Phase 4
Completed N=776
A Study Comparing Duloxetine and Placebo in Assessing Energy and Vitality in Major Depressive Disorder (MDD) Patients
Source: ClinicalTrials.gov NCT00536471 ↗Enrolled (actual)
776
Serious AEs
—
Results posted
Jul 2009
Primary outcomePrimary: Change From Baseline to 8 Weeks in 24-Item Hamilton Depression Rating Scale (HAMD-24) Item 7 (Work and Activities) — -1.32; -1.07; -1.37; -0.93 units on a scale — p=0.051
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to 8 Weeks in 24-Item Hamilton Depression Rating Scale (HAMD-24) Item 7 (Work and Activities) |
-1.32; -1.07; -1.37; -0.93 | 0.051 |
| SECONDARY 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) |
-12.64; -10.33; -12.11; -8.48; -6.11; -4.69 | 0.013 sig |
| SECONDARY Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Total Score |
-16.24; -13.24; -15.60; -10.94; -17.05; -15.22 | 0.011 sig |
| SECONDARY Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Item 1:Depressed Mood |
-1.86; -1.52; -1.78; -1.15; -1.44; -1.26 | 0.016 sig |
| SECONDARY Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 2:Feelings of Guilt |
-1.19; -1.06; -1.15; -0.89; -1.32; -1.21 | 0.204 |
| SECONDARY Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 3:Suicide |
-0.46; -0.30; -0.40; -0.29; -1.32; -1.21 | 0.023 sig |
| SECONDARY Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 4:Insomnia Early |
-0.72; -0.61; -0.68; -0.46; -0.85; -0.77 | 0.332 |
| SECONDARY Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 5:Insomnia Middle |
-0.69; -0.74; -0.66; -0.59; -0.99; -0.92 | 0.624 |
| SECONDARY Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 6:Insomnia Late |
-0.66; -0.49; -0.57; -0.45; -0.94; -0.87 | 0.099 |
| SECONDARY Change From Baseline to 9 Month Endpoint in HAMD-24 - Item 7:Work and Activities |
-2.43; -2.55; -1.66; -1.50 | 0.577 |
| SECONDARY Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 8:Retardation |
-0.72; -0.69; -0.66; -0.51; -0.89; -0.90 | 0.670 |
| SECONDARY Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 9:Agitation |
-0.47; -0.48; -0.44; -0.41; -0.53; -0.61 | 0.896 |
| SECONDARY Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 10:Anxiety (Psychic) |
-1.15; -0.90; -1.15; -0.81; -1.23; -1.13 | 0.038 sig |
| SECONDARY Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 11:Anxiety (Somatic) |
-0.61; -0.65; -0.68; -0.57; -0.98; -0.94 | 0.723 |
| SECONDARY Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 12:Somatic Symptoms/Gastrointestinal |
-0.44; -0.52; -0.40; -0.32; -0.98; -0.94 | 0.234 |
| SECONDARY Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 13:Somatic Symptoms/General |
-0.91; -0.88; -0.75; -0.49; -1.36; -1.18 | 0.789 |
| SECONDARY Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 14:Genital Symptoms |
-0.57; -0.54; -0.55; -0.40; -0.89; -0.77 | 0.780 |
| SECONDARY Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 15:Hypochondriasis |
-0.36; -0.41; -0.52; -0.41; -0.44; -0.53 | 0.517 |
| SECONDARY Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 16:Loss of Weight |
-0.21; -0.20; -0.25; -0.24; -0.44; -0.53 | 0.741 |
| SECONDARY Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 17:Insight |
-0.08; -0.07; -0.01; -0.01; -0.44; -0.53 | 0.723 |
| SECONDARY Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18A:Diurnal Variation |
-0.32; -0.36; -0.45; -0.13; -0.56; -0.26 | 0.682 |
| SECONDARY Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18B:Diurnal Variation-Severity |
-0.43; -0.49; -0.42; -0.21; -0.60; -0.54 | 0.438 |
| SECONDARY Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 19: Depersonalization and Derealization |
-0.19; -0.21; -0.15; -0.14; -0.60; -0.54 | 0.588 |
| SECONDARY Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 20:Paranoid Symptoms |
-0.15; -0.12; -0.13; -0.11; -0.60; -0.54 | 0.507 |
| SECONDARY Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 21:Obsessional and Compulsive Symptoms |
-0.08; -0.06; -0.04; -0.06; -0.60; -0.54 | 0.487 |
| SECONDARY Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 22B:Helplessness |
-0.95; -0.88; -0.98; -0.81; -1.16; -0.90 | 0.505 |
| SECONDARY Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 23B:Hopelessness |
-0.87; -0.74; -0.80; -0.51; -1.23; -1.34 | 0.175 |
| SECONDARY Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 24B:Worthlessness |
-1.00; -0.95; -0.95; -0.79; -1.23; -1.34 | 0.675 |
| SECONDARY 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). |
