A Safety, Efficacy and Tolerability Study of SEP-225289

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunovion
• Treatments: Venlafaxine Hydrochloride

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.