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Completed
NCT04029740
Exosomal microRNAs as a Biomarker in Panic Disorder and in Response to CBT
Conditions: Panic Disorder
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 52
Sponsor: Hebrew University of Jerusalem
Location: Hebrew University of Jerusalem Jerusalem Israel
Summary
Cognitive behavior therapy (CBT) has long been known as an effective treatment for anxiety disorders, either when given by a therapist or when self-administered through a computer program. However, the biological effect of CBT remained largely unexplored. Most studies focused on genomic differences and pursued differences in methylation patterns following CBT, but the findings were very limited in scope, especially when comparing responders and non-responders to CBT. In the currently proposed study, the investigators plan to go one step further and look for changes in exosomal microRNAs (miRs) from serum samples taken before and after CBT from Panic Disorder (PD) patients. Notably, miR changes show a much faster biological response than methylation patterns yet had never been used before in PD research. The primary benefit of this work will be in providing biological validation to psychological treatments. PD is a heavy public health burden, associated with significant market potential for both therapeutic and diagnostic uses.
Eligibility Criteria
Inclusion Criteria:
* Principal DSM-5 primary diagnosis of panic disorder and/or agoraphobia.
* Aged 18 years or older.
* PD duration of at least 3 months.
* If participant is on on medications for PD, the dosage has to remain constant for 3 months prior to the start of treatment and cannot be increased during treatment.
* The participant must have access to the internet and be willing to use it.
Exclusion Criteria:
* Substance abuse or dependence within the last 6 months.
* Active suicide potential within the last 6 months.
* Any current or history of psychosis or bipolar I disorder.
* Currently in weekly or biweekly psychotherapy.
* History of a complete course of panic focused CBT
Source: ClinicalTrials.gov (NCT04029740). StuddyBuddy aggregates publicly available trial information.