Acute Anxiolytic Effects of Riluzole on Subjects With Social Anxiety Disorder
Double-Blind, Placebo-Controlled, Single-Dose Crossover Study Examining the Effects of Sublingual Riluzole (BHV-0223) on Public Speaking in Social Anxiety Disorder
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06508
- Connecticut Mental Health Center
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: BHV-0223 (Sublingual Riluzole)
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.
|
35mg of sublingual riluzole before performing an anxiety provoking speech task.
Participants will then be clinically assessed every hour for 3 hours.
Other Names:
|
|
Placebo Comparator: Placebo
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VAS-anxiety Immediately After the Impromptu Speech Task
Time Frame: up to 60 minutes
|
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
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Michael H. Bloch, MD, MS, Associate professor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Phobic Disorders
- Disease
- Anxiety Disorders
- Phobia, Social
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Neuroprotective Agents
- Protective Agents
- Anticonvulsants
- Riluzole
Other Study ID Numbers
Other Study ID Numbers
- 1605017768
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Social Anxiety Disorder
-
NCT05987969CompletedSocial Anxiety | Social Anxiety Disorder | Social Anxiety Disorder (Social Phobia)
-
NCT05018260CompletedSocial Anxiety | Social Anxiety Disorder | Social Anxiety Disorder (Social Phobia)
-
NCT04879641CompletedSocial Anxiety Disorder (Social Phobia)
-
NCT06876779Not yet recruitingSocial Phobia | Social Anxiety Disorder (SAD)
-
NCT05858294CompletedSocial Anxiety | Social Anxiety Disorder | Social Anxiety Disorder (Social Phobia)
-
NCT03078270TerminatedAnxiety | Anxiety Disorder Social
-
NCT03135990TerminatedSocial Anxiety | Social Anxiety Disorder | Social Anxiety Disorder of Childhood
-
NCT03249116CompletedSocial Anxiety | Social Anxiety Disorder | Social Anxiety Disorder of Childhood
-
NCT06805565Active, not recruitingSocial Anxiety Disorder (SAD)
-
NCT06037668Completed
Clinical Trials on BHV-0223
-
NCT03520517CompletedAmyotrophic Lateral Sclerosis | ALS | Lou Gehrig Disease | Lou Gehrig's Disease | Lou-Gehrigs Disease | Motor Neuron Disease, Amyotrophic Lateral Sclerosis
-
NCT06425159Terminated
-
NCT04708834TerminatedObsessive Compulsive Disorder
-
NCT03266588CompletedMigraine, With or Without Aura
-
NCT06132893Recruiting
-
NCT06603623Completed
-
NCT07262268Enrolling by invitationFamilial Erythromelalgia
-
NCT03732638Completed