Phase 3
N=514
Duloxetine Versus Placebo in the Prevention of Recurrence of Major Depressive Disorder
Depressive Disorder, Major
Bottom Line
View on ClinicalTrials.gov: NCT00105989 ↗Enrolled (actual)
514
Serious AEs
—
Results posted
Jul 2009
Primary outcome: Primary: Percentage of Participants With Depressive Recurrence After Time (t) in Days — 0.68; 2.11; 1.37; 2.11 percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Duloxetine (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Depressive Recurrence After Time (t) in Days |
0.68; 2.11; 1.37; 2.11; 1.37; 2.82 | <0.001 sig |
| SECONDARY Recurrence Count |
21; 47 | <0.001 sig |
| SECONDARY Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days |
2.07; 1.41; 3.45; 1.41; 5.53; 7.12 | 0.003 sig |
| SECONDARY Loss of Response at Any Time |
44; 66 | 0.003 sig |
| SECONDARY Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Acute and Continuation Phases |
23.07; 6.64; -14.37; -0.61 | <0.001 sig |
| SECONDARY Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Maintenance Phase |
1.40; 4.36 | <0.001 sig |
| SECONDARY Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Acute and Continuation Phases |
4.49; 1.83; -2.30; -0.07 | <0.001 sig |
| SECONDARY Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Maintenance Phase |
0.24; 0.84 | <0.001 sig |
| SECONDARY Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Acute and Continuation Phases |
2.12; 1.76 | <0.001 sig |
| SECONDARY Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Maintenance Phase |
1.72; 2.34 | <0.001 sig |
| SECONDARY Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases |
7.71; 2.51; -4.52; -0.11; 8.81; 2.00 | <0.001 sig |
| SECONDARY Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Maintenance Phase |
0.46; 1.54; 0.75; 1.74; 0.91; 2.25 | <0.001 sig |
| SECONDARY Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase |
34.36; 17.29; -16.34; 1.16; 29.74; 14.80 | <0.001 sig |
| SECONDARY Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Maintenance Phase |
3.92; 4.57; 4.77; 2.80; 1.77; 3.40 | 0.792 |
| SECONDARY Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Acute and Continuation Phases |
12.64; 6.88; -5.37; -0.35 | <0.001 sig |
| SECONDARY Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Maintenance Phase |
0.79; 0.81 | 0.979 |
| SECONDARY Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases |
19.30; 10.72; -7.88; -2.01; 6.52; 3.64 | <0.001 sig |
| SECONDARY Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Maintenance Phase |
-0.05; 2.06; 0.03; 0.83; 0.02; 0.56 | 0.029 sig |
| SECONDARY Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase |
43.55; 48.05; 3.86; 0.03; 23.93; 39.83 | <0.001 sig |
| SECONDARY Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase |
-0.45; 0.33; -1.11; -5.74; 0.06; -0.07 | 0.415 |
| SECONDARY Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Acute and Continuation Phases |
-0.00; -0.00; 0.03; -0.03; 0.01; -0.00 | 0.838 |
| SECONDARY Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Maintenance Phase |
-0.00; -0.00; -0.01; -0.01; -0.02; -0.01 | 0.462 |
| SECONDARY Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Acute and Continuation Phases |
0.36; 0.36; 0.00; 0.01 | 0.506 |
| SECONDARY Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Maintenance Phase |
-0.00; -0.00 | 0.826 |
| SECONDARY Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Acute and Continuation Phase |
1.77; 2.67; 0.46; -0.52 | 0.105 |
| SECONDARY Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Maintenance Phase |
0.27; -0.75 | 0.037 sig |
| SECONDARY Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males) |
17.57; 17.26; 0.13; -0.67; 7.47; 7.16 | 0.785 |
| SECONDARY Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females) |
21.41; 19.31; -1.31; -0.99; 9.31; 8.42 | <0.001 sig |
| SECONDARY Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males) |
-0.97; -0.77; -0.25; 0.03; -0.17; -0.02 | 0.773 |
| SECONDARY Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females) |
-0.65; -0.47; -0.19; 0.34; -0.08; 0.18 | 0.979 |
| SECONDARY Vital Signs - Change From Baseline to Endpoint in Weight - Acute and Continuation Phases |
74.74; 74.22; -0.69; 0.88 | <0.001 sig |
| SECONDARY Vital Signs - Change From Baseline to Endpoint in Weight - Maintenance Phase |
0.88; 0.39 | 0.314 |
| SECONDARY Vital Signs - Change From Baseline to Endpoint in Pulse - Acute and Continuation Phases |
71.76; 72.79; 1.42; 1.75 | <0.001 sig |
| SECONDARY Vital Signs - Change From Baseline to Endpoint in Pulse - Maintenance Phase |
-1.86; -1.72 | 0.891 |
| SECONDARY Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Acute and Continuation Phases |
125.03; 124.72; 0.25; 0.77; 77.52; 78.28 | 0.659 |
| SECONDARY Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Maintenance Phase |
