A Safety, Efficacy and Tolerability Study of SEP-225289

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00584974
Recruitment Status : Completed
First Posted : January 2, 2008
Last Update Posted : February 23, 2012
Information provided by (Responsible Party):

December 21, 2007
January 2, 2008
February 23, 2012
December 2007
May 2009   (Final data collection date for primary outcome measure)
To assess the safety, efficacy and tolerability of SEP-225289 in subjects with Major Depressive Disorder (MDD) [ Time Frame: 56 days ]
Same as current
Complete list of historical versions of study NCT00584974 on Archive Site
To examine the response to SEP-225289 in MDD subjects meeting DSM_IV criteria for atypical and melancholic features [ Time Frame: 56 days ]
Same as current
Not Provided
Not Provided
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)
To determine the safety, efficacy and tolerability of SEP-225289 in subjects with Major Depressive Disorder
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.
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Depressive Disorder, Major
  • Drug: SEP-225289
    0.5 mg SEP-225289
  • Drug: SEP-225289
    2.0 mg SEP-225289
  • Drug: Venlafaxine
    150 mg Venlafaxine
    Other Name: Effexor
  • Drug: placebo
  • Experimental: 0.5 mg SEP-225289
    0.5 mg SEP-225289
    Intervention: Drug: SEP-225289
  • Experimental: 2.0 mg of SEP-225289
    2.0 mg of SEP-225289
    Intervention: Drug: SEP-225289
  • Active Comparator: Venlafaxine
    150 mg Venlafaxine
    Intervention: Drug: Venlafaxine
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2009
May 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Study Chair: Medical Director, CNS Sunovion
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP