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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):

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

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: SEP-225289 Drug: Venlafaxine Drug: placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 523 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : December 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 0.5 mg SEP-225289
0.5 mg SEP-225289
Drug: SEP-225289
0.5 mg SEP-225289

Experimental: 2.0 mg of SEP-225289
2.0 mg of SEP-225289
Drug: SEP-225289
2.0 mg SEP-225289

Active Comparator: Venlafaxine
150 mg Venlafaxine
Drug: Venlafaxine
150 mg Venlafaxine
Other Name: Effexor

Placebo Comparator: Placebo
Drug: placebo

Primary Outcome Measures :
  1. To assess the safety, efficacy and tolerability of SEP-225289 in subjects with Major Depressive Disorder (MDD) [ Time Frame: 56 days ]

Secondary Outcome Measures :
  1. To examine the response to SEP-225289 in MDD subjects meeting DSM_IV criteria for atypical and melancholic features [ Time Frame: 56 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00584974

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Sponsors and Collaborators
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Study Chair: Medical Director, CNS Sunovion

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Responsible Party: Sunovion Identifier: NCT00584974     History of Changes
Other Study ID Numbers: 360-029
First Posted: January 2, 2008    Key Record Dates
Last Update Posted: February 23, 2012
Last Verified: February 2012

Keywords provided by Sunovion:
Mental Disorders
Mood Disorders
Depressive Disorder, Major
Dysthymic Disorder

Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Venlafaxine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs