A Study Comparing Duloxetine and Placebo in Assessing Energy and Vitality in MDD Patients - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00536471

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 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 IV

MedlinePlus related topics: Depression

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Duloxetine Versus Placebo in Patients With Major Depressive Disorder (MDD): Assessment of Energy and Vitality in MDD

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Change from baseline in Hamilton Depression Rating Scale (HAMD 24) Item 7 (Work and Activities) [ Time Frame: over 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in the HAMD17 Total Score and HAMD24 Total Score, and all subscales and all individual items [ Time Frame: over 3 months ] [ Designated as safety issue: No ]
Change from baseline 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: over 3 months ] [ Designated as safety issue: No ]
Change from baseline in Sheehan Disability Scale (SDS) total score and subscores [ Time Frame: over 3 months ] [ Designated as safety issue: No ]
Relative contribution of improvement on the mood states, defined by BPOMS subscales to overall improvement in work and activities, HAMD24 item 7 using path analysis [ Time Frame: over 3 months ] [ Designated as safety issue: No ]
Relative contribution of improvement on the mood states, defined by BPOMS subscales to overall improvement in SDS total score using path analysis [ Time Frame: over 3 months ] [ Designated as safety issue: No ]
Change from baseline in 16-item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) Total Score [ Time Frame: over 3 months ] [ Designated as safety issue: No ]
Probability of Remission as measured by the HAMD17 Total Score ≤ 7 and by the QIDS16SR Total Score ≤ 5 [ Time Frame: over 3 months ] [ Designated as safety issue: No ]
Response Rates at endpoint as measured by ≥ 50% improvement in the HAMD17 Total Score and ≥ 50% improvement in the QIDS16SR Total Score [ Time Frame: over 3 months ] [ Designated as safety issue: No ]
Change from baseline in Pain Numerical Rating Scale (NRS) [ Time Frame: over 3 months ] [ Designated as safety issue: No ]
Change from baseline in the Clinical Global Impression-Severity Scale (CGI-S) [ Time Frame: over 3 months ] [ Designated as safety issue: No ]
Change from baseline in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) [ Time Frame: over 3 months ] [ Designated as safety issue: No ]
Change from baseline on the patient reported quality of life outcomes as measured by the Social Adaptation Self-evaluation Scale (SASS) [ Time Frame: over 3 months ] [ Designated as safety issue: No ]
Change in vital signs and weight, including baseline to endpoint; abnormal values at any time; and abnormal values at endpoint [ Time Frame: over 3 months ] [ Designated as safety issue: Yes ]
Change laboratory values, including baseline to endpoint; abnormal values at any time; and abnormal laboratory values at endpoint [ Time Frame: over 3 months ] [ Designated as safety issue: Yes ]
Summary of Serious Adverse Events and Treatment-emergent adverse events [ Time Frame: over 3 months ] [ Designated as safety issue: Yes ]
Summary of Adverse Events and Serious Adverse Events leading to discontinuation [ Time Frame: over 3 months ] [ Designated as safety issue: Yes ]
Summary of Overall discontinuation rates [ Time Frame: over 3 months ] [ Designated as safety issue: Yes ]
Sustained Remission as measured by the HAMD17 Total Score ≤ 7 and by the QIDS16SR Total Score ≤ 5 in Acute treatment responders (patients who remain on the treatment dose to which they were originally randomized) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Sustained Response at endpoint as measured by ≥ 50% improvement in the HAMD17 Total Score and ≥ 50% improvement in the QIDS16SR Total Score in Acute treatment responders (patients who remain on the treatment dose to which they were originally randomized) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Change from baseline in Hamilton Depression Rating Scale (HAMD 24) Item 7 (Work and Activities)in Acute treatment responders (patients who remain on the treatment dose to which they were originally randomized) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Change from baseline in the HAMD17 Total Score and HAMD24 Total Score, and all subscales and all individual items in Acute treatment responders (patients who remain on the treatment dose to which they were originally randomized) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Change from baseline in 30-item Brief Profile of Mood States (BPOMS) Scale and subscales in Acute treatment responders (patients who remain on the treatment dose to which they were originally randomized) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Change from baseline in Sheehan Disability Scale (SDS) total score and subscores in Acute treatment responders (patients who remain on the treatment dose to which they were originally randomized) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Relative contribution of improvement on the mood states, defined by BPOMS subscales to overall improvement in work and activities, HAMD24 item 7 using path analysis in Acute treatment responders [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Relative contribution of improvement on the mood states, defined by BPOMS subscales to overall improvement in SDS total score using path analysis in Acute treatment responders [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Change from baseline in 16-item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) Total Score in Acute treatment responders (patients who remain on the treatment dose to which they were originally randomized) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Change from baseline in Pain Numerical Rating Scale (NRS) in Acute treatment responders (patients who remain on the treatment dose to which they were originally randomized) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Change from baseline in the Clinical Global Impression-Severity Scale (CGI-S) in Acute treatment responders (patients who remain on the treatment dose to which they were originally randomized) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Change from baseline in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) in Acute treatment responders (patients who remain on the treatment dose to which they were originally randomized) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Change from baseline on the patient reported quality of life outcomes as measured by the Social Adaptation Self-evaluation Scale (SASS) in Acute treatment responders (patients who remain on the treatment dose to which they were originally randomized) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Change in vital signs and weight, including baseline to endpoint; abnormal values at any time; and abnormal values at endpoint in Acute treatment responders (patients who remain on the treatment dose to which they were originally randomized) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
Change laboratory values, including baseline to endpoint; abnormal values at any time; and abnormal laboratory values at endpoint in Acute treatment responders (patients who remain on the treatment dose to which they were originally randomized) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
Summary of Serious Adverse Events and Treatment-emergent adverse events in Acute treatment responders (patients who remain on the treatment dose to which they were originally randomized) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
Summary of Adverse Events and Serious Adverse Events leading to discontinuation in Acute treatment responders (patients who remain on the treatment dose to which they were originally randomized) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
Summary of Overall discontinuation rates in Acute treatment responders (patients who remain on the treatment dose to which they were originally randomized) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
To assess predictors of remission based on early drug vs. placebo response in various MDD symptom domains as defined by total scores, subscale scores, and individual item scores from the efficacy and quality of life measures [ Time Frame: over 3, 9 months ] [ Designated as safety issue: No ]
To investigate differential patterns of symptom response between duloxetine acute treatment responders (60 mg/day) and nonresponders (dose increase to 120 mg/day) using patient-rated efficacy and quality of life assessments [ Time Frame: over 9 months ] [ Designated as safety issue: No ]

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

Arms	Assigned Interventions
A: Experimental duloxetine 60 mg QD, PO for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months	Drug: Duloxetine hydrochloride
B: Placebo Comparator placebo QD, PO for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months	Drug: Placebo

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	11669, F1J-US-HMFS
Study First Received:	September 25, 2007
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00536471 History of Changes
Health Authority:	United States: Food and Drug Administration