Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder



Status:Completed
Conditions:Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:1/6/2019
Start Date:October 27, 2011
End Date:December 23, 2013

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

The SPD489-322 Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible Dose Titration, Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder With Inadequate Response to Prospective Treatment With an Antidepressant

This study will examine SPD489 in subjects aged 18-65 with major depressive disorder (MDD)
who are taking certain types of antidepressants but continue to have residual depression
symptoms. Eligible patients will remain on their antidepressant but will be randomized to
either receive supplemental SPD489 or placebo (i.e. sugar pill). The purpose of this study is
to help answer the following questions:

- How safe is SPD489 for the supplemental treatment of depression and what are the side
effects that might be related to it?

- Can supplemental SPD489 help patients who still have residual depression symptoms while
taking an antidepressant?

- How much SPD489 should be given to patients with depression who are also taking an
antidepressant?

- How does SPD489 compare to placebo in depressed patients who are also taking an
antidepressant?


Inclusion Criteria:

- Subject is able to provide written, personally signed, and dated informed consent to
participate in the study.

- Subject is between 18 and 65 years of age.

- Subject has a primary diagnosis of non-psychotic MDD (single or recurrent).

- Subject has a MADRS total score 24.

- Subject who is female, must have a negative serum beta human chorionic gonadotropin
(HCG) pregnancy test and a negative urine pregnancy test at the and agrees to comply
with any applicable contraceptive requirements of the protocol.

- Subject is able to swallow a capsule.

Exclusion Criteria:

- Subject whose current episode of MDD has not responded to an adequate treatment
regimen with 2 or more approved single antidepressant agents.

- Subject who has a lifetime history of treatment resistant depression.

- Subject has a current co-morbid psychiatric disorder. Excluded are: any significant
Axis II disorder (including borderline personality disorder), any bipolar disorder,
any current or lifetime psychosis, post traumatic stress disorder, obsessive
compulsive disorder, any pervasive development disorder, anorexia nervosa and bulimia
nervosa.

- Subject has been hospitalized (within the last 12 months) for their current MDD
episode.

- Subject has a current or lifetime history of attention-deficit/hyperactivity disorder
(ADHD).

- Subject has a first degree relative that has been diagnosed with bipolar I disorder.

- Subject has a recent history (within the last 6 months) of suspected substance abuse
or dependence disorder

- Subject is considered a suicide risk in the opinion of the Investigator, has
previously made a suicide attempt within the past 3 years, or is currently
demonstrating active suicidal ideation.

- Subject has a concurrent chronic or acute illness or unstable medical condition.

- Subject has a history of seizures (other than infantile febrile seizures), any tic
disorder, or a current diagnosis and/or a known family history of Tourette's Disorder,
serious neurological disease, history of significant head trauma, dementia,
cerebrovascular disease, Parkinson's disease, or intracranial lesions.

- Subject has known history of symptomatic cardiovascular disease, advanced
arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm
abnormalities, coronary artery disease, or other serious cardiac problems.

- Subject has a history of thyroid disorder that has not been stabilized on thyroid
medication or treatment within 3 months prior to the Screening Visit.

- Subject has a known family history of sudden cardiac death or ventricular arrhythmia.

- Subject has glaucoma.

- Subject has a history of moderate to severe hypertension.

- Current use of any other medications (including over-the-counter [OTC], herbal or
homeopathic preparations) that have central nervous system effects.

- Subject has had electroconvulsive therapy (ECT) for the current depressive episode 3
months prior.

- The subject has a known or suspected intolerance, hypersensitivity, or
contraindications to their assigned antidepressant treatments (escitalopram oxalate,
sertraline HCl, venlafaxine HCl extended release, or duloxetine HCl).

- Subject has a positive urine drug result.

- Subject has a body mass index (BMI) of <18.5 or >40.

