A Safety, Efficacy and Tolerability Study of SEP-225289
NCT ID: NCT00584974
Last Updated: 2012-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
523 participants
INTERVENTIONAL
2007-12-31
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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0.5 mg SEP-225289
0.5 mg SEP-225289
SEP-225289
0.5 mg SEP-225289
2.0 mg of SEP-225289
2.0 mg of SEP-225289
SEP-225289
2.0 mg SEP-225289
Venlafaxine
150 mg Venlafaxine
Venlafaxine
150 mg Venlafaxine
Placebo
placebo
placebo
Placebo
Interventions
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SEP-225289
0.5 mg SEP-225289
SEP-225289
2.0 mg SEP-225289
Venlafaxine
150 mg Venlafaxine
placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
55 Years
ALL
No
Sponsors
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Sumitomo Pharma America, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director, CNS
Role: STUDY_CHAIR
Sumitomo Pharma America, Inc.
Locations
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Little Rock, Arkansas, United States
Arcadia, California, United States
Beverly Hills, California, United States
Costa Mesa, California, United States
Garden Grove, California, United States
Glendale, California, United States
Irvine, California, United States
Lafayette, California, United States
Oceanside, California, United States
San Diego, California, United States
Upland, California, United States
Denver, Colorado, United States
Denver, Colorado, United States
New Britain, Connecticut, United States
Bradenton, Florida, United States
Fort Myers, Florida, United States
Jacksonville, Florida, United States
Lauderhill, Florida, United States
Maitland, Florida, United States
North Miami, Florida, United States
Sanford, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Smyrna, Georgia, United States
Park Ridge, Illinois, United States
Lake Charles, Louisiana, United States
Boston, Massachusetts, United States
Braintree, Massachusetts, United States
Flowood, Mississippi, United States
Saint Charles, Missouri, United States
Clementon, New Jersey, United States
Albuquerque, New Mexico, United States
Brooklyn, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
The Bronx, New York, United States
The Bronx, New York, United States
Raleigh, North Carolina, United States
Cincinnati, Ohio, United States
Dayton, Ohio, United States
Middleburg Heights, Ohio, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Austin, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Irving, Texas, United States
Midlothian, Virginia, United States
Seattle, Washington, United States
Countries
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Other Identifiers
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360-029
Identifier Type: -
Identifier Source: org_study_id
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