A Study Comparing Duloxetine and Placebo in Assessing Energy and Vitality in Major Depressive Disorder (MDD) Patients

November 17, 2009 updated by: Eli Lilly and Company

Duloxetine Versus Placebo in Patients With Major Depressive Disorder (MDD): Assessment of Energy and Vitality in MDD

Study F1J-US-HMFS comprises two identical multicenter, 9-month, randomized, placebo-controlled, double-blind, trials (HMFSa and HMFSb). The purpose of this study is to compare the efficacy and safety of Duloxetine 60 milligrams (mg) once daily to placebo on depression in patients aged 18-65. Data from the two trials will be reported in both individual and pooled analyses. Pooling the two studies will allow for increased power to detect differences between duloxetine and placebo on secondary and exploratory objectives. Only one data lock is planned for this study, when all patients have completed all study procedures.

Study Overview

Status

Completed

Conditions

Major Depressive Disorder

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

776

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Puerto Rico
- - Arecibo, Puerto Rico, 00612
    - 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.
  - Caguas, Puerto Rico, 00725
    - 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.
  - Ponce, Puerto Rico, 00731
    - 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.
  - San Juan, Puerto Rico, 00907
    - 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.
United States
- California
  - Beverly Hills, California, United States, 90210
    - 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.
  - Escondido, California, United States, 92025
    - 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.
  - National City, California, United States, 91950
    - 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.
- Connecticut
  - Hamden, Connecticut, United States, 06518
    - 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.
  - New Britain, Connecticut, United States, 06050
    - 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.
  - New London, Connecticut, United States, 06320
    - 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.
- Delaware
  - Wilmington, Delaware, United States, 19808
    - 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.
- District of Columbia
  - Washington, District of Columbia, United States, 20037
    - 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.
- Florida
  - Bradenton, Florida, United States, 34208
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  - Fort Myers, Florida, United States, 33912
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  - Gainesville, Florida, United States, 32606
    - 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.
  - Maitland, Florida, United States, 32751
    - 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.
- Georgia
  - Atlanta, Georgia, United States, 30328
    - 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.
- Illinois
  - Edwardsville, Illinois, United States, 62025
    - 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.
  - Hoffman Estates, Illinois, United States, 60169
    - 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.
  - Naperville, Illinois, United States, 60540
    - 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.
  - Oak Brook, Illinois, United States, 60523
    - 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.
- Indiana
  - Lafayette, Indiana, United States, 47905
    - 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.
  - Terre Haute, Indiana, United States, 47802
    - 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.
- Kansas
  - Prairie Village, Kansas, United States, 66206
    - 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.
- Maryland
  - Baltimore, Maryland, United States, 21285
    - 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.
  - Glen Burnie, Maryland, United States, 21061
    - 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.
  - Rockville, Maryland, United States, 20852
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- Massachusetts
  - Belmont, Massachusetts, United States, 02478
    - 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.
  - Pittsfield, Massachusetts, United States, 01201
    - 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.
- Missouri
  - Chesterfield, Missouri, United States, 63017
    - 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.
  - St Louis, Missouri, United States, 63141
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  - St. Peters, Missouri, United States, 63376
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- New Jersey
  - Clementon, New Jersey, United States, 08021
    - 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.
- New York
  - Cedarhurst, New York, United States, 11516
    - 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.
  - New York, New York, United States, 10021
    - 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.
  - Olean, New York, United States, 14760
    - 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.
  - Staten Island, New York, United States, 10305
    - 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.
- Pennsylvania
  - Allentown, Pennsylvania, United States, 18104
    - 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.
  - Media, Pennsylvania, United States, 19063
    - 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.
  - Philadelphia, Pennsylvania, United States, 19104
    - 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.
- Tennessee
  - Memphis, Tennessee, United States, 38119
    - 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.
- Texas
  - Lake Jackson, Texas, United States, 77566
    - 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.
- Virginia
  - Arlington, Virginia, United States, 22201
    - 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.
  - Charlottesville, Virginia, United States, 22903
    - 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.
  - Richmond, Virginia, United States, 23230
    - 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.
- Wisconsin
  - Brown Deer, Wisconsin, United States, 53223
    - 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.
  - West Allis, Wisconsin, United States, 53227
    - 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Male or female outpatients
Aged 18-65 who meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for Major Depressive Disorder (MDD)
Have a Montgomery-Asberg Depression Rating Scale (MADRS) total score of at least 22 at visits 1 and 2
Have a Clinical Global Impressions of Severity Scale (CGI-S) score of at least 4 at visits 1 and 2
Have a degree of understanding such that the patient can provide informed consent, complete protocol required assessments and communicate intelligibly with the investigator and study coordinator.

