A Safety, Efficacy and Tolerability Study of SEP-225289

Depressive Disorder, Major Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00584974
• Other study ID #: 360-029
• Status: Completed
• Phase: Phase 2
• First received: December 21, 2007
• Last updated: February 21, 2012
• Start date: December 2007
• Est. completion date: May 2009

Study information

• Verified date: February 2012
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 523
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety, efficacy and tolerability of SEP-225289 in subjects with Major Depressive Disorder (MDD)		56 days	Yes
Secondary	To examine the response to SEP-225289 in MDD subjects meeting DSM_IV criteria for atypical and melancholic features		56 days	No