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The Role of Orexin in Human Panic Disorder

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ClinicalTrials.gov Identifier: NCT02593682
Recruitment Status : Active, not recruiting
First Posted : November 2, 2015
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Panic Disorder Drug: suvorexant Drug: placebo Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Role of Orexin in Human Panic Disorder
Actual Study Start Date : May 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Panic Disorder
Drug Information available for: Suvorexant

Arm Intervention/treatment
Experimental: Suvorexant Group
In this arm, subjects will receive 10 mg suvorexant 2 hours before a one-minute 35% CO2 challenge.
Drug: suvorexant
Placebo Comparator: Placebo Group
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



Primary Outcome Measures :
  1. Change in orexin levels (blood) +1 minute [ Time Frame: Baseline and +1 minute post-CO2 challenge ]
    Change in orexin levels from baseline to +1 min post-CO2 challenge

  2. Change in orexin levels (blood) +5 minutes [ Time Frame: Baseline and +5 minutes post-CO2 challenge ]
    Change in orexin levels from baseline to +5 min post-CO2 challenge

  3. Change in orexin levels (blood) +15 minutes [ Time Frame: Baseline and +15 minutes post-CO2 challenge ]
    Change in orexin levels from baseline to +15 min post-CO2 challenge

  4. Change in orexin levels (blood) +60 minutes [ Time Frame: Baseline and +60 minutes post-CO2 challenge ]
    Change in orexin levels from baseline to +60 min post-CO2 challenge



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02593682


Locations
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United States, California
UCSF Fresno Medical Education Program
Fresno, California, United States, 93701
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Andrew Goddard, MD University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:

Publications:
Samson WK, et al. Both type 1 and type 2 receptors transmit the behavioral effects of orexin/hypocretin. The FASEB Journal. 2007;21(5):A462.
Levine L, Gaydos B, Sheehan D, et al. The mGlu2/3 receptor agonist, LY354740, reduces panic anxiety induced by a CO2 challenge in patients diagnosed wityh panic disorder. Neuropharmacology. 2002;43(2):294.

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02593682     History of Changes
Other Study ID Numbers: 2015078
First Posted: November 2, 2015    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Disease
Panic Disorder
Pathologic Processes
Anxiety Disorders
Mental Disorders
Suvorexant
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Orexin Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action