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

Last updated: April 24, 2015
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

3

Condition

Mood Disorders

Depression (Major/severe)

Affective Disorders

Treatment

N/A

Clinical Study ID

NCT01808612
14595
B1Y-JE-HCLV
  • Ages > 20
  • All Genders

Study 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

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 alltests and examinations required by the protocol)

Exclusion

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 compulsivedisorder, or post-traumatic stress disorder

  • Have a history of substance abuse or dependence within the past 6 months, excludingcaffeine and nicotine

  • Have initiated, stopped, or changed the type or intensity of psychotherapy within 6weeks

  • 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  • Have previously enrolled, completed, or withdrawn from this study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, ormale 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 otherreasons

Study Design

Total Participants: 513
Study Start date:
March 01, 2013
Estimated Completion Date:
July 31, 2014

Connect with a study center

  • 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, 471-8513
    Japan

    Site Not Available

  • 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, 270-0014
    Japan

    Site Not Available

  • 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, 800-0226
    Japan

    Site Not Available

  • 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, 961-0021
    Japan

    Site Not Available

  • 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.

    Hiroshima, 737-0143
    Japan

    Site Not Available

  • 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.

    Hokkaido, 065-0012
    Japan

    Site Not Available

  • 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.

    Hyogo, 651-0097
    Japan

    Site Not Available

  • 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.

    Kanagawa, 238-0042
    Japan

    Site Not Available

  • 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.

    Kyoto, 616-8421
    Japan

    Site Not Available

  • 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.

    Nagano, 390-0303
    Japan

    Site Not Available

  • 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.

    Okayama, 700-0907
    Japan

    Site Not Available

  • 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.

    Osaka, 586-0012
    Japan

    Site Not Available

  • 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.

    Saitama, 339-0057
    Japan

    Site Not Available

  • 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.

    Shiga, 525-0037
    Japan

    Site Not Available

  • 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.

    Tochigi, 321-0953
    Japan

    Site Not Available

  • 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.

    Tokyo, 170-0002
    Japan

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.