norepinephrine in the brain, which can help improve mood and reduce anxiety. Benzodiazepines enhance the effect of the neurotransmitter GABA, producing a calming effect. Mood stabilizers, such as lithium, help to balance neurotransmitter levels to prevent mood swings. Understanding these mechanisms is important for healthy subjects to be aware of potential side effects and the need for careful monitoring during treatment.

What side effects are associated with this type of intervention?

Common treatments for anxiety and mood regulation, such as fluoxetine, lithium, and clozapine, have a range of side effects. Fluoxetine, an SSRI, can cause nausea, insomnia, and sexual dysfunction. Lithium, a mood stabilizer, may lead to weight gain, tremors, and increased thirst. Clozapine, an antipsychotic, is associated with sedation, weight gain, and a risk of agranulocytosis. These treatments target neurotransmitter systems and pathways involved in mood regulation, similar to the investigational drug ABBV-932.

What prior FDA approvals exist?

FDA-approved treatments for conditions involving neurotransmitter systems or pathways related to anxiety and mood regulation include selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and sertraline, serotonin-norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine, and benzodiazepines like alprazolam and diazepam. For mood stabilization in bipolar disorder, lithium and anticonvulsants like valproate are commonly used. Additionally, second-generation antipsychotics such as aripiprazole and quetiapine are approved for both mood stabilization and augmentation in treatment-resistant depression.

What other types of research exist?

Promising novel alternatives to ABBV-932 for healthy subjects considering treatment in 2024 include: 1) Varenicline, which has shown efficacy and safety in smoking cessation and mood regulation in patients with psychiatric disorders. 2) Cannabidiol (CBD) and other cannabinoid-based treatments, which have demonstrated potential in managing anxiety and mood disorders. 3) Neuromodulation techniques such as vagus nerve stimulation (VNS) and deep brain stimulation (DBS), which have shown promise in treatment-resistant mood disorders. These alternatives target neurotransmitter systems and pathways involved in anxiety and mood regulation and have been supported by recent clinical trials.

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ABBV-932 for Generalized Anxiety Disorder

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

For healthy volunteer cohort: Individuals between 18 and 65 years of age inclusive at the time of screening.

For patients with generalized anxiety disorder (GAD) cohort(s): Patients with GAD between 18 and 65 years of age, inclusive at time of screening meet the following criteria: Patients with DSM-5 Primary diagnosis of GAD as confirmed by MINI, and a HAM-A score ≥ 15 (at least moderate anxiety) and CGI-Severity Score ≥ 3 (mildly ill) at screening.

Must not have

History of major depressive episode within the past 3-months.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to day 129

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions related to ABBV-932 compared to placebo which could range from mild discomforts like headaches or nausea to more serious conditions depending on individual responses.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 65 years old.

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had a major depressive episode in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to day 129

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to day 129

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 129 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 Plasma Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUCtau)

Maximum Observed Plasma Concentration (Cmax)

Number of Participants with Adverse Events (AEs)

+2 more

Trial Design

8Treatment groups

Experimental Treatment

Group I: Part D, Placebo for ABBV-932Experimental Treatment1 Intervention

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

Group II: Part D, ABBV-932Experimental Treatment1 Intervention

Participants will receive ABBV-932 QD for 42 days.

Group III: Part C, Placebo for ABBV-932Experimental Treatment1 Intervention

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

Group IV: Part C, ABBV-932Experimental Treatment1 Intervention

Participants will receive ABBV-932 QD for 28 days.

Group V: Part B, Placebo for ABBV-932Experimental Treatment1 Intervention

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

Group VI: Part B, ABBV-932Experimental Treatment1 Intervention

Participants will receive ABBV-932 QD for 28 days.

Group VII: Part A, Placebo for ABBV-932Experimental Treatment1 Intervention

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

Group VIII: Part A, ABBV-932Experimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ABBV-932

2023

Completed Phase 1

~110

0 / 3Eligibility 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

Common treatments for conditions like Generalized Anxiety Disorder (GAD) and Bipolar Disorder (BPD) often target neurotransmitter systems such as serotonin, dopamine, and GABA. Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) increase the levels of serotonin and norepinephrine in the brain, which can help improve mood and reduce anxiety. Benzodiazepines enhance the effect of the neurotransmitter GABA, producing a calming effect. Mood stabilizers, such as lithium, help to balance neurotransmitter levels to prevent mood swings. Understanding these mechanisms is important for healthy subjects to be aware of potential side effects and the need for careful monitoring during treatment.