Clinical trial NCT00584974: A Safety, Efficacy and Tolerability Study of SEP-225289
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depressive Disorder, Major
Keywords: Depression
Mental Disorders
Mood Disorders
Depressive Disorder, Major
Dysthymic Disorder
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2008-01-02
Enrollment: 523
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To assess the safety, efficacy and tolerability of SEP-225289 in subjects with Major Depressive Disorder (MDD)
timeFrame: 56 days
Secondary outcomes:
measure: To examine the response to SEP-225289 in MDD subjects meeting DSM_IV criteria for atypical and melancholic features
timeFrame: 56 days
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Arcadia
country: United States
state: California
city: Beverly Hills
country: United States
state: California
city: Costa Mesa
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: Glendale
country: United States
state: California
city: Irvine
country: United States
state: California
city: Lafayette
country: United States
state: California
city: Oceanside
country: United States
state: California
city: San Diego
country: United States
state: California
city: Upland
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: New Britain
country: United States
state: Connecticut
city: Bradenton
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Lauderhill
country: United States
state: Florida
city: Maitland
country: United States
state: Florida
city: North Miami
country: United States
state: Florida
city: Sanford
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Smyrna
country: United States
state: Georgia
city: Park Ridge
country: United States
state: Illinois
city: Lake Charles
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Braintree
country: United States
state: Massachusetts
city: Flowood
country: United States
state: Mississippi
city: St. Charles
country: United States
state: Missouri
city: Clementon
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Bronx
country: United States
state: New York
city: Bronx
country: United States
state: New York
city: Brooklyn
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Middleburg Heights
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Irving
country: United States
state: Texas
city: Midlothian
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Medical Director, CNS
role: STUDY_CHAIR
References: