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

Primary Purpose

Major Depressive Disorder

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Duloxetine hydrochloride

Placebo

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change From Baseline to 8 Weeks in 24-Item Hamilton Depression Rating Scale (HAMD-24) Item 7 (Work and Activities)

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).

Secondary Outcome Measures

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)

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.

Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Total Score

Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Item 1:Depressed Mood

Measures depressed mood on a scale of 0 (absent) to 4 (very depressed).

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 2:Feelings of Guilt

Measures feelings of guilt on a scale of 0 (absent) to 4 (very guilty).

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 3:Suicide

Measures thoughts of suicide on a scale of 0 (absent) to 4 (attempts suicide).

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 4:Insomnia Early

Measures early insomnia on a scale of 0 (no difficulty falling asleep) to 2 (complains of nightly difficulty falling asleep).

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 5:Insomnia Middle

Measures middle insomnia on a scale of 0 (no difficulty) to 2 (waking during the night).

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 6:Insomnia Late

Measures late insomnia on a scale of 0 (no difficulty) to 2 (unable to fall asleep again if gets out of bed).

Change From Baseline to 9 Month Endpoint in HAMD-24 - Item 7:Work and Activities

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).

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 8:Retardation

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).

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 9:Agitation

Measures agitation on a scale of 0 (none) to 4 (hand-wringing, nail-biting)

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 10:Anxiety (Psychic)

Measures anxiety on a scale of 0 (no difficulty) to 4 (fears expressed)

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 11:Anxiety (Somatic)

Measures physiological concomitants of anxiety on a scale of 0 (absent) to 4 (incapacitating).

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 12:Somatic Symptoms/Gastrointestinal

Measures gastrointestical somatic symptoms on a scale of 0 (none) to 2 (difficulty eating, requires medication for symptoms).

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 13:Somatic Symptoms/General

Measures general somatic symptoms on a scale of 0 (none) to 2 (any clear-cut symptoms).

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 14:Genital Symptoms

Measures genital symptoms (loss of libido, menstrual disturbances) on a scale of 0 (absent) to 2 (severe).

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 15:Hypochondriasis

Measures hypochondriasis on a scale of 0 (not present) to 4 (hypochondriacal delusions).

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 16:Loss of Weight

Measures weight loss since last visit on a scale of 0 (no weight loss) to 2 (definite weight loss caused by present illness).

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 17:Insight

Measures insight on a scale of 0 (acknowledges being depressed and ill) to 2 (denies being ill at all).

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18A:Diurnal Variation

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).

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18B:Diurnal Variation-Severity

Measures the severity of the diurnal variation on a scale of 0 (none) to 2 (severe).

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 19: Depersonalization and Derealization

Measures feelings of unreality on a scale of 0 (absent) to 4 (incapacitating).

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 20:Paranoid Symptoms

Measures paranoid symptoms on a scale of 0 (none) to 2 (severe).

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 21:Obsessional and Compulsive Symptoms

Measures obsessional and compulsive symptoms on a scale of 0 (absent) to 2 (severe).

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 22B:Helplessness

Measures feelings of helplessness on a scale of 0 (absent) to 4 (severe).

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 23B:Hopelessness

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).

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 24B:Worthlessness

Measures feelings of worthlessness on a scale of 0 (absent) to 4 (severe).

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).

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).

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)

Change From Baseline to 12 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores

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.

Change From Baseline to 9 Month Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores

Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7

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.

Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 - Percent of Total Effect

For Group A, at least one effect was in the opposite direction, percent of total effect was not calculated.

Path Analysis of BPOMS Total Score to Overall Improvement in Sheehan Disability Scale (SDS) Total Score

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.

Path Analysis of BPOMS Total Score to Overall Improvement in SDS Total Score - Percent of Total Effect

For Group A, at least one effect was in the opposite direction, percent of total effect was not calculated.

Change From Baseline to 12 Week and 9 Month Endpoints in 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) Total Score

A 16-item patient-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity.

Probability of Remission at 12 Week Endpoint and Sustained Remission at 9 Month Endpoint

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.

