Acute Anxiolytic Effects of Riluzole on Subjects With Social Anxiety Disorder

NCT03017508 | Completed Phase 2 Results

• 1 other identifier: 1605017768
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Social Anxiety Disorder; Performance Anxiety

Keywords

Cross-over study; Riluzole; Double-blind study; Speech task; Social Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• VAS-anxiety Immediately After the Impromptu Speech Task

  Measure Description: In the Visual Analogue Scale (VAS) participants are presented with a straight horizontal line of 100 mm in length and asked to mark the placement that would best describe the intensity of the anxiety felt at that moment. The left end (0mm) represents "no anxiety" and the right end (100mm) represents "the worst anxiety ever felt" by the participant.The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks, generating a numerical score along a continuum

  up to 60 minutes

Study Arms (2)

BHV-0223 (Sublingual Riluzole)

EXPERIMENTAL

Participants will be given one dose of BHV-0223 (sublingual riluzole) 35mg before performing a 10 minute speech task. Participants will then be assessed every hour for the next three hours. There will be 2 to 10 days of washout period between the randomly assigned arms of the study.

Drug: BHV-0223

Placebo

PLACEBO COMPARATOR

Participants will be given one dose of an identical looking sublingual placebo before performing a 10 minute speech task. Participants will then be assessed every hour for the next three hours. There will be 2 to 10 days of washout period between the randomly assigned arms of the study.

Drug: Placebo

Interventions

BHV-0223 DRUG

35mg of sublingual riluzole before performing an anxiety provoking speech task. Participants will then be clinically assessed every hour for 3 hours.

Also known as: sublingual riluzole

BHV-0223 (Sublingual Riluzole)

Placebo DRUG

a sublingual tablet identical to the active drug will be given before performing an anxiety provoking speech task. Participants will then be clinically assessed every hour for three hours.

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Participant has significant history of seizure disorder other than a single childhood febrile seizure (eg. Epilepsy)
• Participant using any drugs known to induce or inhibit CYP 1A2 metabolism (examples of inducers: rifampin, carbamazepine, etc.; examples of inhibitors: fluvoxamine, ciprofloxacin, fluoroquinolones, etc.) within 30 days prior to the first study drug administration.
• Participants with a history of allergic reactions to riluzole or other related drugs.
• Participant has a history of anaphylaxis, a documented hypersensitivity reaction, or a clinically important reaction to any drug.
• Participant has received another investigational drug or device within the 30 days (90 days for biologics) prior to the first dosing or is currently participating in an investigational study involving no drug administration.
• Participant with clinically significant electrocardiogram (ECG) abnormalities (QTcF \>450 msec) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at Screening or Baseline (Day -1).
• Any reason which, in the opinion of the Principal Investigator, would prevent the participant from being in the study.

Sponsors & Collaborators

• Yale University: lead
• Biohaven Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Connecticut Mental Health Center

New Haven, Connecticut, 06508, United States

Location

Related Publications (6)

• Davidson JR. Use of benzodiazepines in social anxiety disorder, generalized anxiety disorder, and posttraumatic stress disorder. J Clin Psychiatry. 2004;65 Suppl 5:29-33.

  PMID: 15078116 BACKGROUND

• Mathew SJ, Amiel JM, Coplan JD, Fitterling HA, Sackeim HA, Gorman JM. Open-label trial of riluzole in generalized anxiety disorder. Am J Psychiatry. 2005 Dec;162(12):2379-81. doi: 10.1176/appi.ajp.162.12.2379.

  PMID: 16330605 BACKGROUND

• Pittenger C, Coric V, Banasr M, Bloch M, Krystal JH, Sanacora G. Riluzole in the treatment of mood and anxiety disorders. CNS Drugs. 2008;22(9):761-86. doi: 10.2165/00023210-200822090-00004.

  PMID: 18698875 BACKGROUND

• Sanacora G, Kendell SF, Levin Y, Simen AA, Fenton LR, Coric V, Krystal JH. Preliminary evidence of riluzole efficacy in antidepressant-treated patients with residual depressive symptoms. Biol Psychiatry. 2007 Mar 15;61(6):822-5. doi: 10.1016/j.biopsych.2006.08.037. Epub 2006 Dec 4.

  PMID: 17141740 BACKGROUND

• Baker SL, Heinrichs N, Kim HJ, Hofmann SG. The liebowitz social anxiety scale as a self-report instrument: a preliminary psychometric analysis. Behav Res Ther. 2002 Jun;40(6):701-15. doi: 10.1016/s0005-7967(01)00060-2.

  PMID: 12051488 BACKGROUND

• Ries BJ, McNeil DW, Boone ML, Turk CL, Carter LE, Heimberg RG. Assessment of contemporary social phobia verbal report instruments. Behav Res Ther. 1998 Oct;36(10):983-94. doi: 10.1016/s0005-7967(98)00078-3.

  PMID: 9714948 BACKGROUND

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Results Point of Contact

• Title: Angeli Landeros
• Organization: Yale University

angeli.landeros@yale.edu

203-737-4809

Study Officials

• Michael H. Bloch, MD, MS

  Associate Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: January 11, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: January 29, 2021
• Last Updated: May 20, 2021
• Results First Posted: May 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)