What prior FDA approvals exist?

<p>The FDA has approved several medications for the treatment of Generalized Anxiety Disorder (GAD), primarily focusing on Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs). Commonly approved SSRIs include paroxetine, sertraline, and escitalopram, while SNRIs such as venlafaxine and duloxetine are also widely used.</p> <p>These medications work by increasing the levels of serotonin and norepinephrine in the brain, which helps to alleviate anxiety symptoms.</p>

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SEP-363856 for Generalized Anxiety Disorder

Phase 2 & 3

Recruiting

Research Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.

Eligibility Criteria Checklist

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

Must have

Male or female subject between 18 to 65 years of age.

Subject meets DSM-5 criteria for a diagnosis of Generalized Anxiety Disorder.

Must not have

Have you taken any anticonvulsants, antipsychotics or mood stabilizers in the past 12 months?

Have you tried three or more antidepressant treatments before that were not effective enough?

Timeline

Screening 3 weeks

Treatment 8 weeks

Follow Up 1 weeks

Summary

This Phase 2/3 clinical trial is designed to evaluate SEP-363856 for Generalized Anxiety Disorder

Who is the study for?

This trial is for adults aged 18-65 with Generalized Anxiety Disorder who can follow the study's procedures for the following: Up to 3 weeks of screening, 8 weeks of treatment and 1 week follow up. Participants must have a BMI of 18-40.

What is being tested?

The trial is testing SEP-363856, a potential new treatment for Generalized Anxiety compared to a placebo.

What are the potential side effects?

While specific side effects aren't listed here, common side effects associated with anxiety medications may include dizziness, sleepiness, nausea, dry mouth, changes in appetite or weight. Individual experiences may vary.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 65 years old.

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I have been diagnosed with Generalized Anxiety Disorder.

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I have been diagnosed with or show symptoms of Generalized Anxiety Disorder.

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I have been diagnosed with or show symptoms of Generalized Anxiety Disorder.

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I am between 18 and 65 years old.

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I have been diagnosed with or show symptoms of Generalized Anxiety Disorder.

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I have never used ketamine, esketamine, arketamine, or psychedelic therapies.

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I haven't taken any anticonvulsants, antipsychotics, or mood stabilizers in the last year.

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I am between 18 and 65 years old.

Exclusion Criteria

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

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I have not taken anticonvulsants, antipsychotics, or mood stabilizers in the last year.

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I have tried three or more antidepressants without enough improvement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ 8 weeks8 visits

Follow Up ~ 1 weeks1 visit

Screening ~ 3 weeks

Treatment ~ 8 weeks

Follow Up ~1 weeks

This trial's timeline: 3 weeks for screening, 8 weeks for treatment, and 1 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Endpoint

Secondary study objectives

Change from Baseline in Clinical Global Impression-Severity (CGI-S) score at Endpoint

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SEP-363856Experimental Treatment1 Intervention

Tablet administered daily

Group II: PlaceboPlacebo Group1 Intervention

Tablet administered daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SEP-363856

2016

Completed Phase 3

~950

0 / 11Eligibility 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

Prior Approvals

Common treatments for Generalized Anxiety Disorder (GAD) primarily include Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs). SSRIs, such as paroxetine and sertraline, work by increasing serotonin levels in the brain, which helps improve mood and reduce anxiety. SNRIs, like venlafaxine and duloxetine, increase both serotonin and norepinephrine levels, providing a broader spectrum of mood stabilization. SEP-363856, a novel treatment under study, acts as a Trace Amine-Associated Receptor 1 (TAAR1) Agonist and Serotonin 5-HT1A Receptor Agonist. This dual mechanism can modulate neurotransmitter systems more precisely, potentially offering enhanced efficacy and safety for GAD patients.

Receptors of mammalian trace amines.