The Role of Orexin in Human Panic Disorder

NCT02593682 | Completed Phase 4 Results

• 1 other identifier: 2015078
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Panic Disorder

Outcome Measures

Primary Outcomes (4)

• Change in Orexin Levels (Blood) +1 Minute

  Change in orexin levels from baseline to +1 min post-CO2 challenge

  Baseline and +1 minute post-CO2 challenge

• Change in Orexin Levels (Blood) +5 Minutes

  Change in orexin levels from baseline to +5 min post-CO2 challenge

  Baseline and +5 minutes post-CO2 challenge

• Change in Orexin Levels (Blood) +15 Minutes

  Change in orexin levels from baseline to +15 min post-CO2 challenge

  Baseline and +15 minutes post-CO2 challenge

• Change in Orexin Levels (Blood) +60 Minutes

  Change in orexin levels from baseline to +60 min post-CO2 challenge

  Baseline and +60 minutes post-CO2 challenge

Study Arms (2)

Suvorexant Group

EXPERIMENTAL

In this arm, subjects will receive 10 mg suvorexant 2 hours before a one-minute 35% CO2 challenge.

Drug: suvorexant

Placebo Group

PLACEBO COMPARATOR

In this arm, subjects will receive a placebo, compounded to look identical to the study drug, 2 hours before a one-minute 35% CO2 challenge.

Drug: placebo

Interventions

suvorexant DRUG

Suvorexant Group

placebo DRUG

Placebo Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Fresno Medical Education Program

Fresno, California, 93701, United States

Location

Related Publications (43)

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MeSH Terms

Conditions

Panic Disorder

Interventions

suvorexant

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Andrew Goddard
• Organization: University of California, San Francisco

agoddard@fresno.ucsf.edu

(317) 274-3960

Study Officials

• Andrew Goddard, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2015
• First Posted: November 2, 2015
• Study Start: May 1, 2016
• Primary Completion: March 13, 2020
• Study Completion: March 13, 2020
• Last Updated: July 2, 2021
• Results First Posted: July 2, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)