CompletedPhase 2/3

Acute Anxiolytic Effects of Riluzole on Subjects With Social Anxiety Disorder

United States22 participantsStarted 2017-01

Plain-language summary

The goal of the current proposal is to examine if sublingual riluzole can reduce anxiety in people with social anxiety disorder during a public speaking task.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control, including complete abstinence, during the testing period) between the age of 18 and 65 yrs.
✓. Meet DSM-5 criteria for social anxiety disorder by structured clinical interview (SCID) and have a LSAS public speaking subscale score \>6.
✓. Stable psychiatric medications. Participants must have had stable doses of all psychiatric medications for the month prior to treatment and have been on stable doses of SSRI and antidepressants for at least 1 month prior to study enrollment. As needed benzodiazepine use will be permitted as long as subjects refrain from using benzodiazepines for the 48 hours prior to the study.
✓. Medically and neurologically healthy on the basis of physical examination, SMAC-20 (including LFT's, TFT's), VDRL, CBC w/ diff, urinalysis, urine toxicology, EKG, and medical history. Individuals with stable medical problems that do not have CNS effects or interfere with medications administered (e.g., oral hypoglycemics) may be included if their medications have not been adjusted in the month prior to entry;
✓. Urine toxicology screen negative for drug of abuse.
✓. Able to provide written informed consent according to the Yale Human Investigation Committee (HIC) guidelines.

Exclusion criteria

✕. Positive pregnancy test
✕. Breastfeeding females
✕. History of substance abuse disorder (ETOH, cocaine, opiates, PCP) within the last 6 months or positive urine toxicology on screening (within the previous 6 months).
✕. History of pervasive developmental disorder or psychotic disorder by DSM-IV-TR criteria.
✕. Presence of dentures, braces, piercings at the time of dosing, or any physical findings in the mouth or tongue that, in the opinion of the Principal Investigator, would be likely to interfere with successful completion of the dosing procedure.
✕. Participants with a medical condition that might interfere with the physiological absorption and motility (ie, gastric bypass, duodenectomy) or gastric bands.
✕. Participants with any clinically significant abnormality or abnormal laboratory test results.
✕. Participant has a current diagnosis of viral hepatitis (HBsAG or HVC) or a history of liver disease.

What they're measuring

VAS-anxiety Immediately After the Impromptu Speech Task

Timeframe: up to 60 minutes

Trial details

NCT IDNCT03017508

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12

Results submitted2021-03-09

View on ClinicalTrials.gov More Social Anxiety Disorder trials