Phase 3 N=513 Randomized Triple-blind Treatment

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

Major Depressive Disorder

Bottom Line

View on ClinicalTrials.gov: NCT01808612 ↗

Enrolled (actual)

513

Serious AEs

0.4%

Results posted

May 2015

Primary outcome: Primary: Mean Change From Baseline to 6-Week Endpoint on the 21-Item Hamilton Depression Rating Scale (HAMD21) Total Score — -6.18; -6.25; -6.91 units on a scale — p=0.264

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Fluoxetine (Drug); Placebo (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: Jul 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change From Baseline to 6-Week Endpoint on the 21-Item Hamilton Depression Rating Scale (HAMD21) Total Score	-6.18; -6.25; -6.91	0.264
SECONDARY Mean Change From Baseline to 6-Week Endpoint on the HAMD21 Subscale Scores	-5.59; -5.61; -6.27; -3.35; -3.39; -3.30	—
SECONDARY Percentage of Participants Achieving a Response at 6-Week Endpoint	23.8; 18.1; 27.8	—
SECONDARY Percentage of Participants Achieving a Remission at 6-Week Endpoint	9.5; 9.6; 15.1	—
SECONDARY Mean Change From Baseline to 6-Week Endpoint on the Clinical Global Impression of Severity (CGI-S) Scale	-0.69; -0.67; -0.81	—
SECONDARY Mean Change From Baseline to 6-Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscale Scores	-1.76; -1.55; -1.99; -0.79; -0.34; -0.88	—
SECONDARY Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)	0; 0; 1; 5; 6; 8	—

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).

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01808612). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.