What side effects are associated with this type of intervention?

Common treatments for PTSD include selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and second-generation antipsychotics (SGAs). SSRIs and SNRIs can cause side effects such as nausea, insomnia, sexual dysfunction, and weight gain. SGAs, like risperidone and quetiapine, may lead to weight gain, sedation, and metabolic syndrome. While cortisol blockers like CORT108297 are being studied, their side effects are not well-documented yet. However, potential side effects could include those related to hormonal imbalances, such as changes in mood, appetite, and sleep patterns.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Post-Traumatic Stress Disorder (PTSD), primarily focusing on selective serotonin reuptake inhibitors (SSRIs) such as sertraline and paroxetine. These medications help manage symptoms by influencing serotonin levels in the brain. While the trial of CORT108297, a cortisol blocker, is exploring a novel approach by targeting the stress hormone cortisol, there are no current FDA-approved treatments specifically targeting cortisol for PTSD. Other treatments, such as serotonin-norepinephrine reuptake inhibitors (SNRIs) and second-generation antipsychotics, are also used off-label for PTSD management.

What other types of research exist?

One promising alternative to CORT108297 for PTSD treatment is the use of histone deacetylase inhibitors like SAHA, which has shown efficacy in reducing ACTH secretion and may have potential benefits in PTSD by modulating stress hormone levels. Additionally, modified-release hydrocortisone, as studied in the DREAM trial, could be considered for its potential to entrain clock genes in immune cells, possibly offering benefits in stress-related disorders.

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Corticosteroid

Glucocorticoid Receptor Antagonist for PTSD (SEVEN Trial)

Phase 2

Recruiting

Led By Thomas C. Neylan, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

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

Must have

Participants (male or pre-menopausal females) agree to use two forms of reliable contraception, one of which is a barrier method

Chronic full syndromal PTSD diagnosis >3 months duration as indexed by CAPS-5 at screening, and CAPS-5 score > 26 CAPS-5 total score for the past week at baseline

Must not have

Chronic or unstable medical illness including unstable angina, myocardial infarction within the past 6 months, congestive heart failure, preexisting hypotension or orthostatic hypotension, heart block or arrhythmia, chronic renal or hepatic failure, and pancreatitis, severe chronic obstructive pulmonary disease, History of hepatobiliary disease or an AST or ALT greater than 2x the upper limit of normal, History of renal disease or an eGFR of less than 60 ml/min, A prolonged QTc >450 msec on ECG at screening, History of additional risk factors for Torsades de pointes, e.g., heart failure, hypokalemia, family history of long QT syndrome, Participants who may require the use of concomitant medications that prolong the QT/QTc interval, Use of concomitant medications that might increase the plasma concentration of CORT108297, e.g., use of strong inhibitors of CYP3A such as Clarithromycin, telithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir, Poorly controlled hypertension, Poorly controlled diabetes mellitus, History of moderate or severe traumatic brain injury, Mild cognitive impairment assessed by the Montreal Cognitive Assessment

Use of exclusionary antidepressant (mirtazapine, doxepin, tricyclics), mood stabilizers (e.g., lithium), antipsychotic medication, benzodiazepines

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 56 days

Summary

This trial tests a drug called CORT108297 that blocks the stress hormone cortisol to help Veterans with chronic PTSD. The study will check if the drug is safe and effective over a short period. Veterans will receive either the drug or an inactive substance, and their symptoms will be monitored regularly.

Who is the study for?

This trial is for US veterans with PTSD from military service, including combat or sexual trauma. They must have had symptoms for over 3 months and agree to use two forms of contraception if applicable. Participants can be on stable doses of certain medications like trazodone or SSRIs/SNRIs but not others that affect the study drug's metabolism or increase suicide risk.

What is being tested?

The trial is testing CORT108297, a new medication that blocks cortisol without affecting progesterone, which could help treat PTSD. It compares this drug to a placebo (a substance with no active drug). The goal is to see if it's effective and safe for treating PTSD in veterans.

What are the potential side effects?

While the specific side effects are not listed here, similar drugs often cause hormonal imbalances, mood changes, increased blood sugar levels, possible heart rhythm problems (due to QTc prolongation), and interactions with other medications.

Eligibility Criteria

Inclusion Criteria

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

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I agree to use two reliable birth control methods, including a barrier method.

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I have been diagnosed with PTSD for over 3 months and my recent CAPS-5 score is above 26.

Exclusion Criteria

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

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I am not taking certain antidepressants, mood stabilizers, antipsychotics, or benzodiazepines.

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I have a brain disorder or illness affecting my brain function.

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I have untreated sleep apnea or tested positive for it recently.

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I have not had serious thoughts or actions of harming myself or others in the last 3 months.

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I need to take corticosteroids for my medical condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 56 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~56 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 56 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

Clinician Administered PTSD Scale for DSM-5 (CAPS)

Frequency, Intensity, Burden of Side Effects (FIBSER)

Secondary study objectives

Columbia Suicide Severity Rating Scale

PTSD Checklist for DSM-5

World Health Organization Quality of Life (WHOQOL-BREF)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CORT108297Experimental Treatment1 Intervention

CORT108297- 180mg daily for 7 days

Group II: PlaceboPlacebo Group1 Intervention

Placebo- 180mg daily for 7 days

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 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 help regulate mood and anxiety. Another emerging treatment involves cortisol blockers like CORT108297, which aim to reduce the effects of cortisol, a stress hormone that is often elevated in PTSD patients. By blocking cortisol, these treatments may help reduce the hyperarousal and stress responses that are characteristic of PTSD. Understanding these mechanisms is crucial for tailoring treatments to individual patients, potentially improving outcomes by targeting the specific neurobiological pathways involved in PTSD.

Hydrocortisone administration for reducing post-traumatic stress symptoms: A systematic review and meta-analysis.