Phase IIa Trial of a Selective Glucocorticoid Receptor Antagonist in the Treatment of Veterans With Posttraumatic Stress Disorder (PTSD) (Seven Study)

PTSD Clinical Trial

— SEVEN  

Official title:

Phase IIa Trial of a Selective Glucocorticoid Receptor Antagonist in the Treatment of Veterans With Posttraumatic Stress Disorder (PTSD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04452500
• Other study ID #: MHBB-014-18S
• Secondary ID: CX001917-01
• Status: Recruiting
• Phase: Phase 2
• Start date: October 15, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: VA Office of Research and Development
• Contact: Jennifer A Hlavin, MS
• Phone: (415) 221-4810
• Email: jennifer.hlavin[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the drug CORT108297, which blocks the hormone cortisol, for treatment of PTSD in Veterans, and establish a safety profile that will inform the design of future studies.

Description:

This is a randomized, double-blind, placebo-controlled Phase IIa clinical trial to test the efficacy and safety of CORT108297- 180mg daily for 7 days for PTSD symptoms in Veterans. Each of the two sites will enroll 44 Veterans with chronic PTSD. Participants first will undergo screening procedures, including a clinical psychological interview, self-report questionnaires, blood draw, and medical evaluations. If eligible, they will be randomized to either CORT108297 or placebo. The same procedures will be repeated at several in-person and virtual visits before, during and after taking the study drug or placebo for seven days. The key outcome measures will be obtained at baseline, day 7, 28, and day 56.

There is large body of evidence demonstrating that Posttraumatic Stress Disorder (PTSD) is associated with alterations in the stress hormone cortisol. There is also evidence that medications that block cortisol may be beneficial for treating PTSD and depression. This study will test a medication, CORT108297, which is from a new class of cortisol blockers which have no effect on other hormones. CORT108297 has been shown to have efficacy in preclinical CNS models and was well tolerated and safe in Phase I healthy volunteer studies making it a candidate for further development. Thus, the goal will be to complete a Phase IIa proof of concept trial of CORT108297 to focus on safety and tolerability and obtain pilot efficacy data to inform the design of future clinical trials.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

Inclusion Criteria:

• History of US military service

• Capable of reading and understanding English

• Able to provide written informed consent

• Symptoms of PTSD (must score 23 or greater on the CAPS-5 assessment at screening visit)

• Men and pre-menopausal women must agree to use two forms of reliable contraception, one of which is a barrier method.

• Participants who use an SSRI or SNRI medication for PTSD must be on a stable dose for 8 weeks before enrollment.

• Participants who use trazodone for sleep must be on a stable dose.

• Participants who use opiate pain medication must be on a stable dose.

• For participants who are in psychotherapy, treatment must be stable for 6 weeks.

Exclusion Criteria:

• Alcohol use that meets criteria for Alcohol Use Disorder in past 3 months.

• Marijuana or other drug use that meets criteria for Substance Use Disorder in past 3 months.

• Ever diagnosed with: Bipolar Disorder, Schizophrenia, Schizoaffective Disorder, Obsessive-Compulsive Disorder, or Major Depressive Disorder with Psychotic Features

• Experienced any psychologically traumatic event in the past 3 months

• Currently using certain antidepressant medications such as doxepin or tricyclics

• Currently using certain mood stabilizers, such as lithium

• Currently using antipsychotic medication

• High risk for suicide or violent behavior

• Has sleep apnea and not using any treatment, such as CPAP

• Currently using corticosteroid medication (oral or inhaled)

• History of neurological disease

• Angina, congestive heart failure or low blood pressure

• Heart attack in the past 6 months

• Heart block or irregular heartbeat

• Kidney failure, liver failure or pancreatitis

• Severe chronic obstructive pulmonary disease (COPD)

• History of liver disease with lab results on AST or ALT more than 2 times the normal readings

• History of kidney disease with lab results on eGFR less than 60 ml/min

• History of additional risk factors for Torsades de pointes, such as heart failure, low potassium, or family history of a heart rhythm disorder called long QT syndrome

• Use of certain medications that can affect heart rhythm

• Use of certain medications that can interfere with the effects of the study drug

• High blood pressure that is not controlled by medication

• Diabetes that is not well-controlled

• History of certain types of head injuries

• Mild cognitive impairment

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• CORT108297
CORT108297- 180mg daily for 7 days
• Placebo
Placebo- 180mg daily for 7 days

Locations

Country	Name	City	State
United States	San Francisco VA Medical Center, San Francisco, CA	San Francisco	California
United States	Tuscaloosa VA Medical Center, Tuscaloosa, AL	Tuscaloosa	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Administered PTSD Scale for DSM-5 (CAPS)	The CAPS is a 30-item interview that is the gold standard assessment for PTSD. The CAPS provides a dimensional and categorical measure of PTSD, and incorporates frequency and intensity of symptoms into a single severity score.	56 days
Primary	Frequency, Intensity, Burden of Side Effects (FIBSER)	The FIBSER is a self-report 0-6 Likert-type scale that measures global frequency, intensity, and overall burden of side effects.	56 days
Secondary	Columbia Suicide Severity Rating Scale	The C-SSRS is FDA approved for assessing severity and change of suicidality in drug studies.	56 days
Secondary	PTSD Checklist for DSM-5	The PCL is a validated self-report scale assessing PTSD symptoms corresponding to DSM-5.	56 days
Secondary	World Health Organization Quality of Life (WHOQOL-BREF)	The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original WHOQOL-100 instrument and is more convenient for use in large research studies or clinical trials.	56 days