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CO2 Reactivity as a Biomarker of Non-Response to Exposure-Based Therapy
RECRUITINGN/ASponsored by University of Texas at Austin
Actively Recruiting
PhaseN/A
SponsorUniversity of Texas at Austin
Started2022-11-02
Est. completion2026-12-01
Eligibility
Age18 Years – 70 Years
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →
NCT05467683
Summary
Anxiety-, obsessive-compulsive and trauma- and stressor-related disorders reflect a significant public health problem. This study is designed to evaluate the predictive power of a novel biomarker based on a CO2 challenge, thus addressing the central question "can this easy-to-administer assay aid clinicians in deciding whether or not to initiate exposure-based therapy?"
Eligibility
Age: 18 Years – 70 YearsHealthy volunteers accepted
Inclusion Criteria: * A primary DSM-5 diagnosis of panic disorder (with or without an agoraphobia diagnosis), social anxiety disorder, generalized anxiety disorder, obsessive-compulsive disorder, or post-traumatic stress disorder as assessed by the Structured Clinical Interview for the DSM-5 (SCID-5) * A score of 8 or greater on the Overall Anxiety Severity and Impairment Scale (OASIS) * Ages 18 to 70 * Willingness and ability to provide informed consent and comply with the requirements of the study protocol. * Proficiency in English (because assessment instruments have only been validated in English) Exclusion Criteria: * A lifetime history of bipolar or psychotic disorders, substance use disorders (other than nicotine) or eating disorder in the past 6 months; serious cognitive impairment. * Active suicidal ideation with at least some intent to act with or without specific plan (a rating of 4 for suicidal ideation on the Columbia-Suicide Severity Rating Scale) or suicidal behaviors (actual attempt, interrupted attempt, aborted or self-interrupted attempt, or preparatory acts or behavior) within the past 6 months. * Medical conditions contraindicating CO2 inhalation or hyperventilation challenge (e.g., cardiac arrhythmia, cardiac failure, asthma, lung fibrosis, high blood pressure, epilepsy, or stroke). * Pregnancy or lactation * Ongoing psychotherapy directed toward the primary disorder. * Pharmacological treatment started within 8 weeks prior to the screen (patients "stable" on their medication regimen will be included and their medication status will be included as a variable in the model)
Conditions6
AnxietyGeneralized Anxiety DisorderObsessive-compulsive DisorderPanic DisorderPost Traumatic Stress DisorderSocial Anxiety Disorder
Locations2 sites
Massachusetts
1 siteTexas
1 siteThe University of Texas at Austin
Austin, Texas, 78712
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Actively Recruiting
PhaseN/A
SponsorUniversity of Texas at Austin
Started2022-11-02
Est. completion2026-12-01
Eligibility
Age18 Years – 70 Years
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →
NCT05467683