To determine the safety, efficacy and tolerability of SEP-225289 in subjects with Major
Depressive Disorder
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Inclusion Criteria:
- The duration of the current episode must be at least 1 month but not longer than 12
months.
- Subjects must have a primary diagnosis of Major Depressive Disorder.
- Subjects must have had at least one previous, diagnosed episode of MDD in the past 5
years.
- MDD must be the condition that was chiefly responsible for motivating the subject to
seek treatment.
- Subject is in general good health.
Exclusion Criteria:
- Subject is participating in, has participated in, or plans to participate in any
investigational drug study.
- Subject who has donated blood within the last 30 days or plans to donate blood during
and 30 days following participation.
- Known failure to respond (in the past 5 years) to two adequate (dose and duration)
antidepressant medications with distance mechanisms of action including tricyclics.
- Subjects who have undergone Electroconvulsive Therapy treatment.
- Treatment with fluoxetine, in the 6 weeks before baseline.
- Subject with psychotic disorders, anorexia nervosa, bulimia or post-traumatic stress
disorder.
- Subject with a history or presence of bipolar disorder (i. e., current or past history
of manic episode).
- Subjects with Obsessive Compulsive Disorder.
- Subjects with a lifetime diagnosis of Panic Disorder.
- Subject received treatment with antidepressants within 2 weeks.
- Subject with lifetime history of suicidal attempts, alcohol dependence or abuse,
drug(s) dependence or abuse (excluding nicotine and caffeine) or has a positive urine
drug screen.
- Subject has a history of significant risk of suicide or homicide.
- Bereavement - Defined as death of a loved one within 3 months.
- Subject has a documented history of HIV, hepatitis B or hepatitis C.
Little Rock, Arkansas 72211, United States
Arcadia, California 91007, United States
Beverly Hills, California 90210, United States
Costa Mesa, California 92626, United States
Garden Grove, California 92845, United States
Glendale, California 91204, United States
Irvine, California 92618, United States
Lafayette, California 94549, United States
Oceanside, California 92056, United States
San Diego, California 92103, United States
Upland, California 91786, United States
Denver, Colorado 80204, United States
Denver, Colorado 80239, United States
New Britain, Connecticut 06050, United States
Bradenton, Florida 34208, United States
Fort Myers, Florida 33912, United States
Jacksonville, Florida 32216, United States
Lauderhill, Florida 33139, United States
Maitland, Florida 32751, United States
North Miami, Florida 33161, United States
Sanford, Florida 32771, United States
Atlanta, Georgia 30328, United States
Atlanta, Georgia 30341, United States
Smyrna, Georgia 30080, United States
Park Ridge, Illinois 60068, United States
Lake Charles, Louisiana 70601, United States
Boston, Massachusetts 02135, United States
Braintree, Massachusetts 02184, United States
Flowood, Mississippi 39232, United States
St. Charles, Missouri 63301, United States
Clementon, New Jersey 08021, United States
Albuquerque, New Mexico 87109, United States
Bronx, New York 10454, United States
Bronx, New York 10467, United States
Brooklyn, New York 11235, United States
New York, New York 10021, United States
New York, New York 10023, United States
New York, New York 10075, United States
Raleigh, North Carolina 27609, United States
Cincinnati, Ohio 45227, United States
Dayton, Ohio 45408, United States
Middleburg Heights, Ohio 44130, United States
Oklahoma City, Oklahoma 73112, United States
Portland, Oregon 97210, United States
Philadelphia, Pennsylvania 19149, United States
Austin, Texas 78756, United States
Dallas, Texas 75231, United States
Houston, Texas 77040, United States
Irving, Texas 75062, United States
Midlothian, Virginia 23112, United States
Seattle, Washington 98104, United States