RECRUITING

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

Conditions

PTSD Glucocorticoids Posttraumatic Stress Disorder Quality of Life

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-10-15

Study Completion:2024-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04452500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 69 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Jennifer A Hlavin, MS

CONTACT

(415) 221-4810

jennifer.hlavin@va.gov

Stephanie Menjivar Quijano, BA

CONTACT

(415) 802-5308

stephanie.menjivarquijano@va.gov

Principal Investigator

Thomas C. Neylan, MD

PRINCIPAL_INVESTIGATOR

San Francisco VA Medical Center, San Francisco, CA

Study Locations (Sites)

Tuscaloosa VA Medical Center, Tuscaloosa, AL

Tuscaloosa, Alabama, 35404

United States

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121-1563

United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

Thomas C. Neylan, MD, PRINCIPAL_INVESTIGATOR, San Francisco VA Medical Center, San Francisco, CA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-15

Study Completion Date2024-12-31

Study Record Updates

Study Start Date2022-10-15

Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

Glucocorticoids
Posttraumatic Stress Disorder
Quality of Life

Additional Relevant MeSH Terms

PTSD