Phase 4
Completed N=3
The Role of Orexin in Human Panic Disorder
Source: ClinicalTrials.gov NCT02593682 ↗Enrolled (actual)
3
Serious AEs
—
Results posted
Jul 2021
Primary outcomePrimary: Change in Orexin Levels (Blood) +1 Minute
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to provide some information (pilot data) about whether the study drug, suvorexant, (1) affects levels of orexin in people with panic disorder, and (2) is associated with decreased panic symptoms in response to a carbon dioxide (CO2) challenge.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Orexin Levels (Blood) +1 Minute |
— | — |
| PRIMARY Change in Orexin Levels (Blood) +5 Minutes |
— | — |
| PRIMARY Change in Orexin Levels (Blood) +15 Minutes |
— | — |
| PRIMARY Change in Orexin Levels (Blood) +60 Minutes |
— | — |
Eligibility Criteria
Inclusion Criteria
- They must be in stable physical health as determined by a medical evaluation, including physical examination, electrocardiogram, laboratory findings (comprehensive metabolic panel, complete blood count [CBC], free T4, urine pregnancy test, urinalysis), urine toxicology screen, and a negative urine pregnancy test in women of child-bearing potential.
- They must satisfy the new clinical criteria in the Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM-5) for a current principal diagnosis of PD as confirmed by a semi-structured, diagnostic interview, the Mini International Neuropsychiatric Interview (MINI), administered by the PI.
- Since clinical depression (MDD) is associated with CSF ORX abnormalities, only patients with a current PD without MDD will be enrolled. They will also be required to have a current Montgomery-Asberg Depression Rating Scale (MADRS) total score 12 on the Montgomery-Asberg Depression Rating Scale (MADRS)
- inability or unwillingness to avoid drinking grapefruit juice for two weeks prior to the 35% CO2 challenge test
- a history of sudden onset of muscle weakness (cataplexy)
Data sourced from ClinicalTrials.gov (NCT02593682). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.