Probability of Response at 12 Week Endpoint

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.

Change From Baseline to 12 Week and 9 Month Endpoints in Pain Numerical Rating Scale (NRS)

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).

Change From Baseline to 12 Week and 9 Month Endpoint in the Clinical Global Impression-Severity Scale (CGI-S)

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.

Change From Baseline to 12 Week and 9 Month Endpoints in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ)

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.

Change From Baseline to 12 Week and 9 Month Endpoints in the Social Adaptation Self-evaluation Scale (SASS) Total Score

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.

Change From Baseline to 12 Week and 9 Month Endpoints in Blood Pressure

Sitting systolic and diastolic blood pressure.

Change From Baseline to 12 Week and 9 Month Endpoints in Pulse Rate

Change From Baseline to 12 Week and 9 Month Endpoints in Weight

Abnormal Vital Signs at Anytime Over 12 Weeks

Abnormal Vital Signs at Anytime Over 9 Months

Abnormal Vital Signs at 12 Week Endpoint

Abnormal Vital Signs at 9 Month Endpoint

Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Bilirubin, Creatinine, Uric Acid

Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Hematocrit

Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Mean Cell Volume (MCV)

Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Chloride, Urea Nitrogen, Cholesterol, Sodium

Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Platelet Count

Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Alkaline Phosphatase

Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Hemoglobin

Statistically Significant Abnormal Laboratory Values at Anytime/12 Week Endpoint

The number of participants with statistically significant abnormal lab values at anytime and at 12 week endpoint were the same.

Statistically Significant Abnormal Laboratory Values at Anytime During 9 Months

Statistically Significant Abnormal Laboratory Values at 9 Month Endpoint

Summary of Adverse Events Leading to Discontinuation

Full Information

NCT ID

NCT00536471

First Posted

September 25, 2007

Last Updated

November 17, 2009

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00536471

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

776 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Duloxetine hydrochloride

Other Intervention Name(s)

LY248686, Cymbalta

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Change From Baseline to 8 Weeks in 24-Item Hamilton Depression Rating Scale (HAMD-24) Item 7 (Work and Activities)

Description

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).

Time Frame

baseline, 8 weeks

Secondary Outcome Measure Information:

Title

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)

Description

Time Frame

Baseline, 8 weeks, 12 weeks, 9 months

Title

Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Total Score

Time Frame

Baseline, 12 weeks, 9 months

Title

Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Item 1:Depressed Mood

Description

Measures depressed mood on a scale of 0 (absent) to 4 (very depressed).

Time Frame

Baseline, 12 weeks, 9 months

Title

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 2:Feelings of Guilt

Description

Measures feelings of guilt on a scale of 0 (absent) to 4 (very guilty).

Time Frame

Baseline, 12 weeks, 9 months

Title

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 3:Suicide

Description

Measures thoughts of suicide on a scale of 0 (absent) to 4 (attempts suicide).

Time Frame

Baseline, 12 weeks, 9 Months

Title

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 4:Insomnia Early

Description

Measures early insomnia on a scale of 0 (no difficulty falling asleep) to 2 (complains of nightly difficulty falling asleep).

Time Frame

Baseline, 12 weeks, 9 months

Title

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 5:Insomnia Middle

Description

Measures middle insomnia on a scale of 0 (no difficulty) to 2 (waking during the night).

Time Frame

Baseline, 12 weeks, 9 months

Title

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 6:Insomnia Late

Description

Measures late insomnia on a scale of 0 (no difficulty) to 2 (unable to fall asleep again if gets out of bed).

Time Frame

Baseline, 12 weeks, 9 months

Title

Change From Baseline to 9 Month Endpoint in HAMD-24 - Item 7:Work and Activities

Description

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).

Time Frame

Baseline, 9 months

Title

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 8:Retardation

Description

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).

