What side effects are associated with this type of intervention?

Common treatments for PTSD include SSRIs (e.g., sertraline, paroxetine) and SNRIs (e.g., venlafaxine), which can cause side effects such as nausea, insomnia, sexual dysfunction, and increased anxiety. Prazosin, used for sleep disturbances and nightmares, may lead to dizziness and hypotension. Second-generation antipsychotics, often used for treatment-resistant cases, can cause weight gain, metabolic syndrome, and extrapyramidal symptoms. While brexanolone, a GABA-A receptor modulator, is still under study, similar agents may cause sedation, dizziness, and disorientation.

What prior FDA approvals exist?

The FDA has approved selective serotonin reuptake inhibitors (SSRIs) such as sertraline and paroxetine for the treatment of PTSD. These medications primarily work by increasing serotonin levels in the brain. While Brexanolone, which modulates GABA-A receptors, is being studied for its potential in treating PTSD, there are currently no FDA-approved treatments for PTSD that specifically target GABA-A receptor modulation. Most approved treatments focus on serotonin pathways rather than GABAergic systems.

What other types of research exist?

Promising novel alternatives to Brexanolone for PTSD treatment include MDMA-assisted therapy, which has shown significant efficacy in reducing PTSD symptoms in a randomized, double-blind, placebo-controlled phase 3 study, and stellate ganglion block, which has demonstrated effectiveness in randomized clinical trials. Additionally, propranolol therapy before reactivation of traumatic memories has shown potential in reducing PTSD symptoms.

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Neurosteroid

Brexanolone for PTSD

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

Common treatments for Post-Traumatic Stress Disorder (PTSD) include selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), which work by increasing the levels of serotonin and norepinephrine in the brain to improve mood and reduce anxiety. Another treatment, prazosin, an alpha-adrenergic receptor blocker, is used to reduce nightmares and improve sleep quality. Brexanolone, which modulates GABA-A receptors, enhances the inhibitory effects of GABA, the primary inhibitory neurotransmitter in the brain, potentially reducing hyperarousal and anxiety symptoms in PTSD. These mechanisms are crucial as they target the neurobiological disruptions in PTSD, helping to alleviate symptoms and improve overall functioning.

Phase 1

Recruiting

Led By MacKenzie R Peltier, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

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

Must have

Meet DSM-5 diagnostic criteria for PTSD in the past 6 months

Men: drink greater than 14 drinks per week and exceed five drinks per day at least once per week within the past 30 days

Must not have

Meets DSM-5 diagnostic criteria for schizophrenia, bipolar disorder, and/or other severe mental illnesses

Any significant current medical conditions (neurological, cardiovascular [including hypertension or hypotension: sitting BP >160/100 or <90/60mmHg at baseline screening], endocrine, thyroid, renal, liver), seizures, delirium or hallucinations, or other unstable medical conditions including HIV

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days following administration of brexanolone

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the safety and feasibility of using brexanolone, given through an IV, for people with both PTSD and AUD. The medication aims to balance brain chemicals to improve mood and reduce stress.

Who is the study for?

This trial is for adults aged 21-55 with PTSD and AUD who drink heavily but don't have severe mental illnesses, other substance use disorders (except tobacco), or are using psychoactive drugs. Pregnant/nursing women or those not on birth control are excluded, as well as anyone with serious health issues like heart problems, liver disease, seizures, or seeking AUD treatment.

What is being tested?

The study tests the safety and feasibility of Brexanolone in individuals with PTSD and AUD. It aims to see if this medication can reduce stress-induced alcohol consumption among men and women meeting specific drinking criteria related to their conditions.

What are the potential side effects?

While not explicitly listed here, potential side effects of Brexanolone may include dizziness, sleepiness, dry mouth or changes in mood. Participants will be monitored for any adverse reactions due to the drug's interaction with alcohol.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with PTSD in the last 6 months.

Select...

I am a man who drinks more than 14 times a week and has more than 5 drinks at least once a week.

Select...

I am a woman who drinks more than 7 times a week and exceeds 4 drinks at least once a week.

Select...

I am between 21 and 55 years old.

Exclusion Criteria

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

Select...

I have been diagnosed with schizophrenia, bipolar disorder, or another severe mental illness.

Select...

I do not have any major health issues like heart problems, kidney or liver disease, seizures, or HIV.

Select...

I have severe kidney disease or am taking opioids or drugs like Xanax.

Select...

I have used drugs for mental health, like anxiety or depression meds, in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days following administration of brexanolone

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days following administration of brexanolone

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days following administration of brexanolone for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Treatment-emergent adverse events

Side effects data

From 2021 Phase 3 trial • 28 Patients • NCT03665038

25%

Infusion site pain

13%

Sedation

13%

Nausea

13%

Upper respiratory tract infection

100%

80%

60%

40%

20%

Study treatment Arm

Double-Blind Phase: Placebo

Double-Blind Phase: Brexanolone

Open-Label Phase: Brexanolone

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: BrexanaoloneExperimental Treatment1 Intervention

In this single-arm study, participants will be administered brexanolone as a continuous IV infusion over 20 hours (titrated up to 90mcg/kg/hour).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Brexanolone

2018

Completed Phase 3

~50

0 / 8Eligibility 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 Post-Traumatic Stress Disorder (PTSD) include selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), which work by increasing the levels of serotonin and norepinephrine in the brain to improve mood and reduce anxiety. Another treatment, prazosin, an alpha-adrenergic receptor blocker, is used to reduce nightmares and improve sleep quality. Brexanolone, which modulates GABA-A receptors, enhances the inhibitory effects of GABA, the primary inhibitory neurotransmitter in the brain, potentially reducing hyperarousal and anxiety symptoms in PTSD. These mechanisms are crucial as they target the neurobiological disruptions in PTSD, helping to alleviate symptoms and improve overall functioning.

PTSD: from neurobiology to pharmacological treatments.