A Safety, Efficacy and Tolerability Study of SEP-225289
A Double-Blind, Placebo-Controlled Study Examining The Safety, Efficacy, and Tolerability of SEP-225289 in Subjects With Major Depressive Disorder (Including Atypical and Melancholic Features)
1 other identifier
interventional
523
1 country
51
Brief Summary
To determine the safety, efficacy and tolerability of SEP-225289 in subjects with Major Depressive Disorder
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2007
Shorter than P25 for phase_2
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 21, 2007
CompletedFirst Posted
Study publicly available on registry
January 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedFebruary 23, 2012
February 1, 2012
1.4 years
December 21, 2007
February 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the safety, efficacy and tolerability of SEP-225289 in subjects with Major Depressive Disorder (MDD)
56 days
Secondary Outcomes (1)
To examine the response to SEP-225289 in MDD subjects meeting DSM_IV criteria for atypical and melancholic features
56 days
Study Arms (4)
0.5 mg SEP-225289
EXPERIMENTAL0.5 mg SEP-225289
2.0 mg of SEP-225289
EXPERIMENTAL2.0 mg of SEP-225289
Venlafaxine
ACTIVE COMPARATOR150 mg Venlafaxine
Placebo
PLACEBO COMPARATORplacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
Unknown Facility
Little Rock, Arkansas, 72211, United States
Unknown Facility
Arcadia, California, 91007, United States
Unknown Facility
Beverly Hills, California, 90210, United States
Unknown Facility
Costa Mesa, California, 92626, United States
Unknown Facility
Garden Grove, California, 92845, United States
Unknown Facility
Glendale, California, 91204, United States
Unknown Facility
Irvine, California, 92618, United States
Unknown Facility
Lafayette, California, 94549, United States
Unknown Facility
Oceanside, California, 92056, United States
Unknown Facility
San Diego, California, 92103, United States
Unknown Facility
Upland, California, 91786, United States
Unknown Facility
Denver, Colorado, 80204, United States
Unknown Facility
Denver, Colorado, 80239, United States
Unknown Facility
New Britain, Connecticut, 06050, United States
Unknown Facility
Bradenton, Florida, 34208, United States
Unknown Facility
Fort Myers, Florida, 33912, United States
Unknown Facility
Jacksonville, Florida, 32216, United States
Unknown Facility
Lauderhill, Florida, 33139, United States
Unknown Facility
Maitland, Florida, 32751, United States
Unknown Facility
North Miami, Florida, 33161, United States
Unknown Facility
Sanford, Florida, 32771, United States
Unknown Facility
Atlanta, Georgia, 30328, United States
Unknown Facility
Atlanta, Georgia, 30341, United States
Unknown Facility
Smyrna, Georgia, 30080, United States
Unknown Facility
Park Ridge, Illinois, 60068, United States
Unknown Facility
Lake Charles, Louisiana, 70601, United States
Unknown Facility
Boston, Massachusetts, 02135, United States
Unknown Facility
Braintree, Massachusetts, 02184, United States
Unknown Facility
Flowood, Mississippi, 39232, United States
Unknown Facility
Saint Charles, Missouri, 63301, United States
Unknown Facility
Clementon, New Jersey, 08021, United States
Unknown Facility
Albuquerque, New Mexico, 87109, United States
Unknown Facility
Brooklyn, New York, 11235, United States
Unknown Facility
New York, New York, 10021, United States
Unknown Facility
New York, New York, 10023, United States
Unknown Facility
New York, New York, 10075, United States
Unknown Facility
The Bronx, New York, 10454, United States
Unknown Facility
The Bronx, New York, 10467, United States
Unknown Facility
Raleigh, North Carolina, 27609, United States
Unknown Facility
Cincinnati, Ohio, 45227, United States
Unknown Facility
Dayton, Ohio, 45408, United States
Unknown Facility
Middleburg Heights, Ohio, 44130, United States
Unknown Facility
Oklahoma City, Oklahoma, 73112, United States
Unknown Facility
Portland, Oregon, 97210, United States
Unknown Facility
Philadelphia, Pennsylvania, 19149, United States
Unknown Facility
Austin, Texas, 78756, United States
Unknown Facility
Dallas, Texas, 75231, United States
Unknown Facility
Houston, Texas, 77040, United States
Unknown Facility
Irving, Texas, 75062, United States
Unknown Facility
Midlothian, Virginia, 23112, United States
Unknown Facility
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Medical Director, CNS
Sumitomo Pharma America, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2007
First Posted
January 2, 2008
Study Start
December 1, 2007
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
February 23, 2012
Record last verified: 2012-02