Status:
COMPLETED
A Study of Fluoxetine in Major Depressive Disorder (MDD) Short-Term Dosing
Lead Sponsor:
Eli Lilly and Company
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief 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
- 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
- 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- Have previously enrolled, completed, or withdrawn from this study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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
513 Patients enrolled
Trial Details
Trial ID
NCT01808612
Start Date
March 1 2013
End Date
July 1 2014
Last Update
May 12 2015
Active Locations (16)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Aichi, Japan, 471-8513
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chiba, Japan, 270-0014
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fukuoka, Japan, 800-0226
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fukushima, Japan, 961-0021