Phase 4
Completed N=750
A Study Comparing Duloxetine to Other Antidepressants in the Treatment of Severe Depression
Source: ClinicalTrials.gov NCT00666757 ↗Enrolled (actual)
750
Serious AEs
1.3%
Results posted
Jun 2010
Primary outcomePrimary: Probability of Remission [16-item Quick Inventory of Depressive Symptomatology (QIDS-SR) Score Less Than or Equal to 5 at 12-Week Endpoint] — 0.36; 0.32 Probability of remission — p=0.26
Summary
The purpose of this study is to compare duloxetine with other antidepressants in the treatment of severe depression.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Probability of Remission [16-item Quick Inventory of Depressive Symptomatology (QIDS-SR) Score Less Than or Equal to 5 at 12-Week Endpoint] |
0.36; 0.32 | 0.26 |
| SECONDARY Change From Baseline in QIDS-SR Total Score at 12-Week Endpoint (Mood Measure) |
-13.4; -12.6 | 0.07 |
| SECONDARY Probability of Remission [17-item Hamilton Depression Rating Scale (HAMD-17) (Mood Measure) Less Than or Equal to 7 at 12-Week Endpoint] |
0.53; 0.44 | 0.03 sig |
| SECONDARY Probability of Response [QIDS-SR Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint] |
0.71; 0.64 | 0.09 |
| SECONDARY Probability of Response [HAMD-17 Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint] |
0.73; 0.61 | 0.001 sig |
| SECONDARY Change From Baseline in HAMD-17 Total Score at 12-Week Endpoint (Mood Measure) |
-17.03; -15.3 | 0.002 sig |
| SECONDARY Change From Baseline in HAMD-17 Anxiety/Somatization Subscale Score at 12-Week Endpoint (Mood Measure) |
-4.89; -4.24 | 0.001 sig |
| SECONDARY Change From Baseline in HAMD-17 Maier Subscale Score at 12-Week Endpoint (Mood Measure) |
-9.01; -8.16 | 0.003 sig |
| SECONDARY Change From Baseline in HAMD-17 Bech Subscale Score at 12-Week Endpoint (Mood Measure) |
-9.21; -8.40 | 0.01 sig |
| SECONDARY Change From Baseline in HAMD-17 Retardation Subscale Score at 12-Week Endpoint (Mood Measure) |
-5.99; -5.49 | 0.02 sig |
| SECONDARY Change From Baseline in HAMD-17 Sleep Subscale Score at 12-Week Endpoint (Mood Measure) |
-2.77; -2.58 | 0.20 |
| SECONDARY Change From Baseline in Brief Pain Inventory (BPI) Average 24-hour Pain Score, in Particpants With a Baseline BPI Average 24-hour Pain Score of 3 or Greater, at 12-Week Endpoint (Pain Measure) |
-2.95; -2.39 | 0.03 sig |
| SECONDARY Change From Baseline in BPI Average 24 Hour Pain Score at 12-Week Endpoint (Pain Measure) |
-1.83; -1.43 | 0.03 sig |
| SECONDARY Change From Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score at 12-Week Endpoint (Functional Outcome Measure) |
-13.56; -11.53 | 0.002 sig |
| SECONDARY Change From Baseline in SDS Work/School Item Score at 12-Week Endpoint (Functional Outcome Measure) |
-4.52; -3.85 | 0.01 sig |
| SECONDARY Change From Baseline in Sheehan Disability Scale (SDS) Family/Home Item Score at Week-12 Endpoint (Functional Outcome Measure) |
-4.51; -3.94 | 0.02 sig |
| SECONDARY Change From Baseline in SDS Social Item Score at 12-Week Endpoint (Functional Outcome Measure) |
-4.69; -4.04 | 0.01 sig |
| SECONDARY Change From Baseline in Systolic Blood Pressure at Week-12 Endpoint |
0.58; 0.55 | 0.97 |
| SECONDARY Change From Baseline in Diastolic Blood Pressure at Week-12 Endpoint |
-0.14; 0.45 | 0.32 |
| SECONDARY Change From Baseline in Pulse Rate at Week-12 Endpoint |
2.74; 0.47 | 0.002 sig |
| SECONDARY Change From Baseline in Weight at Week-12 Endpoint |
-0.32; -0.17 | 0.53 |
Eligibility Criteria
Inclusion criteria
- At least 18 years of age
- Have major depression and are currently in a severe depressive episode
- Have a degree of understanding such that patient can communicate with the investigator and study staff
- All females must test negative for pregnancy
- Females of childbearing potential must use reliable method of birth control during the study and for 1 month after taking the last dose of study drug
Exclusion criteria
- Have not responded to duloxetine for depression in the past
- Have a history of bipolar disorder, a psychotic disorder (such as schizophrenia), a cognitive disorder (such as moderate or severe dementia), or obsessive-compulsive disorder (OCD)
- Are at significant risk for suicide
- Have not responded to 2 or more adequate trials of antidepressant medications during the current depressive episode
- Have a serious, unstable medical condition
- Have a current or recent history of substance abuse or dependence
- Have had electroconvulsive therapy (ECT), transcranial magnetic stimulation (rTMS), or vagus nerve stimulation (VNS) in the past year
- Have started psychotherapy within 6 weeks prior to study entry
- Have a serious medical illness or clinically significant laboratory abnormality that is not stabilized or is anticipated, in the judgment of the investigator, to require hospitalization or use of an excluded medication during the course of the study
Data sourced from ClinicalTrials.gov (NCT00666757). 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.