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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00536471
First received: September 25, 2007
Last updated: November 17, 2009
Last verified: November 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Total Score [ Time Frame: Baseline, 12 weeks, 9 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 3:Suicide [ Time Frame: Baseline, 12 weeks, 9 Months ] [ Designated as safety issue: No ]
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 4:Insomnia Early [ Time Frame: Baseline, 12 weeks, 9 months ] [ Designated as safety issue: No ]
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 5:Insomnia Middle [ Time Frame: Baseline, 12 weeks, 9 months ] [ Designated as safety issue: No ]
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 6:Insomnia Late [ Time Frame: Baseline, 12 weeks, 9 months ] [ Designated as safety issue: No ]
  • Change From Baseline to 9 Month Endpoint in HAMD-24 - Item 7:Work and Activities [ Time Frame: Baseline, 9 months ] [ Designated as safety issue: No ]
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 8:Retardation [ Time Frame: Baseline, 12 weeks, 9 months ] [ Designated as safety issue: No ]
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 9:Agitation [ Time Frame: Baseline, 12 weeks, 9 months ] [ Designated as safety issue: No ]
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 10:Anxiety (Psychic) [ Time Frame: Baseline, 12 weeks, 9 months ] [ Designated as safety issue: No ]
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 11:Anxiety (Somatic) [ Time Frame: Baseline, 12 weeks, 9 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 14:Genital Symptoms [ Time Frame: Baseline, 12 weeks, 9 months ] [ Designated as safety issue: No ]
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 15:Hypochondriasis [ Time Frame: Baseline, 12 weeks, 9 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 17:Insight [ Time Frame: Baseline, 12 weeks, 9 months ] [ Designated as safety issue: No ]
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18A:Diurnal Variation [ Time Frame: Baseline, 12 weeks, 9 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 20:Paranoid Symptoms [ Time Frame: Baseline, 12 weeks, 9 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 22B:Helplessness [ Time Frame: Baseline, 12 weeks, 9 months ] [ Designated as safety issue: No ]
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 23B:Hopelessness [ Time Frame: Baseline, 12 weeks, 9 months ] [ Designated as safety issue: No ]
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 24B:Worthlessness [ Time Frame: Baseline, 12 weeks, 9 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change From Baseline to 12 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to 9 Month Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores [ Time Frame: Baseline, 9 months ] [ Designated as safety issue: No ]
  • Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 [ Time Frame: Over 12 weeks ] [ Designated as safety issue: No ]
  • Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 - Percent of Total Effect [ Time Frame: over 12 weeks ] [ Designated as safety issue: No ]
  • Path Analysis of BPOMS Total Score to Overall Improvement in Sheehan Disability Scale (SDS) Total Score [ Time Frame: over 12 weeks ] [ Designated as safety issue: No ]
  • Path Analysis of BPOMS Total Score to Overall Improvement in SDS Total Score - Percent of Total Effect [ Time Frame: Over 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Probability of Remission at 12 Week Endpoint and Sustained Remission at 9 Month Endpoint [ Time Frame: 12 weeks, 9 months ] [ Designated as safety issue: No ]
  • Probability of Response at 12 Week Endpoint [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to 12 Week and 9 Month Endpoints in Pain Numerical Rating Scale (NRS) [ Time Frame: Baseline, 12 weeks, 9 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change From Baseline to 12 Week and 9 Month Endpoints in Blood Pressure [ Time Frame: Baseline, 12 weeks, 9 months ] [ Designated as safety issue: Yes ]
  • Change From Baseline to 12 Week and 9 Month Endpoints in Pulse Rate [ Time Frame: Baseline, 12 weeks, 9 months ] [ Designated as safety issue: Yes ]
  • Change From Baseline to 12 Week and 9 Month Endpoints in Weight [ Time Frame: Baseline, 12 weeks, 9 months ] [ Designated as safety issue: Yes ]
  • Abnormal Vital Signs at Anytime Over 12 Weeks [ Time Frame: over 12 weeks ] [ Designated as safety issue: Yes ]
  • Abnormal Vital Signs at Anytime Over 9 Months [ Time Frame: over 9 months ] [ Designated as safety issue: Yes ]
  • Abnormal Vital Signs at 12 Week Endpoint [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Abnormal Vital Signs at 9 Month Endpoint [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Hematocrit [ Time Frame: Baseline, 12 weeks, 9 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Platelet Count [ Time Frame: Baseline, 12 weeks, 9 months ] [ Designated as safety issue: Yes ]
  • Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Alkaline Phosphatase [ Time Frame: baseline, 9 months ] [ Designated as safety issue: Yes ]
  • Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Hemoglobin [ Time Frame: Baseline, 9 months ] [ Designated as safety issue: Yes ]
  • Statistically Significant Abnormal Laboratory Values at Anytime/12 Week Endpoint [ Time Frame: over 3 months ] [ Designated as safety issue: Yes ]
  • Statistically Significant Abnormal Laboratory Values at Anytime During 9 Months [ Time Frame: over 9 months ] [ Designated as safety issue: Yes ]
  • Statistically Significant Abnormal Laboratory Values at 9 Month Endpoint [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Summary of Adverse Events Leading to Discontinuation [ Time Frame: over 9 months ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00536471     History of Changes
Other Study ID Numbers: 11669, F1J-US-HMFS
Study First Received: September 25, 2007
Results First Received: May 28, 2009
Last Updated: November 17, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Duloxetine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents

ClinicalTrials.gov processed this record on August 20, 2014