-26.41; -18.88; -28.67; -22.67; -4.37; -3.20 | 0.007 sig |
| SECONDARY 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) |
-25.67; -22.99; -28.39; -25.51; -5.36; -4.18 | 0.639 |
| SECONDARY Change From Baseline to 12 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores |
-2.47; -2.12; -1.98; -1.22; -2.93; -2.50 | 0.366 |
| SECONDARY Change From Baseline to 9 Month Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores |
-3.88; -4.01; -2.26; -2.16; -4.15; -4.35 | 0.921 |
| SECONDARY Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 |
-0.032; -0.012; 0.219; 0.087; 0.376; 0.145 | 0.753 |
| SECONDARY Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 - Percent of Total Effect |
51.14; 48.86; 100.00 | — |
| SECONDARY Path Analysis of BPOMS Total Score to Overall Improvement in Sheehan Disability Scale (SDS) Total Score |
-0.577; -0.032; 0.955; 0.052; 2.754; 0.151 | 0.342 |
| SECONDARY Path Analysis of BPOMS Total Score to Overall Improvement in SDS Total Score - Percent of Total Effect |
35.17; 64.83; 100.00 | — |
| SECONDARY Change From Baseline to 12 Week and 9 Month Endpoints in 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) Total Score |
-6.31; -5.65; -6.54; -5.21; -8.41; -6.85 | 0.302 |
| SECONDARY Probability of Remission at 12 Week Endpoint and Sustained Remission at 9 Month Endpoint |
0.38; 0.35; 0.35; 0.18; 0.30; 0.30 | 0.731 |
| SECONDARY Probability of Response at 12 Week Endpoint |
0.63; 0.60; 0.63; 0.46; 0.44; 0.41 | 0.653 |
| SECONDARY Change From Baseline to 12 Week and 9 Month Endpoints in Pain Numerical Rating Scale (NRS) |
-1.14; -1.35; -0.96; -1.16; -1.33; -1.73 | 0.475 |
| SECONDARY Change From Baseline to 12 Week and 9 Month Endpoint in the Clinical Global Impression-Severity Scale (CGI-S) |
-1.93; -1.58; -1.97; -1.25; -2.14; -1.97 | 0.032 sig |
| SECONDARY Change From Baseline to 12 Week and 9 Month Endpoints in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) |
-7.60; -6.39; -7.96; -6.85; -7.17; -7.13 | 0.161 |
| SECONDARY Change From Baseline to 12 Week and 9 Month Endpoints in the Social Adaptation Self-evaluation Scale (SASS) Total Score |
7.18; 3.40; 7.54; 4.52; 8.00; 5.30 | 0.001 sig |
| SECONDARY Change From Baseline to 12 Week and 9 Month Endpoints in Blood Pressure |
-0.12; 0.05; 0.73; -2.95; 0.48; -0.58 | 0.914 |
| SECONDARY Change From Baseline to 12 Week and 9 Month Endpoints in Pulse Rate |
1.40; -1.52; 0.68; -2.05; 1.08; -0.30 | 0.012 sig |
| SECONDARY Change From Baseline to 12 Week and 9 Month Endpoints in Weight |
-0.54; 0.38; -0.38; -0.23; -1.18; -0.44 | 0.013 sig |
| SECONDARY Abnormal Vital Signs at Anytime Over 12 Weeks |
1; 0; 1; 0; 0; 0 | — |
| SECONDARY Abnormal Vital Signs at Anytime Over 9 Months |
1; 0; 2; 0; 2; 0 | — |
| SECONDARY Abnormal Vital Signs at 12 Week Endpoint |
0; 0; 1; 0; 0; 0 | — |
| SECONDARY Abnormal Vital Signs at 9 Month Endpoint |
0; 0; 1; 0; 2; 0 | — |
| SECONDARY Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Bilirubin, Creatinine, Uric Acid |
0.10; -0.19; -0.51; 0.13; -1.56; -0.85 | 0.046 sig |
| SECONDARY Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Hematocrit |
-0.00; -0.01; 0.00; -0.01; -0.00; -0.00 | 0.037 sig |
| SECONDARY Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Mean Cell Volume (MCV) |
0.98; 1.30; 0.71; -0.47; 1.07; 1.66 | 0.013 sig |
| SECONDARY Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Chloride, Urea Nitrogen, Cholesterol, Sodium |
-0.80; 0.24; -0.91; -0.39; -0.06; 0.26 | 0.022 sig |
| SECONDARY Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Platelet Count |
8.11; -7.10; 10.55; 12.02; 8.06; -10.17 | 0.017 sig |
| SECONDARY Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Alkaline Phosphatase |
-0.18; -2.30; 0.23; -3.75 | 0.033 sig |
| SECONDARY Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Hemoglobin |
-0.13; -0.19; -0.01; -0.17 | 0.045 sig |
| SECONDARY Statistically Significant Abnormal Laboratory Values at Anytime/12 Week Endpoint |
1; 3; 2; 1; 0; 0 | 0.041 sig |
| SECONDARY Statistically Significant Abnormal Laboratory Values at Anytime During 9 Months |
1; 4; 2; 1; 0; 0 | 0.012 sig |
| SECONDARY Statistically Significant Abnormal Laboratory Values at 9 Month Endpoint |
1; 4; 1; 1; 5; 2 | 0.012 sig |
| SECONDARY Summary of Adverse Events Leading to Discontinuation |
5; 0; 0; 1; 2; 1 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00536471). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.