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
- Conditions
- Major Depressive Disorder
- Registration Number
- JPRN-jRCT2080222056
- Lead Sponsor
- Eli Lilly Japan K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Have completed Study B1Y-JE-HCLV
-Agree to abstain from sexual activity or to use a reliable method of birth control
-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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method