Randomized Trial of Adult Participants With Generalized Anxiety Disorder
Generalized Anxiety Disorder
About this trial
This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Generalized Anxiety Disorder (GAD)
Eligibility Criteria
Inclusion Criteria:
- Primary diagnosis of generalized anxiety disorder (GAD) either moderate or severe as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) as confirmed by the MINI at Screening, in addition to a psychiatric evaluation by a board- certified or Biohaven-approved board-eligible psychiatrist; The duration of illness must be ≥ 1 year
- Hamilton Anxiety Rating Scale (HAM-A) Total Score of ≥ 18 at both Screening and Baseline
- Clinical Global Impression of Severity Scale (CGI-S) score of ≥ 4 at both Screening and Baseline
- Determined by the investigator to be medically stable at baseline/randomization as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing. Participants must be physically able and expected to complete the trial as designed
- Minimum of 6 years of education or equivalent to complete necessary scales and understand consent forms
- Participants must be able to understand and agree to comply with the prescribed dosage regimens and procedures; report for regularly scheduled office visits; and reliably communicate with study personnel about adverse events and concomitant medications
- Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to dosing at Baseline
Exclusion Criteria:
- Participants with a primary DSM-V psychiatric disorder diagnosis other than GAD within the past 6-months. Note: Participants with a secondary diagnosis of comorbid social anxiety disorder or specific phobia are allowed, if in the investigator's judgement, the diagnosis is not sufficiently prominent and active so as to be confound the assessment of GAD symptoms
- Participants should be excluded at screening or baseline if any medical or psychiatric condition other than GAD, as specified in the inclusion criteria, could predominantly explain or contribute significantly to the subjects' symptoms or that could confound assessment of GAD symptoms
- Participants who report a history of inadequate response (per investigator judgement) to 3 or more adequate trials (including current trial) of any SSRI or SNRI, at an adequate dose and adequate duration (at least 8 weeks) for the treatment of GAD within the 3 years prior to randomization
- Hamilton Depression Rating Scale 17 (HAM-D-17) item 1 of >1 at Screening or Baseline
- HAM-D-17 of > 19 at Baseline
- Any eating disorder within the last 12 months prior to Screening
- Acute suicidality in the last 12 months, or suicide attempt or self-injurious behavior in the last 12 months prior to Screening
- Score of >0 on the Sheehan Suicidality Tracking Scale for the period of 12 months prior to screening, and at baseline
- History of psychosurgery, deep brain stimulation (DBS) or electroconvulsive therapy (ECT)
Sites / Locations
- Woodland International Research Group
- Axiom Research, LLC
- Pharmacology Research Institute
- University of California, San Francisco-Fresno
- Collaborative Neuroscience Network, LLC.
- Synergy San Diego
- Pharmacology Research Institute
- CalNeuro Research Group
- Pharmacology Research Institute
- Pacific Research Partners, LLC
- NRC Research Institute
- Desert Valley Research
- Atemis Institute for Clinical Research
- California Neuroscience Research Medical Group, Inc
- CNS Network
- Pacific Clinical Research Medical Group
- Child Study Center at Yale University School of Medicine
- Comprehensive Psychiatric Care
- Meridien Research
- Gulfcoast Clinical Research Center
- Galiz Research
- Clinical Neuroscience Solutions, Inc
- Harmony Clinical Research
- Clinical Neuroscience Solutions, Inc
- Stedman Clinical Trials
- iResearch Atlanta LLC
- Northwest Behavioral Research Center
- Phoenix Medical Research
- Heartland Research Associates, LLC
- Boston Clinical Trials
- BTC of New Bedford
- Altea Research Institute
- Center for Emotional Fitness
- Albuquerque Neuroscience Inc.
- SPRI Clinical Trials, LLC
- Richmond Behavioral Associates
- New Hope Clinical Research
- Midwest Clinical Research Center
- IPS Research Company
- Summit Research Network (Oregon) Inc.
- Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)
- Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)
- Suburban Research Associates, Inc.
- Keystone Clinical Studies, LLC
- University of Pennsylvania
- Volunteer Research Group, an AMR Company
- Clinical Neuroscience Solutions, Inc
- FutureSearch Trials of Dallas, LP
- InSite Clinical Research
- Baylor College of Medicine
- Red Oak Psychiatry Associates, PA
- Grayline Clinical Drug Trials
- Northwest Clinical Research Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Troriluzole
Placebo
Randomization phase (Weeks 1 through 8): Participants received troriluzole 100 mg capsules twice daily (BID) orally for up to 8 weeks in the double-blind (DB) randomization phase. Extension phase (Weeks 9 through 56): Participants, who completed the randomization phase and for whom the investigator believed open-label (OL) treatment could offer an acceptable risk-benefit profile, entered the extension phase and received OL troriluzole capsules (continuing on the same dose and regimen that was taken at the end of the randomization phase) for up to additional 48 weeks.
Randomization Phase (Weeks 1 through 8): Participants received troriluzole matching placebo capsules BID orally for up to 8 weeks in the DB randomization phase. Extension Phase (Weeks 9 through 56): Participants, who completed the randomization phase and for whom the investigator believed OL treatment could offer an acceptable risk-benefit profile, entered the extension phase and received OL troriluzole capsules (continuing on the same dose and regimen that was taken at the end of the randomization phase) for up to additional 48 weeks.