Conditions

Outcome Measures

Mean Change From Baseline to 6-Week Endpoint on the 21-Item Hamilton Depression Rating Scale (HAMD21) Total Score
HAMD21 is a 21-item assessment used to measure depression severity. Items were rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score ranging from 0 (not at all depressed) to 64 (severely depressed). Least squares (LS) means were calculated using mixed-model repeated measures (MMRM) adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline HAMD21 total score.
Baseline, 6 weeks

Mean Change From Baseline to 6-Week Endpoint on the HAMD21 Subscale Scores
Baseline, 6 weeks
Percentage of Participants Achieving a Response at 6-Week Endpoint
up to 6 weeks
Percentage of Participants Achieving a Remission at 6-Week Endpoint
up to 6 weeks
Mean Change From Baseline to 6-Week Endpoint on the Clinical Global Impression of Severity (CGI-S) Scale
Baseline, 6 weeks
Mean Change From Baseline to 6-Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscale Scores
Baseline, up to 6 weeks
+1 more secondary outcomes

EXPERIMENTAL

20 milligrams (mg) fluoxetine (capsules) administered orally, once daily, for 6 weeks

Drug: Fluoxetine

EXPERIMENTAL

40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks

Drug: Fluoxetine

PLACEBO COMPARATOR

Placebo (capsules) administered orally, once daily, for 6 weeks

Drug: Placebo

Also known as: LY110140, Fluoxetine Hydrochloride, Prozac, Sarafem

20 mg Fluoxetine40 mg Fluoxetine

Placebo

Age20 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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)

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

Contact the study team to confirm eligibility.