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)”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2008

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).

Intervention(s) in this Clinical Trial

• Drug: SEP-225289
  • 0.5 mg SEP-225289
• Drug: SEP-225289
  • 2.0 mg SEP-225289
• Drug: Venlafaxine
  • 150 mg Venlafaxine
• Drug: placebo
  • Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 0.5 mg SEP-225289
• Experimental: 2
  • 2.0 mg of SEP-225289
• Active Comparator: 3
  • 150 mg Venlafaxine
• Placebo Comparator: 4
  • placebo

Primary Measures

• To assess the safety, efficacy and tolerability of SEP-225289 in subjects with Major Depressive Disorder (MDD)
  • Time Frame: 56 days
    Safety Issue?: Yes

Secondary Measures

• To examine the response to SEP-225289 in MDD subjects meeting DSM_IV criteria for atypical and melancholic features
  • Time Frame: 56 days
    Safety Issue?: No

Inclusion Criteria:

• The duration of the current episode must be at least 1 month but not longer than 6 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 who is a current smoker, or has smoked within the last 12 months.
• 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sepracor, Inc.

Overall Clinical Trial Officials and Contacts

Medical Director, CNS Study Chair Sepracor, Inc.  

Overall Contact: Sepracor Central Contact 866-503-6351 

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00584974

Study ID Number: 360-029

ClinicalTrials.gov Identifier: NCT00584974

Health Authority: United States: Food and Drug Administration