What side effects are associated with this type of intervention?

Common treatments for PTSD include Brexanolone, benzodiazepines, SSRIs, and SNRIs. Brexanolone and benzodiazepines, which modulate GABA-A receptors, can cause side effects such as sedation, dizziness, and potential dependence. SSRIs and SNRIs, which are often first-line treatments, may cause side effects like nausea, insomnia, sexual dysfunction, and weight gain. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of PTSD, primarily focusing on selective serotonin reuptake inhibitors (SSRIs) such as sertraline and paroxetine. These drugs work by increasing serotonin levels in the brain, which can help alleviate symptoms of PTSD. While brexanolone, a positive allosteric modulator of GABA-A receptors, is being studied for its potential benefits in PTSD, it is not yet FDA-approved for this indication. Other treatments under investigation include prazosin, an alpha-adrenergic receptor blocker, which has shown mixed results in clinical trials for reducing PTSD symptoms, particularly nightmares and sleep disturbances.

What other types of research exist?

Promising novel alternatives to Brexanolone for PTSD treatment include: 1) Allopregnanolone, another neurosteroid with anxiolytic effects through GABA-A receptor modulation. 2) Cannabinoids, which have shown some efficacy in reducing anxiety and PTSD symptoms. 3) SSRIs and SNRIs, which are well-established but continue to be refined and studied for PTSD. 4) Alpha-2 adrenergic agonists like clonidine, which may help with anxiety and hyperarousal symptoms. 5) Cognitive Behavioral Therapy (CBT) and other psychotherapeutic approaches, which remain critical components of PTSD treatment.

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Corticosteroid

Brexanolone for Post-Traumatic Stress Disorder

Phase 4

Recruiting

Led By Donald J Newport, MD

Research Sponsored by Donald Jeffrey Newport

Eligibility Criteria Checklist

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

Must have

Subject has a current diagnosis of PTSD associated with civilian trauma according to DSM-5 and confirmed by MINI at the screening visit

Subject is a premenopausal female between 18 and 50 years of age, inclusive

Must not have

History of seizure disorder

Previous treatment with specified medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study endpoint (week 12 / day 90)

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

This trial tests if an IV drip of brexanolone can reduce PTSD symptoms in adult women who have experienced non-military trauma. The study will also check the safety of the treatment and its effects on depression and daily functioning. Participants will be monitored closely throughout the process. Brexanolone is the first therapy approved by the US FDA for the treatment of postpartum depression (PPD) in adults.

Who is the study for?

This trial is for premenopausal women aged 18-50 with PTSD from civilian trauma, fluent in the test language, and in good health. Participants must not be pregnant or breastfeeding, have a stable psychotropic medication dose if any, and agree to use effective birth control during the study.

What is being tested?

The study tests Brexanolone Injection [Zulresso], given intravenously over 60 hours to see if it reduces PTSD symptoms severity based on PCL-5 scores and improves sleepiness and depression scales without causing significant side effects.

What are the potential side effects?

Potential side effects include changes in vital signs (like blood pressure), sleepiness as measured by the Stanford Sleepiness Scale, increased risk of suicidal thoughts assessed by Columbia Suicide Severity Rating Scale, and other adverse events that will be monitored.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with PTSD from a civilian trauma.

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I am a woman aged 18-50 and have not gone through menopause.

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I am in good health with normal physical exams, heart tests, and lab results.

Exclusion Criteria

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

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I have a history of seizures.

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I have taken specific medications before.

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I have kidney failure needing dialysis, severe liver failure, or low blood hemoglobin.

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I am allergic to certain hormone medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study endpoint (week 12 / day 90)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study endpoint (week 12 / day 90)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study endpoint (week 12 / day 90) 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 in PTSD Symptom Severity: PTSD Checklist for DSM-5 (PCL-5)

Secondary study objectives

Change in Depressive Symptoms: Montgomery-Asberg Depression Rating Scale (MADRS)

Change in Functional Capacity: Sheehan Disability Scale (SDS)

Change in PTSD Subscale Symptoms: PTSD Checklist for DSM-5 (PCL-5)

Other study objectives

Pulse Oximetry

Sedation: Stanford Sleepiness Scale (SSS)

Suicidal Ideation: Columbia Suicide Severity Rating Scale (C-SSRS)

Side effects data

From 2022 Phase 4 trial • 52 Patients • NCT05059600

12%

Fatigue

10%

Headache

Infusion site pain

Somnolence

100%

80%

60%

40%

20%

Study treatment Arm

ZULRESSO®

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

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

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Open-Label Infusion of BrexanoloneExperimental Treatment1 Intervention

This is a single arm pilot study of open label brexanolone delivered intravenously over a continuous 60-hour period. Infusions will be administered in a certified healthcare setting in accordance with the Zulresso™ dosing, administration and safety guidelines.

0 / 7Eligibility 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

Brexanolone, a positive allosteric modulator of GABA-A receptors, enhances the inhibitory effects of GABA, the primary inhibitory neurotransmitter in the brain, which can help reduce the hyperarousal and anxiety symptoms associated with PTSD. This mechanism is crucial for PTSD patients as it directly targets the heightened state of arousal and stress response. Other common treatments include SSRIs and SNRIs, which work by increasing the levels of serotonin and norepinephrine in the brain, respectively. These neurotransmitters are involved in mood regulation and can help alleviate the depressive and anxiety symptoms of PTSD. Understanding these mechanisms is important for tailoring treatment to individual patient needs and improving overall symptom management.