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)
Verified date | February 2012 |
Source | Sunovion |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
To determine the safety, efficacy and tolerability of SEP-225289 in subjects with Major Depressive Disorder
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sunovion |
United States,
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 |
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