Exclusion Criteria:

Patients judged clinically to be at serious suicidal risk in the opinion of the investigator
Patients who have any prior history of bipolar disorder, psychosis, or schizophrenia
Patients who have any current (within the past six months) DSM-IV-TR primary Axis I disorder other than MDD
Patients with uncontrolled narrow-angle glaucoma
Patients who have a serious medical illness that is in the opinion of the investigator not stabilized or is likely to require intervention, hospitalization, or use of an excluded medication during the course of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A duloxetine 60 milligrams (mg) every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months	Drug: Duloxetine hydrochloride Other Names: Cymbalta LY248686
Placebo Comparator: B placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to 8 Weeks in 24-Item Hamilton Depression Rating Scale (HAMD-24) Item 7 (Work and Activities) Time Frame: baseline, 8 weeks	Item 7 of the HAMD-24 assesses loss of interest or pleasure in work and activities and is an essential symptom in MDD. Scores range from 0 (no difficulty/no loss) to 4 (difficulty/loss).	baseline, 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) Time Frame: Baseline, 8 weeks, 12 weeks, 9 months	The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). Please see baseline demographics for subscale total scores.	Baseline, 8 weeks, 12 weeks, 9 months
Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Total Score Time Frame: Baseline, 12 weeks, 9 months		Baseline, 12 weeks, 9 months
Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Item 1:Depressed Mood Time Frame: Baseline, 12 weeks, 9 months	Measures depressed mood on a scale of 0 (absent) to 4 (very depressed).	Baseline, 12 weeks, 9 months
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 2:Feelings of Guilt Time Frame: Baseline, 12 weeks, 9 months	Measures feelings of guilt on a scale of 0 (absent) to 4 (very guilty).	Baseline, 12 weeks, 9 months
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 3:Suicide Time Frame: Baseline, 12 weeks, 9 Months	Measures thoughts of suicide on a scale of 0 (absent) to 4 (attempts suicide).	Baseline, 12 weeks, 9 Months
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 4:Insomnia Early Time Frame: Baseline, 12 weeks, 9 months	Measures early insomnia on a scale of 0 (no difficulty falling asleep) to 2 (complains of nightly difficulty falling asleep).	Baseline, 12 weeks, 9 months
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 5:Insomnia Middle Time Frame: Baseline, 12 weeks, 9 months	Measures middle insomnia on a scale of 0 (no difficulty) to 2 (waking during the night).	Baseline, 12 weeks, 9 months
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 6:Insomnia Late Time Frame: Baseline, 12 weeks, 9 months	Measures late insomnia on a scale of 0 (no difficulty) to 2 (unable to fall asleep again if gets out of bed).	Baseline, 12 weeks, 9 months
Change From Baseline to 9 Month Endpoint in HAMD-24 - Item 7:Work and Activities Time Frame: Baseline, 9 months	Item 7 of the HAMD-24 assesses loss of interest or pleasure in work and activities and is an essential symptom in MDD. Scores range from 0 (no difficulty/no loss) to 4 (difficulty/loss).	Baseline, 9 months
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 8:Retardation Time Frame: Baseline, 12 weeks, 9 months	Measures slowness of thought and speech; impaired ability to concentrate; decreased motor activity on a scale of 0 (normal speech and thought) to 4 (complete stupor).	Baseline, 12 weeks, 9 months
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 9:Agitation Time Frame: Baseline, 12 weeks, 9 months	Measures agitation on a scale of 0 (none) to 4 (hand-wringing, nail-biting)	Baseline, 12 weeks, 9 months
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 10:Anxiety (Psychic) Time Frame: Baseline, 12 weeks, 9 months	Measures anxiety on a scale of 0 (no difficulty) to 4 (fears expressed)	Baseline, 12 weeks, 9 months
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 11:Anxiety (Somatic) Time Frame: Baseline, 12 weeks, 9 months	Measures physiological concomitants of anxiety on a scale of 0 (absent) to 4 (incapacitating).	Baseline, 12 weeks, 9 months
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 12:Somatic Symptoms/Gastrointestinal Time Frame: Baseline, 12 weeks, 9 months	Measures gastrointestical somatic symptoms on a scale of 0 (none) to 2 (difficulty eating, requires medication for symptoms).	Baseline, 12 weeks, 9 months
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 13:Somatic Symptoms/General Time Frame: Baseline, 12 weeks, 9 months	Measures general somatic symptoms on a scale of 0 (none) to 2 (any clear-cut symptoms).	Baseline, 12 weeks, 9 months
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 14:Genital Symptoms Time Frame: Baseline, 12 weeks, 9 months	Measures genital symptoms (loss of libido, menstrual disturbances) on a scale of 0 (absent) to 2 (severe).	Baseline, 12 weeks, 9 months
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 15:Hypochondriasis Time Frame: Baseline, 12 weeks, 9 months	Measures hypochondriasis on a scale of 0 (not present) to 4 (hypochondriacal delusions).	Baseline, 12 weeks, 9 months
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 16:Loss of Weight Time Frame: Baseline, 12 weeks, 9 months	Measures weight loss since last visit on a scale of 0 (no weight loss) to 2 (definite weight loss caused by present illness).	Baseline, 12 weeks, 9 months
