Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Major Depressive Disorder (CLARITY)



Status:Completed
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:11/8/2018
Start Date:December 2016
End Date:October 2018

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A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Major Depressive Disorder

To assess the efficacy of pimavanserin compared to placebo when given adjunctively to a
selective serotonin reuptake inhibitor (SSRI)/serotonin-norepinephrine reuptake inhibitor
(SNRI) antidepressant as treatment of patients with Major Depressive Disorder (MDD) and an
inadequate response to antidepressant therapy


Inclusion Criteria:

1. Adult patients, aged 18 years and above

2. A clinical diagnosis of major depressive disorder (MDD)

3. Is being treated with one of the following SSRI or SNRI antidepressants as
monotherapy:

- Citalopram

- Escitalopram

- Paroxetine

- Fluoxetine

- Sertraline

- Duloxetine

- Venlafaxine

- Desvenlafaxine

- Venlafaxine XR

4. Has a history of inadequate response to antidepressant treatments

Exclusion Criteria:

1. Patient has a psychotic disorder other than MDD

2. Patient has current evidence of a serious and/or unstable neurologic, cardiovascular,
respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder,
including cancer or malignancies, which would affect the patient's ability to
participate in the program

3. Patient has a history or symptoms of long QT syndrome

Patients will be evaluated at screening to ensure that all criteria for study participation
are met. Patients may be excluded from the study based on these assessments (and
specifically if it is determined that their baseline health and psychiatric condition do
not meet all pre-specified entry criteria).
We found this trial at
36
sites
Bradenton, Florida
1132
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Bradenton, FL
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1648 Pierce Dr NE
Atlanta, Georgia 30322
(404) 727-5640
Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
803
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Atlanta, GA
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
569
mi
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Houston, TX
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Berlin, New Jersey
1237
mi
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Berlin, NJ
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UAB
Birmingham, Alabama 35233
684
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Birmingham, AL
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900
mi
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Canton, OH
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Charleston, South Carolina 29405
1059
mi
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Charleston, SC
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Chicago, Illinois 60612
609
mi
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Chicago, IL
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Clinton, Utah 84015
792
mi
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Clinton, UT
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Dallas, Texas 75231
342
mi
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Dallas, TX
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Dallas, Texas 75231
345
mi
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Dallas, TX
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Decatur, Georgia 30030
805
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Decatur, GA
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Garden Grove, California 92845
1162
mi
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Garden Grove, CA
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Hoffman Estates, Illinois 60169
593
mi
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Hoffman Estates, IL
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Jacksonville, Florida 32256
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Jacksonville, FL
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Las Vegas, Nevada 89102
963
mi
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Las Vegas, NV
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640 George Washington Highway
Lincoln, Rhode Island 02865
1421
mi
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Lincoln, RI
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Maitland, Florida 32751
1138
mi
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Maitland, FL
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National City, California 91950
1140
mi
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National City, CA
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New York, New York 10022
1288
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New York, NY
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Oakland, California 94612
1331
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Oakland, CA
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Oklahoma City, Oklahoma 73103
157
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Oklahoma City, OK
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Oklahoma City, Oklahoma 73112
158
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Oklahoma City, OK
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Orlando, Florida 32801
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Philadelphia, Pennsylvania 19104
1223
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Philadelphia, PA
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Portland, Oregon 97210
1385
mi
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Portland, OR
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Richardson, Texas 75080
337
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Richardson, TX
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Rochester, New York 14618
1124
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Rochester, NY
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609 West Dyke Road
Rogers, Arkansas 72758
226
mi
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Rogers, AR
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Saint Louis, Missouri 63141
403
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Saint Louis, MO
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Sherman Oaks, California 91403
1178
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Sherman Oaks, CA
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Temecula, California 92591
1119
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Temecula, CA
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Torrance, California 90502
1176
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Torrance, CA
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Upland, California 91786
1135
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Upland, CA
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Waukesha, Wisconsin 53188
621
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Waukesha, WI
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Wichita, Kansas 67214
?
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Wichita, KS
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