The Role of Orexin in Human Panic Disorder

• Status: Completed
• Trial end date: 2020-03-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Suvorexant

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.

• They will be off all regular psychiatric medications and avoid drinking grapefruit juice for at least 2 weeks prior to the 35% CO2 test.

• They must not be pregnant or breastfeeding a baby; and women of childbearing potential must be using birth control while on this study.

Exclusion Criteria:

• any history of a psychotic disorder, bipolar disorder, MDD, depression not otherwise specified (NOS), obsessive compulsive disorder, an eating disorder, post-traumatic stress disorder, or generalized anxiety disorder

• medical conditions for which suvorexant could be contraindicated, such as narcolepsy

• any other sleep disorder

• a substance use disorder, as defined by the DSM-5, within 6 months of the screening visit

• ongoing use of psychiatric medications in the 2 weeks prior to the 35% CO2 test

• current use of certain drugs, including

• strong cytochrome P450 3A (CYP3A) inhibitors (such as ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin, and conivaptan);

• moderate CYP3A inhibitors (such as amprenavir, aprepitant, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil);

• strong CYP3A inducers (such as rifampin, carbamazepine and phenytoin);

• digoxin

• history of any neurological disorder affecting the CNS

• history of uncontrolled or serious medical illness

• a history of hypersensitivity or allergy to suvorexant

• pregnancy or lactation status, or unwillingness to use birth control while on this study, for women of child-bearing potential

• compromised lung function (e.g., chronic obstructive pulmonary disease [COPD], emphysema, idiopathic pulmonary fibrosis, lung cancer)

• inability to fast the required amount of time prior to study visit 2

• a positive test for cannabinoids, opiates, benzodiazepines, amphetamines, cocaine and metabolites

• out-of-range lab values

• an abnormal EKG

• a 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)