A Study of Fluoxetine in Major Depressive Disorder (MDD) Long-Term Dosing

A Phase 3, Open-label, Long-Term Study to Evaluate the Safety of LY110140 Once Daily Dosing for 52-week in Japanese Patients With Major Depressive Disorder

This study will evaluate the safety and effectiveness of fluoxetine flexible dosing in the treatment of MDD in adult Japanese participants.

Participants who complete the short-term treatment phase of Study B1Y-JE-HCLV (NCT#: NCT01808612) will be allowed to enroll in this study, and receive fluoxetine treatment for an additional 52 weeks.

Inclusion Criteria:

• Have completed Study B1Y-JE-HCLV (NCT#:NCT01808612)
• Agree to abstain from sexual activity or to use a reliable method of birth control

Exclusion Criteria:

• Significant suicidal risk
• Have a current or previous diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive disorder, or post-traumatic stress disorder
• Have a history of substance abuse or dependence within the past 6 months, excluding caffeine and nicotine
• Need to use thioridazine or pimozide during the study
• Have a positive urine drug screen for drugs with abuse potential
• Female participants who are either pregnant, nursing, or have recently given birth, or male participants who are planning for their partners to be or become pregnant
• Have frequent or severe allergic reactions to multiple medications
• Have a serious or unstable medical illness or condition, or psychological condition
• Participants deemed ineligible by the investigator or sub-investigator for other reasons