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A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Parallel-Design Study to Evaluate the Short-Term, Fixed Dose Efficacy and Safety of LY110140 Once Daily Dosing in Japanese Patients With Major Depressive Disorder

A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Parallel-Design Study to Evaluate the Short-Term, Fixed Dose Efficacy and Safety of LY110140 Once Daily Dosing in Japanese Patients With Major Depressive Disorder

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222055
Enrollment
Unknown
Registered
2013-04-01
Start date
2013-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Interventions

investigational material(s) Generic name etc : Fluoxetine INN of investigational material : Therapeutic category code : 117 Psychotropic agents Dosage and Administration for Investigational material

Sponsors

Eli Lilly Japan K.K.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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(MAOI) within 14 days -Need to use thioridazine or pimozide during the study -Have previously enrolled, completed, or withdrawn from this study -Have a positive urine drug screen for drugs with abuse potential -Female participants who are either pregnant, nursing, or have recently given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

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026