1.70; -1.11; -0.23; -0.11 | 0.134 |
| SECONDARY Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Acute Phase |
43.05; -0.61 | <.001 sig |
| SECONDARY Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Acute Phase |
2.46; -0.01 | .007 sig |
| SECONDARY Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Chloride - Acute Phase |
103.73; -0.29 | .035 sig |
| SECONDARY Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Eosinophils - Acute Phase |
0.13; 0.01 | .021 sig |
| SECONDARY Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Acute Phase |
29.25; -5.12 | <.001 sig |
| SECONDARY Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Acute Phase |
0.43; -0.00 | .019 sig |
| SECONDARY Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Acute Phase |
8.81; -0.07 | .005 sig |
| SECONDARY Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Platelet Count - Acute Phase |
261.08; 4.23 | .031 sig |
| SECONDARY Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Sodium - Acute Phase |
141.21; -0.64 | <.001 sig |
| SECONDARY Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Acute Phase |
73.59; -1.18 | <.001 sig |
| SECONDARY Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Uric Acid - Acute Phase |
297.05; -10.64 | <.001 sig |
| SECONDARY Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Continuation Phase |
42.43; -0.57 | <.001 sig |
| SECONDARY Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bicarbonate, HCO3 - Continuation Phase |
24.41; 1.04 | <.001 sig |
| SECONDARY Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Direct - Continuation Phase |
2.03; -0.12 | .004 sig |
| SECONDARY Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Total - Continuation Phase |
8.68; -0.50 | .010 sig |
| SECONDARY Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Continuation Phase |
2.45; -0.01 | .003 sig |
| SECONDARY Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Erythrocyte Count - Continuation Phase |
4.74; -0.06 | <.001 sig |
| SECONDARY Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Continuation Phase |
24.13; 2.11 | .015 sig |
| SECONDARY Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Continuation Phase |
0.42; -0.00 | .021 sig |
| SECONDARY Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Continuation Phase |
8.73; -0.14 | <.001 sig |
| SECONDARY Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Leukocyte Count - Continuation Phase |
6.40; 0.17 | .032 sig |
| SECONDARY Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Low Density Lipoprotein (LDL) Cholesterol (Direct) - Continuation Phase |
3.61; -0.14 | <.001 sig |
| SECONDARY Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Hemoglobin - Continuation Phase |
20.73; -0.18 | <.001 sig |
| SECONDARY Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Volume (MCV) - Continuation Phase |
89.33; 0.45 | .028 sig |
| SECONDARY Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Monocytes - Continuation Phase |
0.35; 0.02 | .008 sig |
| SECONDARY Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Continuation Phase |
72.47; -0.38 | .046 sig |
| SECONDARY Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Alanine Aminotransferase (ALT) - Maintenance Phase |
21.81; 22.12; 2.52; -0.38 | 0.035 sig |
| SECONDARY Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Maintenance Phase |
2.43; 2.43; -0.04; -0.01 | 0.011 sig |
| SECONDARY Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Glucose - Maintenance Phase |
5.40; 5.47; 0.07; 0.03; 5.68; 5.74 | 0.744 |
| SECONDARY Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase |
349; 150; 79; 76; 76; 60 | — |
| SECONDARY Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase |
102; 83; 59; 21; 12; 6 | — |
Summary
The purpose of this study is to assess the efficacy and safety of duloxetine compared with placebo in the prevention of depressive recurrences among patients with recurrent major depressive disorder.
Eligibility Criteria
Inclusion Criteria
- Patient must be at least 18 years old.
- Patient must be diagnosed with depression and have had previous episodes of depression.
- Patient must sign informed consent.
Exclusion Criteria
- Female and pregnant or breastfeeding.
- History of bipolar disorder, schizophrenia, or other psychotic disorders.
- Suffer from a serious medical illness (other than depression) or abnormal laboratory result that would require a change in medication, intervention, or hospitalization.
- Have been treated with a medication called monoamine oxidase inhibitor (MAOI) within 14 days of the start of the study, or potential need to use a MAOI within 5 days of finishing the study.
- Have taken an antidepressant called fluoxetine within 30 days of the start of the study.
Data sourced from ClinicalTrials.gov (NCT00105989). 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.