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

• ClinicalTrials.gov Identifier: NCT00536471
• Recruitment Status: Completed
• First Posted: September 27, 2007
• Results First Posted: July 17, 2009
• Last Update Posted: November 20, 2009
• Sponsor: Eli Lilly and Company
• Information provided by: Eli Lilly and Company

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.

Condition or disease	Intervention/treatment	Phase
Major Depressive Disorder	Drug: Duloxetine hydrochloride; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 776 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Duloxetine Versus Placebo in Patients With Major Depressive Disorder (MDD): Assessment of Energy and Vitality in MDD
• Study Start Date: September 2007
• Actual Primary Completion Date: May 2008
• Actual Study Completion Date: December 2008

Arms and Interventions

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: LY248686; Cymbalta
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

Outcome Measures

Primary Outcome Measures :

1. 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).

Secondary Outcome Measures :

1. 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.
2. Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Total Score [ Time Frame: Baseline, 12 weeks, 9 months ]
3. 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).
4. 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).
5. 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).
6. 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).
7. 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).
8. 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).
9. 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).
10. 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).
11. 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)
12. 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)
13. 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).
14. 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).
15. 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).
16. 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).
17. 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).
18. 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).
19. 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).
20. 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).
21. 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).
22. 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).
23. 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).
24. 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).
25. 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).
26. 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).
27. 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).
28. 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).
29. 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).
30. 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.
31. 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.
32. 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.
33. 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.
34. 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.
35. 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.
36. 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.
37. 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.
38. 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.
39. 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).
40. 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.
41. 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.
42. 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.
43. 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.
44. Change From Baseline to 12 Week and 9 Month Endpoints in Pulse Rate [ Time Frame: Baseline, 12 weeks, 9 months ]
45. Change From Baseline to 12 Week and 9 Month Endpoints in Weight [ Time Frame: Baseline, 12 weeks, 9 months ]
46. Abnormal Vital Signs at Anytime Over 12 Weeks [ Time Frame: over 12 weeks ]
47. Abnormal Vital Signs at Anytime Over 9 Months [ Time Frame: over 9 months ]
48. Abnormal Vital Signs at 12 Week Endpoint [ Time Frame: 12 weeks ]
49. Abnormal Vital Signs at 9 Month Endpoint [ Time Frame: 9 months ]
50. 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 ]
51. Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Hematocrit [ Time Frame: Baseline, 12 weeks, 9 months ]
52. 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 ]
53. 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 ]
54. Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Platelet Count [ Time Frame: Baseline, 12 weeks, 9 months ]
55. Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Alkaline Phosphatase [ Time Frame: baseline, 9 months ]
56. Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Hemoglobin [ Time Frame: Baseline, 9 months ]
57. 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.
58. Statistically Significant Abnormal Laboratory Values at Anytime During 9 Months [ Time Frame: over 9 months ]
59. Statistically Significant Abnormal Laboratory Values at 9 Month Endpoint [ Time Frame: 9 months ]
60. Summary of Adverse Events Leading to Discontinuation [ Time Frame: over 9 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, California

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Beverly Hills, California, United States, 90210

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Escondido, California, United States, 92025

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National City, California, United States, 91950

United States, Connecticut

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Hamden, Connecticut, United States, 06518

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New Britain, Connecticut, United States, 06050

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New London, Connecticut, United States, 06320

United States, Delaware

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Wilmington, Delaware, United States, 19808

United States, District of Columbia

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Washington, District of Columbia, United States, 20037

United States, Florida

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Bradenton, Florida, United States, 34208

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Fort Myers, Florida, United States, 33912

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Gainesville, Florida, United States, 32606

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Maitland, Florida, United States, 32751

United States, Georgia

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Atlanta, Georgia, United States, 30328

United States, Illinois

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Edwardsville, Illinois, United States, 62025

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Hoffman Estates, Illinois, United States, 60169

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Naperville, Illinois, United States, 60540

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Oak Brook, Illinois, United States, 60523

United States, Indiana

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Lafayette, Indiana, United States, 47905

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Terre Haute, Indiana, United States, 47802

United States, Kansas

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Prairie Village, Kansas, United States, 66206

United States, Maryland

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Baltimore, Maryland, United States, 21285

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Glen Burnie, Maryland, United States, 21061

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Rockville, Maryland, United States, 20852

United States, Massachusetts

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Belmont, Massachusetts, United States, 02478

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Pittsfield, Massachusetts, United States, 01201

United States, Missouri

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Chesterfield, Missouri, United States, 63017

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St Louis, Missouri, United States, 63141

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St. Peters, Missouri, United States, 63376

United States, New Jersey

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Clementon, New Jersey, United States, 08021

United States, New York

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Cedarhurst, New York, United States, 11516

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New York, New York, United States, 10021

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Olean, New York, United States, 14760

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Staten Island, New York, United States, 10305

United States, Pennsylvania

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Allentown, Pennsylvania, United States, 18104

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Media, Pennsylvania, United States, 19063

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Philadelphia, Pennsylvania, United States, 19104

United States, Tennessee

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Memphis, Tennessee, United States, 38119

United States, Texas

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Lake Jackson, Texas, United States, 77566

United States, Virginia

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Arlington, Virginia, United States, 22201

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Charlottesville, Virginia, United States, 22903

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Richmond, Virginia, United States, 23230

United States, Wisconsin

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Brown Deer, Wisconsin, United States, 53223

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West Allis, Wisconsin, United States, 53227

Puerto Rico

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Arecibo, Puerto Rico, 00612

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Caguas, Puerto Rico, 00725

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Ponce, Puerto Rico, 00731

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San Juan, Puerto Rico, 00907

Sponsors and Collaborators

Eli Lilly and Company

Investigators

• Study Director: 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); Eli Lilly and Company

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Chief Medical Officer, Eli Lilly
• ClinicalTrials.gov Identifier: NCT00536471
• Other Study ID Numbers: 11669; F1J-US-HMFS
• First Posted: September 27, 2007
• Results First Posted: July 17, 2009
• Last Update Posted: November 20, 2009
• Last Verified: November 2009

Additional relevant MeSH terms:

Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders; Behavioral Symptoms; Duloxetine Hydrochloride; Serotonin and Noradrenaline Reuptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Antidepressive Agents; Psychotropic Drugs; Dopamine Agents