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

Eli Lilly and Company200 enrolled

Overview

This study will evaluate the safety and effectiveness of fluoxetine flexible dosing in the treatment of MDD in adult Japanese participants. Participants who complete the short-term treatment phase of Study B1Y-JE-HCLV (NCT#: NCT01808612) will be allowed to enroll in this study, and receive fluoxetine treatment for an additional 52 weeks.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Major Depressive Disorder

Interventions

FluoxetineDRUG

Administered orally

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Have completed Study B1Y-JE-HCLV (NCT#:NCT01808612) * Agree to abstain from sexual activity or to use a reliable method of birth control 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

Locations (16)

Outcomes

Primary Outcomes

Number of Participants With Adverse Events (AEs) or Serious AEs (SAEs)

Time frame: Baseline through Week 52.

Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)

C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation.

Time frame: Baseline through Week 52

Secondary Outcomes

Mean Change From Baseline to Week 52 on the 21-Item Hamilton Depression Rating Scale (HAMD21) Total Score

HAMD21 is a 21-item assessment used to measure depression severity. Items were rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score ranging from 0 (not at all depressed) to 64 (severely depressed). Least squares (LS) means were calculated using mixed-model repeated measures (MMRM) adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline HAMD21 total score.

Time frame: Baseline, Week 52

Percentage of Participants Achieving a Response at Week 52

The percentage of participants achieving a response (defined as a ≥50% improvement from baseline on the HAMD21 total score) was calculated by dividing the number of participants achieving a response at last observation by the total number of participants at risk, multiplied by 100.

Time frame: Baseline, up to Week 52

Percentage of Participants Achieving a Remission at Week 52

Data from ClinicalTrials.gov

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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

Chiba, Japan

Fukuoka, Japan

Fukushima, Japan

Hiroshima, Japan

Hokkaido, Japan

Hyōgo, Japan

Kanagawa, Japan

Kyoto, Japan

Nagano, Japan

...and 6 more locations

Mean Change From Baseline to Week 52 on the HAMD21 Subscale Scores

HAMD17 total scores and subscale scores from the HAMD21 are presented. HAMD17 is a 17-item assessment of depression severity (total scores range from 0-52). The Maier subscale (Items 1, 2, 7-10) represents the core symptoms of depression (0-24). Anxiety/Somatization subscale (Items 10-13, 15, 17) evaluates severity of psychic and somatic manifestations of anxiety as well as agitation (0-18). Retardation/Somatization subscale (Items 1, 7, 8, 14) evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation (0-14). Sleep subscale (Items 4-6) assesses insomnia (0-6). Individual item scores may range from 0-4 or 0-2. Higher scores indicate more severe symptoms. LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline score.

Time frame: Baseline, Week 52