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A Safety, Efficacy and Tolerability Study of SEP-225289

Information source: Sunovion
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depressive Disorder, Major

Intervention: SEP-225289 (Drug); SEP-225289 (Drug); Venlafaxine (Drug); placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Sunovion

Official(s) and/or principal investigator(s):
Medical Director, CNS, Study Chair, Affiliation: Sunovion


To determine the safety, efficacy and tolerability of SEP-225289 in subjects with Major Depressive Disorder

Clinical Details

Official title: 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)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: To assess the safety, efficacy and tolerability of SEP-225289 in subjects with Major Depressive Disorder (MDD)

Secondary outcome: To examine the response to SEP-225289 in MDD subjects meeting DSM_IV criteria for atypical and melancholic features

Detailed description: This is a randomized, placebo-controlled, double-dummy, multi-center study of the safety, efficacy and tolerability of SEP-225289 in male and female subjects with MDD. Subjects meeting DSM-IV criteria for Melancholic or Atypical Features specifier are eligible for participation. The study will consist of a screening period, which may last up to 2 weeks, an eight week (56 day) double-blind treatment period, a two week (14 day) wash-out, and a one week (7 day) follow up. Total subject participation will be approximately 91 days (13 weeks). This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.


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


- 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


- 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


- 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.

Locations and Contacts

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

Additional Information

Starting date: December 2007
Last updated: February 21, 2012

Page last updated: August 23, 2015

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