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 17:Insight Time Frame: Baseline, 12 weeks, 9 months	Measures insight on a scale of 0 (acknowledges being depressed and ill) to 2 (denies being ill at all).	Baseline, 12 weeks, 9 months
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18A:Diurnal Variation Time Frame: Baseline, 12 weeks, 9 months	Measures whether symptoms are worse in morning or evening on a scale of 0 (no variation), 1 (worse in morning), or 2 (worse in evening).	Baseline, 12 weeks, 9 months
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18B:Diurnal Variation-Severity Time Frame: Baseline, 12 weeks, 9 months	Measures the severity of the diurnal variation on a scale of 0 (none) to 2 (severe).	Baseline, 12 weeks, 9 months
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 19: Depersonalization and Derealization Time Frame: Baseline, 12 weeks, 9 months	Measures feelings of unreality on a scale of 0 (absent) to 4 (incapacitating).	Baseline, 12 weeks, 9 months
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 20:Paranoid Symptoms Time Frame: Baseline, 12 weeks, 9 months	Measures paranoid symptoms on a scale of 0 (none) to 2 (severe).	Baseline, 12 weeks, 9 months
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 21:Obsessional and Compulsive Symptoms Time Frame: Baseline, 12 weeks, 9 months	Measures obsessional and compulsive symptoms on a scale of 0 (absent) to 2 (severe).	Baseline, 12 weeks, 9 months
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 22B:Helplessness Time Frame: Baseline, 12 weeks, 9 months	Measures feelings of helplessness on a scale of 0 (absent) to 4 (severe).	Baseline, 12 weeks, 9 months
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 23B:Hopelessness Time Frame: Baseline, 12 weeks, 9 months	Measures feelings of hopelessness on a scale of 0 (absent) to 4 (expresses feelings of discouragement, despair, and/or pessimism about the future which cannot be dispelled).	Baseline, 12 weeks, 9 months
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 24B:Worthlessness Time Frame: Baseline, 12 weeks, 9 months	Measures feelings of worthlessness on a scale of 0 (absent) to 4 (severe).	Baseline, 12 weeks, 9 months
Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment). Time Frame: Baseline, 12 weeks	The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety, depression-dejection, anxiety-hostility, fatigue, confusion, and vigor. Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0 to 20. The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig).	Baseline, 12 weeks
Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment) Time Frame: Baseline, 9 months	The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety, depression-dejection, anxiety-hostility, fatigue, confusion, and vigor. Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0 to 20. The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig).	Baseline, 9 months
Change From Baseline to 12 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores Time Frame: Baseline, 12 weeks	The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Individual item scores range from 0 to 10. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life.	Baseline, 12 weeks
Change From Baseline to 9 Month Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores Time Frame: Baseline, 9 months	The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Individual item scores range from 0 to 10. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life.	Baseline, 9 months
Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 Time Frame: Over 12 weeks	Relative contribution of improvement on the mood states, defined by BPOMS total score (calculated from subscales) to overall improvement in work and activities, HAMD-24 item 7 using path analysis.	Over 12 weeks
Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 - Percent of Total Effect Time Frame: over 12 weeks	For Group A, at least one effect was in the opposite direction, percent of total effect was not calculated.	over 12 weeks
Path Analysis of BPOMS Total Score to Overall Improvement in Sheehan Disability Scale (SDS) Total Score Time Frame: over 12 weeks	Relative contribution of improvement on the mood states, defined by BPOMS total score (determined from subscales) to overall improvement in SDS total score using path analysis.	over 12 weeks
Path Analysis of BPOMS Total Score to Overall Improvement in SDS Total Score - Percent of Total Effect Time Frame: Over 12 weeks	For Group A, at least one effect was in the opposite direction, percent of total effect was not calculated.	Over 12 weeks
Change From Baseline to 12 Week and 9 Month Endpoints in 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) Total Score Time Frame: Baseline, 12 weeks, 9 months	A 16-item patient-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity.	Baseline, 12 weeks, 9 months
Probability of Remission at 12 Week Endpoint and Sustained Remission at 9 Month Endpoint Time Frame: 12 weeks, 9 months	Probability of remission as measured by the HAMD17 Total Score ≤ 7 and by the QIDS16SR Total Score ≤ 5. The visitwise percentages of patients meeting criteria in the Acute Therapy Phase for remission (visitwise binary outcome, yes/no) will be analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis will include the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score.	12 weeks, 9 months
