Treatment-Resistant Depression Registry



Status:Completed
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:January 2006
End Date:May 2015

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

A Long-term, Prospective, Observational, Multi-center Patient Outcome Registry to Collect Data in Patients With Treatment-resistant Depression (TRD) Who Are Currently in a Major Depressive Episode.

This registry will collect information about patients with treatment-resistant depression
(TRD) who are currently in a major depressive episode. For the purposes of this study, TRD
is defined as an ongoing depression lasting at least 2 years or that has recurred at least 3
times, to include the current episode, during the patient's lifetime AND has not adequately
responded to 4 or more adequate antidepressive treatments. The registry will follow the
clinical course and outcomes for patients with TRD who are treated with and without
adjunctive (used along with other treatments for depression) vagus nerve stimulation (VNS)
therapy.

Enrollment of TRD patients treated with VNS Therapy will consist of patients originally
enrolled in the registry as well as patients who have completed the D-21 Dosing Study and
are enrolled in the Registry for Long-Term Follow-up. Sites will maintain a screening log of
all patients who have been screened for original TRD Registry patients.

Please note that because this is a post-approval registry, Cyberonics does not cover the
cost of VNS Therapy implantation.

Inclusion Criteria:

- Patient diagnosed with a current major depressive episode according to DSM-IV-TR
criteria.

- For D-21 patients only who have completed the D-21 dosing Study without any D-21
inclusion and exclusion protocol deviation.

- Patient has been in the current depressive episode for 2 years or longer, or has had
at least 3 lifetime episodes including the current MDE.

- Patient has had an inadequate response to 4 or more adequate antidepressive
treatments.

- The patient has a CGI severity of illness score of moderately ill (score of 4) or
greater.

- The patient must be able to provide informed consent and complete all forms.

Exclusion Criteria:

- Patient has a history of schizophrenia, schizoaffective disorder, any other psychotic
disorder, or a current major depressive episode that includes psychotic features; or
is currently psychotic.

- Patient is currently enrolled in a double blind investigational study; patients who
have completed the double-blind D-21 study will be allowed to enter the Registry for
Long Term Follow-up

- Other than those patients who were enrolled in the D-21 study, patient has previously
received VNS therapy.

