Study of Adjunctive or Monotherapy Rapastinel Treatment in Patients With Major Depressive Disorder (MDD)



Status:Enrolling by invitation
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 75
Updated:12/19/2018
Start Date:August 23, 2018
End Date:March 15, 2021

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An Open-label, Long-term Extended Access Protocol for Rapastinel as Adjunctive or Monotherapy Treatment in Patients With Major Depressive Disorder

Multicenter, open-label, long-term extended access treatment protocol in adult patients with
a primary diagnosis of MDD.


Inclusion Criteria:

- Completion of lead-in study

- Adequate therapeutic benefit in the lead-in study to justify continuation of treatment
with rapastinel in the judgement of the investigator

Exclusion Criteria:

- Suicide risk, as determined by meeting any of the following criteria:

1. A suicide attempt within the past year

2. Significant risk, as judged by the investigator, based on the psychiatric
interview or information collected in the Columbia- Suicide Severity Rating Scale
(C-SSRS) at any visit in the lead-in study

3. Montgomery-Asberg Depression Rating Scale (MADRS) Item 10 score ≥ 5 at any visit
during participation in the lead-in study where MADRS was conducted.

- At imminent risk of injuring self or others or causing significant damage to property,
as judged by the investigator

- Females who are pregnant, breastfeeding, or planning to become pregnant or breastfeed
during participation

- Females of childbearing potential and male partners of females of childbearing
potential, not using a reliable means of contraception
We found this trial at
74
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Hialeah, Florida 33012
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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2417 Marshall Ave.
Imperial, California 92251
760-355-0176
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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Albuquerque, New Mexico 87109
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Allentown, Pennsylvania 18104
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3015 Flowers Road South
Atlanta, Georgia 30341
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Austin, Texas 78737
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Austin, Texas 78754
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2026 Wirt Road
Bellaire, Texas 77401
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Bradenton, Florida
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Brooklyn, New York 11235
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Charleston, South Carolina 29405
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Charlottesville, Virginia 22903
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Cincinnati, Ohio 45242
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Costa Mesa, California 92626
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Culver City, California 90230
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Dayton, OH
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Decatur, Georgia 30030
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Dothan, Alabama 36303
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Encino, California 91316
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Flowood, Mississippi 39232
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Fort Myers, Florida 33912
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200 West Magnolia Avenue
Fort Worth, Texas 76104
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Glendale, California 91204
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Hoffman Estates, Illinois 60169
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Houston, Texas 17115
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1002 Gemini Avenue
Houston, Texas 77058
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Irvine, California 92618
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Lake Charles, Louisiana 70601
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Lakeland, Florida 33805
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Lauderhill, Florida 33319
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Lemon Grove, California 91945
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Libertyville, Illinois 60048
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Little Rock, Arkansas 72211
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Los Alamitos, California 90720
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Marietta, Georgia 30060
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Memphis, Tennessee 38119
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Methuen, Massachusetts 01844
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Mount Pleasant, South Carolina 29464
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Naperville, Illinois 60563
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30 Temple Street
Nashua, New Hampshire 03060
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New York, New York 10022
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2460 General Armistead Avenue
Norristown, Pennsylvania 20006
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Norwich, Connecticut 06360
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O'Fallon, Missouri 63368
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Oakland Park, Florida 33334
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Oklahoma City, Oklahoma 73112
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Oklahoma City, Oklahoma 73112
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Oklahoma City, Oklahoma 73112
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Orange City, Florida 32763
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Orlando, Florida 32819
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Phoenix, Arizona 85032
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Portland, Oregon 97210
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Riverside, California 92506
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Rochester, New York 14618
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609 West Dyke Road
Rogers, Arkansas 72758
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4801 Weldon Spring Parkway
Saint Charles, Missouri 63301
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Salt Lake City, Utah 84105
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Sherman Oaks, California 91403
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Shreveport, Louisiana 71115
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Smyrna, Georgia 30080
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851 Main Street
South Weymouth, Massachusetts 02190
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Staten Island, New York 10312
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Temecula, California 92591
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Toms River, New Jersey 08755
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Upland, California 91786
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Wichita Falls, Texas 76309
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55 N Lake Ave
Worcester, Massachusetts 01655
(508) 856-8989
Univ of Massachusetts Med School As the commonwealth's only public medical school, we take seriously...
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