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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00536471
First Posted: September 27, 2007
Last Update Posted: November 20, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Eli Lilly and Company
  Purpose
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 Intervention Phase
Major Depressive Disorder Drug: Duloxetine hydrochloride Drug: Placebo Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ]

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) [ Time Frame: 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 ]
  • 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 ]
  • 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 ]
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 3:Suicide [ Time Frame: 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 ]
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 5:Insomnia Middle [ Time Frame: 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 ]
  • Change From Baseline to 9 Month Endpoint in HAMD-24 - Item 7:Work and Activities [ Time Frame: 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 ]
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 9:Agitation [ Time Frame: 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 ]
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 11:Anxiety (Somatic) [ Time Frame: 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 ]
  • 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 ]
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 14:Genital Symptoms [ Time Frame: 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 ]
  • 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 ]
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 17:Insight [ Time Frame: 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 ]
  • 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 ]
  • 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 ]
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 20:Paranoid Symptoms [ Time Frame: 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 ]
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 22B:Helplessness [ Time Frame: 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 ]
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 24B:Worthlessness [ Time Frame: 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 ]
  • 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 ]
  • Change From Baseline to 12 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores [ Time Frame: Baseline, 12 weeks ]
  • Change From Baseline to 9 Month Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores [ Time Frame: Baseline, 9 months ]
  • Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 [ Time Frame: 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 ]
  • Path Analysis of BPOMS Total Score to Overall Improvement in Sheehan Disability Scale (SDS) Total Score [ Time Frame: 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 ]
  • 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 ]
  • Probability of Remission at 12 Week Endpoint and Sustained Remission at 9 Month Endpoint [ Time Frame: 12 weeks, 9 months ]
  • Probability of Response at 12 Week Endpoint [ Time Frame: 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Change From Baseline to 12 Week and 9 Month Endpoints in Blood Pressure [ Time Frame: 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 ]
  • Change From Baseline to 12 Week and 9 Month Endpoints in Weight [ Time Frame: Baseline, 12 weeks, 9 months ]
  • Abnormal Vital Signs at Anytime Over 12 Weeks [ Time Frame: over 12 weeks ]
  • Abnormal Vital Signs at Anytime Over 9 Months [ Time Frame: over 9 months ]
  • Abnormal Vital Signs at 12 Week Endpoint [ Time Frame: 12 weeks ]
  • Abnormal Vital Signs at 9 Month Endpoint [ Time Frame: 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 ]
  • Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Hematocrit [ Time Frame: 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 ]
  • 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 ]
  • Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Platelet Count [ Time Frame: Baseline, 12 weeks, 9 months ]
  • Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Alkaline Phosphatase [ Time Frame: baseline, 9 months ]
  • Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Hemoglobin [ Time Frame: Baseline, 9 months ]
  • Statistically Significant Abnormal Laboratory Values at Anytime/12 Week Endpoint [ Time Frame: over 3 months ]
  • Statistically Significant Abnormal Laboratory Values at Anytime During 9 Months [ Time Frame: over 9 months ]
  • Statistically Significant Abnormal Laboratory Values at 9 Month Endpoint [ Time Frame: 9 months ]
  • Summary of Adverse Events Leading to Discontinuation [ Time Frame: over 9 months ]

Enrollment: 776
Study Start Date: September 2007
Study Completion Date: December 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00536471


  Show 47 Study Locations
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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00536471     History of Changes
Other Study ID Numbers: 11669
F1J-US-HMFS
First Submitted: September 25, 2007
First Posted: September 27, 2007
Results First Submitted: May 28, 2009
Results First Posted: July 17, 2009
Last Update Posted: November 20, 2009
Last Verified: November 2009

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
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