NCT05467683 CO2 Reactivity as a Biomarker of Non-Response to Exposure-Based Therapy
| NCT ID | NCT05467683 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Texas at Austin |
| Condition | Obsessive-Compulsive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2022-11-02 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 600 participants in total. It began in 2022-11-02 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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)
Contact & Investigator
Jasper Smits, Ph.D.
PRINCIPAL INVESTIGATOR
The University of Texas at Austin
Frequently Asked Questions
Who can join the NCT05467683 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Obsessive-Compulsive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05467683 currently recruiting?
Yes, NCT05467683 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Texas at Austin to inquire about joining.
Where is the NCT05467683 trial being conducted?
This trial is being conducted at Boston, United States, Austin, United States.
Who is sponsoring the NCT05467683 clinical trial?
NCT05467683 is sponsored by University of Texas at Austin. The principal investigator is Jasper Smits, Ph.D. at The University of Texas at Austin. The trial plans to enroll 600 participants.