Time Frame

Baseline, 12 weeks, 9 months

Title

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 9:Agitation

Description

Measures agitation on a scale of 0 (none) to 4 (hand-wringing, nail-biting)

Time Frame

Baseline, 12 weeks, 9 months

Title

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 10:Anxiety (Psychic)

Description

Measures anxiety on a scale of 0 (no difficulty) to 4 (fears expressed)

Time Frame

Baseline, 12 weeks, 9 months

Title

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 11:Anxiety (Somatic)

Description

Measures physiological concomitants of anxiety on a scale of 0 (absent) to 4 (incapacitating).

Time Frame

Baseline, 12 weeks, 9 months

Title

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 12:Somatic Symptoms/Gastrointestinal

Description

Measures gastrointestical somatic symptoms on a scale of 0 (none) to 2 (difficulty eating, requires medication for symptoms).

Time Frame

Baseline, 12 weeks, 9 months

Title

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 13:Somatic Symptoms/General

Description

Measures general somatic symptoms on a scale of 0 (none) to 2 (any clear-cut symptoms).

Time Frame

Baseline, 12 weeks, 9 months

Title

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 14:Genital Symptoms

Description

Measures genital symptoms (loss of libido, menstrual disturbances) on a scale of 0 (absent) to 2 (severe).

Time Frame

Baseline, 12 weeks, 9 months

Title

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 15:Hypochondriasis

Description

Measures hypochondriasis on a scale of 0 (not present) to 4 (hypochondriacal delusions).

Time Frame

Baseline, 12 weeks, 9 months

Title

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 16:Loss of Weight

Description

Measures weight loss since last visit on a scale of 0 (no weight loss) to 2 (definite weight loss caused by present illness).

Time Frame

Baseline, 12 weeks, 9 months

Title

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 17:Insight

Description

Measures insight on a scale of 0 (acknowledges being depressed and ill) to 2 (denies being ill at all).

Time Frame

Baseline, 12 weeks, 9 months

Title

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18A:Diurnal Variation

Description

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).

Time Frame

Baseline, 12 weeks, 9 months

Title

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18B:Diurnal Variation-Severity

Description

Measures the severity of the diurnal variation on a scale of 0 (none) to 2 (severe).

Time Frame

Baseline, 12 weeks, 9 months

Title

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 19: Depersonalization and Derealization

Description

Measures feelings of unreality on a scale of 0 (absent) to 4 (incapacitating).

Time Frame

Baseline, 12 weeks, 9 months

Title

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 20:Paranoid Symptoms

Description

Measures paranoid symptoms on a scale of 0 (none) to 2 (severe).

Time Frame

Baseline, 12 weeks, 9 months

Title

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 21:Obsessional and Compulsive Symptoms

Description

Measures obsessional and compulsive symptoms on a scale of 0 (absent) to 2 (severe).

Time Frame

Baseline, 12 weeks, 9 months

Title

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 22B:Helplessness

Description

Measures feelings of helplessness on a scale of 0 (absent) to 4 (severe).

Time Frame

Baseline, 12 weeks, 9 months

Title

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 23B:Hopelessness

Description

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).

Time Frame

Baseline, 12 weeks, 9 months

Title

Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 24B:Worthlessness

Description

Measures feelings of worthlessness on a scale of 0 (absent) to 4 (severe).

Time Frame

Baseline, 12 weeks, 9 months

Title

Description

Time Frame

Baseline, 12 weeks

Title

Description

Time Frame

Baseline, 9 months

Title

Change From Baseline to 12 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores

Description

Time Frame

Baseline, 12 weeks

Title

Change From Baseline to 9 Month Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores

Description

Time Frame

Baseline, 9 months

Title

Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7

Description

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.

Time Frame

Over 12 weeks

Title

Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 - Percent of Total Effect

Description

For Group A, at least one effect was in the opposite direction, percent of total effect was not calculated.

Time Frame

over 12 weeks

Title

Path Analysis of BPOMS Total Score to Overall Improvement in Sheehan Disability Scale (SDS) Total Score

Description

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.

Time Frame

over 12 weeks

Title

Path Analysis of BPOMS Total Score to Overall Improvement in SDS Total Score - Percent of Total Effect

Description

For Group A, at least one effect was in the opposite direction, percent of total effect was not calculated.

