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A Safety, Efficacy and Tolerability Study of SEP-225289

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00584974
First received: December 21, 2007
Last updated: February 21, 2012
Last verified: February 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Depressive Disorder, Major
 Drug: SEP-225289
Drug: Venlafaxine
Drug: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sunovion:

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

Secondary Outcome Measures:
  • To examine the response to SEP-225289 in MDD subjects meeting DSM_IV criteria for atypical and melancholic features [ Time Frame: 56 days ] [ Designated as safety issue: No ]

Enrollment: 523
Study Start Date: December 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
placebo
 Drug: placebo
Placebo

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584974

  Show 51 Study Locations
Sponsors and Collaborators
Sunovion
Investigators
Study Chair: Medical Director, CNS Sunovion
  More Information

No publications provided

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00584974     History of Changes
Other Study ID Numbers: 360-029
Study First Received: December 21, 2007
Last Updated: February 21, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Venlafaxine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013