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

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the short-term efficacy and safety of Fluoxetine in Japanese adult participants with Major Depressive Disorder (MDD).

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

Details

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

Criteria

Inclusion Criteria:

• Outpatient Japanese participants diagnosed with MDD

• Diagnosis of moderate or greater severity of MDD

• Agree to abstain from sexual activity or to use a reliable method of birth control

• Judged to be reliable (agree to keep appointments for clinic visits and to undergo all tests and examinations required by the protocol)

Exclusion Criteria:

• Have previously been exposed to fluoxetine (LY110140) for any indication in the past

• 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

• Have initiated, stopped, or changed the type or intensity of psychotherapy within 6 weeks

• Have a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or vagus nerve stimulation (VNS) within 1 year

• Have had treatment with a Monoamine oxidase inhibitor (MAOI) within 14 days

• Need to use thioridazine or pimozide during the study

• Have previously enrolled, completed, or withdrawn from this study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 a history of seizure disorder

• 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