Randomized Trial of Adult Subjects With Generalized Anxiety Disorder

Eligibility: for people ages 18-65 (full criteria)
Location: at Fresno, California and other locations
Dates: study started February 19, 2019
estimated completion October 20, 2019

Description

The purpose of this study is to compare the efficacy of BHV-4157 versus placebo in subjects with Generalized Anxiety Disorder.

A Multicenter, Randomized, Double-Blind, Placebo Controlled Trial of Troriluzole in Generalized Anxiety Disorder

Generalized Anxiety Disorder Generalized Anxiety Disorder (GAD) Disease Anxiety Disorders Troriluzole

Open to people ages 18-65

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
HAM-A Total Score of ≥ 18 at both Screening and Baseline
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. Subjects 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
Subjects 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

Subjects with a primary DSM-V psychiatric disorder diagnosis other than GAD within the past 6-months. Note: Subjects 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
Subjects 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
Patients who report a history of inadequate response (per investigator judgement) to three (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
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)

University of California, San Francisco-Fresno accepting new patients
Fresno California 93701 United States
Pacific Research Partners, LLC accepting new patients
Oakland California 94607 United States