Time Frame

Over 12 weeks

Title

Change From Baseline to 12 Week and 9 Month Endpoints in 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) Total Score

Description

A 16-item patient-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity.

Time Frame

Baseline, 12 weeks, 9 months

Title

Probability of Remission at 12 Week Endpoint and Sustained Remission at 9 Month Endpoint

Description

Time Frame

12 weeks, 9 months

Title

Probability of Response at 12 Week Endpoint

Description

Time Frame

12 weeks

Title

Change From Baseline to 12 Week and 9 Month Endpoints in Pain Numerical Rating Scale (NRS)

Description

Time Frame

Baseline, 12 weeks, 9 months

Title

Change From Baseline to 12 Week and 9 Month Endpoint in the Clinical Global Impression-Severity Scale (CGI-S)

Description

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.

Time Frame

Baseline, 12 weeks, 9 months

Title

Change From Baseline to 12 Week and 9 Month Endpoints in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ)

Description

Time Frame

Baseline, 12 weeks, 9 months

Title

Change From Baseline to 12 Week and 9 Month Endpoints in the Social Adaptation Self-evaluation Scale (SASS) Total Score

Description

Time Frame

Baseline, 12 weeks, 9 months

Title

Change From Baseline to 12 Week and 9 Month Endpoints in Blood Pressure

Description

Sitting systolic and diastolic blood pressure.

Time Frame

Baseline, 12 weeks, 9 months

Title

Change From Baseline to 12 Week and 9 Month Endpoints in Pulse Rate

Time Frame

Baseline, 12 weeks, 9 months

Title

Change From Baseline to 12 Week and 9 Month Endpoints in Weight

Time Frame

Baseline, 12 weeks, 9 months

Title

Abnormal Vital Signs at Anytime Over 12 Weeks

Time Frame

over 12 weeks

Title

Abnormal Vital Signs at Anytime Over 9 Months

Time Frame

over 9 months

Title

Abnormal Vital Signs at 12 Week Endpoint

Time Frame

12 weeks

Title

Abnormal Vital Signs at 9 Month Endpoint

Time Frame

9 months

Title

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

Title

Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Hematocrit

Time Frame

Baseline, 12 weeks, 9 months

Title

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

Title

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

Title

Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Platelet Count

Time Frame

Baseline, 12 weeks, 9 months

Title

Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Alkaline Phosphatase

Time Frame

baseline, 9 months

Title

Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Hemoglobin

Time Frame

Baseline, 9 months

Title

Statistically Significant Abnormal Laboratory Values at Anytime/12 Week Endpoint

Description

The number of participants with statistically significant abnormal lab values at anytime and at 12 week endpoint were the same.

