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

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Fluoxetine

Criteria

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