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

Lilly

Status and phase

Completed

Phase 3

Conditions

Major Depressive Disorder

Treatments

Drug: Fluoxetine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01808651

14596

B1Y-JE-HCLW (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

200 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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