Probability of Response at 12 Week Endpoint Time Frame: 12 weeks	Probability of response as measured by ≥ 50% Improvement in the HAMD17 Total Score and ≥ 50% Improvement in the QIDS16SR Total Score. The visitwise percentages of patients meeting criteria in the Acute Therapy Phase for response (visitwise binary outcome, yes/no) will be analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis will include the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score.	12 weeks
Change From Baseline to 12 Week and 9 Month Endpoints in Pain Numerical Rating Scale (NRS) Time Frame: Baseline, 12 weeks, 9 months	Item 1=Average musculoskeletal pain severity over the last week as measured by an 11-point Likert scale. Scores range from 0 (no pain) to 10 (worst possible pain). Item 7=How much they have been bothered by pain over the last week. Scores range from 0 (not bothered at all)to 10 (extremely bothered).	Baseline, 12 weeks, 9 months
Change From Baseline to 12 Week and 9 Month Endpoint in the Clinical Global Impression-Severity Scale (CGI-S) Time Frame: Baseline, 12 weeks, 9 months	Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.	Baseline, 12 weeks, 9 months
Change From Baseline to 12 Week and 9 Month Endpoints in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Time Frame: Baseline, 12 weeks, 9 months	A 7-item patitent-rated questionnaire pertaining to a patient's cognitive and physical well-being. It assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each of the 7 questions is scored on a 6-point scale ranging fom 1 (greater than normal) to 6 (totally absent). Total score ranges from 7 to 42.	Baseline, 12 weeks, 9 months
Change From Baseline to 12 Week and 9 Month Endpoints in the Social Adaptation Self-evaluation Scale (SASS) Total Score Time Frame: Baseline, 12 weeks, 9 months	A 21-item self-rated scale that evaluates patient social motivation and behavior in depression. Each of the 21 items is scored from 0 (minimal social adjustment) to 3 (maximal social adjustment). Total score ranges from 0 to 60.	Baseline, 12 weeks, 9 months
Change From Baseline to 12 Week and 9 Month Endpoints in Blood Pressure Time Frame: Baseline, 12 weeks, 9 months	Sitting systolic and diastolic blood pressure.	Baseline, 12 weeks, 9 months
Change From Baseline to 12 Week and 9 Month Endpoints in Pulse Rate Time Frame: Baseline, 12 weeks, 9 months		Baseline, 12 weeks, 9 months
Change From Baseline to 12 Week and 9 Month Endpoints in Weight Time Frame: Baseline, 12 weeks, 9 months		Baseline, 12 weeks, 9 months
Abnormal Vital Signs at Anytime Over 12 Weeks Time Frame: over 12 weeks		over 12 weeks
Abnormal Vital Signs at Anytime Over 9 Months Time Frame: over 9 months		over 9 months
Abnormal Vital Signs at 12 Week Endpoint Time Frame: 12 weeks		12 weeks
Abnormal Vital Signs at 9 Month Endpoint Time Frame: 9 months		9 months
Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Bilirubin, Creatinine, Uric Acid Time Frame: Baseline, 12 weeks, 9 months		Baseline, 12 weeks, 9 months
Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Hematocrit Time Frame: Baseline, 12 weeks, 9 months		Baseline, 12 weeks, 9 months
Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Mean Cell Volume (MCV) Time Frame: Baseline, 12 weeks, 9 months		Baseline, 12 weeks, 9 months
Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Chloride, Urea Nitrogen, Cholesterol, Sodium Time Frame: Baseline, 12 weeks, 9 months		Baseline, 12 weeks, 9 months
Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Platelet Count Time Frame: Baseline, 12 weeks, 9 months		Baseline, 12 weeks, 9 months
Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Alkaline Phosphatase Time Frame: baseline, 9 months		baseline, 9 months
Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Hemoglobin Time Frame: Baseline, 9 months		Baseline, 9 months
Statistically Significant Abnormal Laboratory Values at Anytime/12 Week Endpoint Time Frame: over 3 months	The number of participants with statistically significant abnormal lab values at anytime and at 12 week endpoint were the same.	over 3 months
Statistically Significant Abnormal Laboratory Values at Anytime During 9 Months Time Frame: over 9 months		over 9 months
Statistically Significant Abnormal Laboratory Values at 9 Month Endpoint Time Frame: 9 months		9 months
Summary of Adverse Events Leading to Discontinuation Time Frame: over 9 months		over 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Lilly Clinical Trial Registry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

September 25, 2007

First Submitted That Met QC Criteria

September 25, 2007

First Posted (Estimate)

September 27, 2007

Study Record Updates

Last Update Posted (Estimate)

November 20, 2009

Last Update Submitted That Met QC Criteria

November 17, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

11669 (Registry Identifier: DAIDS ES Registry Number)
F1J-US-HMFS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

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Primary Outcome Measures

Outcome Measure

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Secondary Outcome Measures

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Sponsor

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Major Depressive Disorder

Clinical Trials on Placebo

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