- Subject is female and is pregnant or nursing.
We found this trial at
48
sites
Penticton, British Columbia V2A 4M4
?
mi
from
Penticton,
Click here to add this to my saved trials
4460 Red Bank Expressway
Cincinnati, Ohio 45227
513-721-3868
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
?
mi
from
Orlando, FL
Click here to add this to my saved trials
901 Boren Avenue
Seattle, Washington 98104
206-624-4587
?
mi
from
Seattle, WA
Click here to add this to my saved trials
3212 Cove Bend Drive
Tampa, Florida 33613
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Austin, Texas 78756
?
mi
from
Austin, TX
Click here to add this to my saved trials
Baltimore, Maryland 21208
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Birmingham, Alabama 35216
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Bridgeville, Pennsylvania 15107
?
mi
from
Bridgeville, PA
Click here to add this to my saved trials
Carson, California 90746
?
mi
from
Carson, CA
Click here to add this to my saved trials
Clinton, Utah 84015
?
mi
from
Clinton, UT
Click here to add this to my saved trials
Coral Springs, Florida 33067
?
mi
from
Coral Springs, FL
Click here to add this to my saved trials
Durham, North Carolina 27707
?
mi
from
Durham, NC
Click here to add this to my saved trials
East Providence, Rhode Island 02914
?
mi
from
East Providence, RI
Click here to add this to my saved trials
Florence, Kentucky 41042
?
mi
from
Florence, KY
Click here to add this to my saved trials
Fort Walton Beach, Florida 32547
?
mi
from
Fort Walton Beach, FL
Click here to add this to my saved trials
Gaithersburg, Maryland 20877
?
mi
from
Gaithersburg, MD
Click here to add this to my saved trials
Hamden, Connecticut 06518
?
mi
from
Hamden, CT
Click here to add this to my saved trials
Indianapolis, Indiana 46260
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Irvine, CA
Click here to add this to my saved trials
Maitland, Florida 32751
?
mi
from
Maitland, FL
Click here to add this to my saved trials
?
mi
from
Mason, OH
Click here to add this to my saved trials
Media, Pennsylvania 19063
?
mi
from
Media, PA
Click here to add this to my saved trials
Memphis, Tennessee 38119
?
mi
from
Memphis, TN
Click here to add this to my saved trials
Middletown, Connecticut 06457
?
mi
from
Middletown, CT
Click here to add this to my saved trials
Mount Kisco, New York 10549
?
mi
from
Mount Kisco, NY
Click here to add this to my saved trials
Nashville, Tennessee 37203
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New Port Richey, Florida 34652
?
mi
from
New Port Richey, FL
Click here to add this to my saved trials
New York, New York 10168
?
mi
from
New York, NY
Click here to add this to my saved trials
Norwalk, California 90650
?
mi
from
Norwalk, CA
Click here to add this to my saved trials
Oak Brook, Illinois 60523
?
mi
from
Oak Brook, IL
Click here to add this to my saved trials
Oceanside, California 92056
?
mi
from
Oceanside, CA
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73112
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Pasadena, California 91107
?
mi
from
Pasadena, CA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19139
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15261
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Portland, Oregon 97210
?
mi
from
Portland, OR
Click here to add this to my saved trials
Raleigh, North Carolina 27809
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Rockville, Maryland 20852
?
mi
from
Rockville, MD
Click here to add this to my saved trials
?
mi
from
Saint Charles, MO
Click here to add this to my saved trials
Saint Petersburg, Florida 33709
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
San Diego, California 92123
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Diego, California 92108
?
mi
from
San Diego, CA
Click here to add this to my saved trials
10655 Roselle Street
San Diego, California 92128
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Smyrna, Georgia 30080
?
mi
from
Smyrna, GA
Click here to add this to my saved trials
Staten Island, New York 10312
?
mi
from
Staten Island, NY
Click here to add this to my saved trials
?
mi
from
Valparaiso, IN
Click here to add this to my saved trials
Watertown, Massachusetts
?
mi
from
Watertown, MA
Click here to add this to my saved trials