Time Frame

over 3 months

Title

Statistically Significant Abnormal Laboratory Values at Anytime During 9 Months

Time Frame

over 9 months

Title

Statistically Significant Abnormal Laboratory Values at 9 Month Endpoint

Time Frame

9 months

Title

Summary of Adverse Events Leading to Discontinuation

Time Frame

over 9 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90210

Country

United States

Facility Name

City

Escondido

State/Province

California

ZIP/Postal Code

92025

Country

United States

Facility Name

City

National City

State/Province

California

ZIP/Postal Code

91950

Country

United States

Facility Name

City

Hamden

State/Province

Connecticut

ZIP/Postal Code

06518

Country

United States

Facility Name

City

New Britain

State/Province

Connecticut

ZIP/Postal Code

06050

Country

United States

Facility Name

City

New London

State/Province

Connecticut

ZIP/Postal Code

06320

Country

United States

Facility Name

City

Wilmington

State/Province

Delaware

ZIP/Postal Code

19808

Country

United States

Facility Name

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20037

Country

United States

Facility Name

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34208

Country

United States

Facility Name

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33912

Country

United States

Facility Name

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32606

Country

United States

Facility Name

City

Maitland

State/Province

Florida

ZIP/Postal Code

32751

Country

United States

Facility Name

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30328

Country

United States

Facility Name

City

Edwardsville

State/Province

Illinois

ZIP/Postal Code

62025

Country

United States

Facility Name

City

Hoffman Estates

State/Province

Illinois

ZIP/Postal Code

60169

Country

United States

Facility Name

City

Naperville

State/Province

Illinois

ZIP/Postal Code

60540

Country

United States

Facility Name

City

Oak Brook

State/Province

Illinois

ZIP/Postal Code

60523

Country

United States

Facility Name

City

Lafayette

State/Province

Indiana

ZIP/Postal Code

47905

Country

United States

Facility Name

City

Terre Haute

State/Province

Indiana

ZIP/Postal Code

47802

Country

United States

Facility Name

City

Prairie Village

State/Province

Kansas

ZIP/Postal Code

66206

Country

United States

Facility Name

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21285

Country

United States

Facility Name

City

Glen Burnie

State/Province

Maryland

ZIP/Postal Code

21061

Country

United States

Facility Name

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20852

Country

United States

Facility Name

City

Belmont

State/Province

Massachusetts

ZIP/Postal Code

02478

Country

United States

Facility Name

City

Pittsfield

State/Province

Massachusetts

ZIP/Postal Code

01201

Country

United States

Facility Name

City

Chesterfield

State/Province

Missouri

ZIP/Postal Code

63017

Country

United States

Facility Name

City

St Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

City

St. Peters

State/Province

Missouri

ZIP/Postal Code

63376

Country

United States

Facility Name

City

Clementon

State/Province

New Jersey

ZIP/Postal Code

08021

Country

United States

Facility Name

City

Cedarhurst

State/Province

New York

ZIP/Postal Code

11516

Country

United States

Facility Name

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

City

Olean

State/Province

New York

ZIP/Postal Code

14760

Country

United States

Facility Name

City

Staten Island

State/Province

New York

ZIP/Postal Code

10305

Country

United States

Facility Name

City

Allentown

State/Province

Pennsylvania

ZIP/Postal Code

18104

Country

United States

Facility Name

City

Media

State/Province

Pennsylvania

ZIP/Postal Code

19063

Country

United States

Facility Name

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Facility Name

City

Lake Jackson

State/Province

Texas

ZIP/Postal Code

77566

Country

United States

Facility Name

City

Arlington

State/Province

Virginia

ZIP/Postal Code

22201

Country

United States

Facility Name

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22903

Country

United States

Facility Name

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23230

Country

United States

Facility Name

City

Brown Deer

State/Province

Wisconsin

ZIP/Postal Code

53223

Country

United States

Facility Name

City

West Allis

State/Province

Wisconsin

ZIP/Postal Code

53227

Country

United States

Facility Name

City

Arecibo

ZIP/Postal Code

00612

Country

Puerto Rico

Facility Name

City

Caguas

ZIP/Postal Code

00725

Country

Puerto Rico

Facility Name

City

Ponce

ZIP/Postal Code

00731

Country

Puerto Rico

Facility Name

City

San Juan

ZIP/Postal Code

00907

Country

Puerto Rico

12. IPD Sharing Statement

Citations:

PubMed Identifier

25980552

Citation

Harada E, Kato M, Fujikoshi S, Wohlreich MM, Berggren L, Tokuoka H. Changes in energy during treatment of depression: an analysis of duloxetine in double-blind placebo-controlled trials. Int J Clin Pract. 2015 Oct;69(10):1139-48. doi: 10.1111/ijcp.12658. Epub 2015 May 16.

Results Reference

derived

PubMed Identifier

25080392

Citation

Dodd S, Berk M, Kelin K, Zhang Q, Eriksson E, Deberdt W, Craig Nelson J. Application of the Gradient Boosted method in randomised clinical trials: Participant variables that contribute to depression treatment efficacy of duloxetine, SSRIs or placebo. J Affect Disord. 2014 Oct;168:284-93. doi: 10.1016/j.jad.2014.05.014. Epub 2014 Jun 4.

Results Reference

derived

Learn more about this trial

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

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