Randomized Trial of Adult Subjects With Generalized Anxiety Disorder



Status:Recruiting
Conditions:Anxiety, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:4/6/2019
Start Date:February 19, 2019
End Date:October 20, 2019
Contact:Robert Berman
Email:clinicaltrials@biohavenpharma.com
Phone:203-404-0410

Use our guide to learn which trials are right for you!

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

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


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

- 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

Exclusion Criteria:

- 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)
We found this trial at
50
sites
Encino, California 91316
Phone: 818-705-7451
?
mi
from
Encino, CA
Click here to add this to my saved trials
One Utah Avenue
Cherry Hill, New Jersey 08002
856-857-9500
?
mi
from
Cherry Hill, NJ
Click here to add this to my saved trials
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Phone: 713-798-4095
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
?
mi
from
Houston, TX
Click here to add this to my saved trials
3212 Cove Bend Drive
Tampa, Florida 33613
Phone: 813-971-8311
?
mi
from
Tampa, FL
Click here to add this to my saved trials
1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
Phone: 316-689-6626
?
mi
from
Wichita, KS
Click here to add this to my saved trials
Albuquerque, New Mexico 87109
Phone: 505-858-3773
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Bellevue, Washington 98007
Phone: 425-453-0404
?
mi
from
Bellevue, WA
Click here to add this to my saved trials
Boston, Massachusetts 02135
Phone: 617-477-4868
?
mi
from
Boston, MA
Click here to add this to my saved trials
Bradenton, Florida
Phone: 941-756-8680
?
mi
from
Bradenton, FL
Click here to add this to my saved trials
Brooklyn, New York 11235
Phone: 718-616-2070
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Colton, California 92324
Phone: 909-824-2325
?
mi
from
Colton, CA
Click here to add this to my saved trials
Dallas, Texas 75231
Phone: 214-369-2600
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dayton, Ohio 45408
Phone: 937-424-1050
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Decatur, Georgia 30030
Phone: 404-537-1281
?
mi
from
Decatur, GA
Click here to add this to my saved trials
Fort Myers, Florida 33912
Phone: 239-561-0009
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
Fresno, California
Phone: 559-499-6636
?
mi
from
Fresno, CA
Click here to add this to my saved trials
Garden Grove, California 92845
Phone: 714-799-7799
?
mi
from
Garden Grove, CA
Click here to add this to my saved trials
Hialeah, Florida 33016
Phone: 305-805-0921
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
Houston, Texas 17115
Phone: 281-893-4111
?
mi
from
Houston, TX
Click here to add this to my saved trials
Jacksonville, Florida 32216
Phone: 904-281-5757
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Las Vegas, Nevada 89102
Phone: 702-527-7401
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Lemon Grove, California 91945
Phone: 619-303-6130
?
mi
from
Lemon Grove, CA
Click here to add this to my saved trials
640 George Washington Highway
Lincoln, Rhode Island 02865
Phone: 401-305-5200
?
mi
from
Lincoln, RI
Click here to add this to my saved trials
Little Rock, Arkansas 72211
Phone: 501-221-8681
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Los Alamitos, California 90720
Phone: 714-827-3667
?
mi
from
Los Alamitos, CA
Click here to add this to my saved trials
10850 Wilshire Boulevard
Los Angeles, California 90024
Phone: 310-208-7144
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Marietta, Georgia 30060
Phone: 770-422-2846
?
mi
from
Marietta, GA
Click here to add this to my saved trials
Media, Pennsylvania 19063
Phone: 610-891-9024
?
mi
from
Media, PA
Click here to add this to my saved trials
Memphis, Tennessee 38119
Phone: 901-843-1045
?
mi
from
Memphis, TN
Click here to add this to my saved trials
New Haven, Connecticut 06519
Phone: 203-785-6906
?
mi
from
New Haven, CT
Click here to add this to my saved trials
Newport Beach, California 92660
Phone: 949-752-7910
?
mi
from
Newport Beach, CA
Click here to add this to my saved trials
Norristown, Pennsylvania 19403
Phone: 610-277-8073
?
mi
from
Norristown, PA
Click here to add this to my saved trials
North Miami Beach, Florida 33162
Phone: 305-957-7200
?
mi
from
North Miami Beach, FL
Click here to add this to my saved trials
Norwich, Connecticut 06360
Phone: 860-886-1508
?
mi
from
Norwich, CT
Click here to add this to my saved trials
Oakland, California 94612
Phone: 510-444-2877
?
mi
from
Oakland, CA
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73103
Phone: 405-235-8188
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Orange, California 92868
Phone: 714-289-1100
?
mi
from
Orange, CA
Click here to add this to my saved trials
Orlando, Florida 32806
Phone: 407-425-5100
?
mi
from
Orlando, FL
Click here to add this to my saved trials
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Phone: 214-746-6662
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Portland, Oregon 97210
Phone: 503-972-9803
?
mi
from
Portland, OR
Click here to add this to my saved trials
Portland, Oregon 97210
Phone: 503-276-6224
?
mi
from
Portland, OR
Click here to add this to my saved trials
Prairie Village, Kansas 66206
Phone: 913-381-7180
?
mi
from
Prairie Village, KS
Click here to add this to my saved trials
Rancho Mirage, California 92270
Phone: 760-464-0470
?
mi
from
Rancho Mirage, CA
Click here to add this to my saved trials
Salem, Oregon 97301
Phone: 503-540-0100
?
mi
from
Salem, OR
Click here to add this to my saved trials
San Marcos, California 92078
Phone: 760-266-4144
?
mi
from
San Marcos, CA
Click here to add this to my saved trials
Sherman Oaks, California 91403
Phone: 818-990-2671
?
mi
from
Sherman Oaks, CA
Click here to add this to my saved trials
Staten Island, New York 10312
Phone: 718-317-5522
?
mi
from
Staten Island, NY
Click here to add this to my saved trials
Torrance, California 90502
Phone: 310-523-4200
?
mi
from
Torrance, CA
Click here to add this to my saved trials
Upland, California 91786
Phone: 909-920-3000
?
mi
from
Upland, CA
Click here to add this to my saved trials
Wichita Falls, Texas 76309
Phone: 940-322-1131
?
mi
from
Wichita Falls, TX
Click here to add this to my saved trials