AV-101 as Adjunct Antidepressant Therapy in Patients With Major Depression



Status:Recruiting
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:2/28/2019
Start Date:March 5, 2018
End Date:June 30, 2019
Contact:Ashley Sullivan
Email:VSGCL003@cato.com
Phone:919-443-3403

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Double-Blind, Placebo-Controlled, Phase 2 Trial to Test Efficacy and Safety of AV-101 (L-4-chlorokynurenine) as Adjunct to Current Antidepressant Therapy in Patients With Major Depressive Disorder (the ELEVATE Study)

The study will evaluate the safety and efficacy of AV-101.


Inclusion Criteria:

- Diagnosed with MDD, single or recurrent, and currently experiencing a MDE of at least
8 weeks in duration.

- Has a history of inadequate response to at least 1 approved antidepressant including
at least 1 and no more than 3 during the current depressive episode.

- Meet the threshold on the total HAMD-17 score of > 20

- If female, a status of nonchildbearing potential or use of an acceptable form of birth
control.

- Body mass index between 18 to 40 kg/m2.

- Other criteria may apply

Exclusion Criteria:

- History of bipolar disorder, schizophrenia or schizoaffective disorders, or any
history of psychotic symptoms in the current or previous depressive episodes.

- Any Axis I or Axis II Disorder, which at screening is clinically predominant to their
MDD or has been predominant to their MDD at any time within 6 months prior to
screening.

- Women who are pregnant or breastfeeding or a positive pregnancy test at screening or
baseline.

- Currently taking a prohibited adjunct therapy. Such drugs must be washed out for at
least 4 weeks prior to baseline.

- Current diagnosis of moderate or severe substance use (including alcohol) disorder
(abuse or dependence, as defined by DSM-5), with the exception of nicotine dependence,
at screening or within 6 months prior to screening.

- In the opinion of the investigator, the subject has a significant risk for suicidal
behavior

- Has received electroconvulsive therapy, or had repetitive transcranial magnetic
stimulation in the current episode.

- Has received vagus nerve stimulation at any time prior to screening.

- Any current or past history of any physical condition, which in the investigator's
opinion might put the subject at risk or interfere with study results interpretation.
We found this trial at
21
sites
Dayton, Ohio 45417
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Atlanta, Georgia 30331
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Atlanta, GA
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Augusta, Georgia 30912
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Bellevue, Washington 98007
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Fort Myers, Florida 33912
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Gaithersburg, Maryland 20877
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Gaithersburg, MD
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Garden Grove, California 92845
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Hoffman Estates, Illinois 60169
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Houston, Texas 77030
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Houston, TX
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Jacksonville, Florida 32256
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Jacksonville, FL
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Lake Charles, Louisiana 70629
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Los Angeles, California 90024
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Media, Pennsylvania 19063
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Media, PA
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National City, California 91950
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National City, CA
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New York, New York 10128
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New York, NY
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Oakland, California 94607
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Oakland, CA
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Oklahoma City, Oklahoma 73112
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Oklahoma City, OK
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Rochester, New York 14618
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Rochester, NY
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Saint Louis, Missouri 63141
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Saint Louis, MO
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San Diego, California 92103
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San Diego, CA
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Temecula, California 92591
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Temecula, CA
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