- Patient has a history of rapid cycling bipolar disorder.
We found this trial at
55
sites
Plano, Texas 75024
328
mi
from
Plano, TX
Click here to add this to my saved trials
Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
1049
mi
from
Gainesville, FL
Click here to add this to my saved trials
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
from
Houston, TX
Click here to add this to my saved trials
116th St and Broadway
New York, New York 10027
(212) 854-1754
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
1290
mi
from
New York, NY
Click here to add this to my saved trials
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
1383
mi
from
Portland, OR
Click here to add this to my saved trials
4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
571
mi
from
San Antonio, TX
Click here to add this to my saved trials
Amherst, New York 14226
1061
mi
from
Amherst, NY
Click here to add this to my saved trials
Amherst, New York 14228
1063
mi
from
Amherst, NY
Click here to add this to my saved trials
Baltimore, Maryland 21208
1142
mi
from
Baltimore, MD
Click here to add this to my saved trials
Baltimore, Maryland 21285
1149
mi
from
Baltimore, MD
Click here to add this to my saved trials
Beverly Hills, California
1176
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
Boca Raton, Florida 33431
1297
mi
from
Boca Raton, FL
Click here to add this to my saved trials
Brunswick, Georgia 31520
1034
mi
from
Brunswick, GA
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
1063
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlestown, Massachusetts 02129
1444
mi
from
Charlestown, MA
Click here to add this to my saved trials
898
mi
from
Cleveland, OH
Click here to add this to my saved trials
Columbus, Georgia
811
mi
from
Columbus, GA
Click here to add this to my saved trials
349
mi
from
Dallas, TX
Click here to add this to my saved trials
Decatur, Georgia 30030
805
mi
from
Decatur, GA
Click here to add this to my saved trials
Evanston, Illinois 60201
612
mi
from
Evanston, IL
Click here to add this to my saved trials
Evergreen Park, Illinois 60805
603
mi
from
Evergreen Park, IL
Click here to add this to my saved trials
263 Farmington Ave
Farmington, Connecticut 06030
(860) 679-2000
University of Connecticut Health Center UConn Health is a vibrant, integrated academic medical center that...
1350
mi
from
Farmington, CT
Click here to add this to my saved trials
Findlay, Ohio 45840
789
mi
from
Findlay, OH
Click here to add this to my saved trials
Flowood, Mississippi 39232
563
mi
from
Flowood, MS
Click here to add this to my saved trials
Garden Grove, California 92840
1158
mi
from
Garden Grove, CA
Click here to add this to my saved trials
Glen Burnie, Maryland 21061
1148
mi
from
Glen Burnie, MD
Click here to add this to my saved trials
Hoffman Estates, Illinois 60169
593
mi
from
Hoffman Estates, IL
Click here to add this to my saved trials
566
mi
from
Houston, TX
Click here to add this to my saved trials
1701 North Senate Avenue
Indianapolis, Indiana 46202
643
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Jamaica, New York 11418
1295
mi
from
Jamaica, NY
Click here to add this to my saved trials
Loma Linda University
Loma Linda, California 92354
(909) 558-4000
Loma Linda University Loma Linda University (LLU) is a Seventh-day Adventist educational health-sciences institution with...
1114
mi
from
Loma Linda, CA
Click here to add this to my saved trials
Macon, Georgia 31201
867
mi
from
Macon, GA
Click here to add this to my saved trials
Marietta, Georgia 30060
788
mi
from
Marietta, GA
Click here to add this to my saved trials
Mercer Island, Washington 98040
1404
mi
from
Mercer Island, WA
Click here to add this to my saved trials
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
636
mi
from
Milwaukee, WI
Click here to add this to my saved trials
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
1223
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15213
974
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
1113
mi
from
Richmond, VA
Click here to add this to my saved trials
Rochester Hills, Michigan 48307
844
mi
from
Rochester Hills, MI
Click here to add this to my saved trials
Sacramento, California 95816
1282
mi
from
Sacramento, CA
Click here to add this to my saved trials
Sacramento, California
1283
mi
from
Sacramento, CA
Click here to add this to my saved trials
Salt Lake City, Utah 84105
779
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Antonio, Texas 78229
571
mi
from
San Antonio, TX
Click here to add this to my saved trials
Shreveport, Louisiana 71115
441
mi
from
Shreveport, LA
Click here to add this to my saved trials
Skokie, Illinois 60076
609
mi
from
Skokie, IL
Click here to add this to my saved trials
St. Louis, Missouri 63110
413
mi
from
St. Louis, MO
Click here to add this to my saved trials
St. Louis, Missouri 63128
408
mi
from
St. Louis, MO
Click here to add this to my saved trials
St. Paul, Minnesota 55114
553
mi
from
St. Paul, MN
Click here to add this to my saved trials
Syracuse, New York 13210
1194
mi
from
Syracuse, NY
Click here to add this to my saved trials
Tucson, Arizona 85721
(520) 621-2211
University of Arizona The University of Arizona is a premier, public research university. Established in...
834
mi
from
Tucson, AZ
Click here to add this to my saved trials
Valdosta, Georgia 31602
956
mi
from
Valdosta, GA
Click here to add this to my saved trials
Wheaton, Illinois 60187
587
mi
from
Wheaton, IL
Click here to add this to my saved trials
Wichita, Kansas 67207
32
mi
from
Wichita, KS
Click here to add this to my saved trials
Winston Salem, North Carolina 27157
974
mi
from
Winston Salem, NC
Click here to add this to my saved trials
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...
1405
mi
from
Worcester, MA
Click here to add this to my saved trials