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A Phase 3, Open-label, Long-Term Study to Evaluate the Safety of LY110140 Once Daily Dosing for 52-week in Japanese Patients With Major Depressive Disorder

A Phase 3, Open-label, Long-Term Study to Evaluate the Safety of LY110140 Once Daily Dosing for 52-week in Japanese Patients With Major Depressive Disorder

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222056
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: -Have completed Study B1Y-JE-HCLV -Agree to abstain from sexual activity or to use a reliable method of birth control

Exclusion criteria

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

Outcome results

None listed

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