A Safety, Efficacy and Tolerability Study of SEP-225289

Completed · Phase 2 · Has a placebo group

Conditions studied: Depressive Disorder, Major

In brief

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

Key facts

Study ID

NCT00584974

Run by

Sumitomo Pharma America, Inc.

People needed

523

Starts

2007-12-01

Expected to finish

2009-05-01

Last updated by the study team

2012-02-23

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Arcadia, California, United States
• Study site — Beverly Hills, California, United States
• Study site — Costa Mesa, California, United States
• Study site — Garden Grove, California, United States
• Study site — Glendale, California, United States
• Study site — Irvine, California, United States
• Study site — Lafayette, California, United States
• Study site — Oceanside, California, United States
• Study site — San Diego, California, United States
• Study site — Upland, California, United States
• Study site — Denver, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — New Britain, Connecticut, United States
• Study site — Bradenton, Florida, United States
• Study site — Fort Myers, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Lauderhill, Florida, United States
• Study site — Maitland, Florida, United States
• Study site — North Miami, Florida, United States
• Study site — Sanford, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Atlanta, Georgia, United States
• Study site — Smyrna, Georgia, United States
• Study site — Park Ridge, Illinois, United States
• Study site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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