Phase 4
Completed N=370
A Study Comparing the Efficacy and Safety of Duloxetine and Placebo for the Treatment of Depression in Elderly Patients
Source: ClinicalTrials.gov NCT00406848 ↗Enrolled (actual)
370
Serious AEs
4.4%
Results posted
Sep 2010
Primary outcomePrimary: Change From Baseline to 13 Weeks in Hamilton Depression Rating Scale (HAMD-17) Maier Subscale — -4.34; -3.90 units on a scale — p=0.397
Summary
The purpose of this study is to compare the efficacy and safety of duloxetine 60 mg once daily to placebo on depression in elderly patients (greater than or equal to 65 years of age). Patients who do not respond in the first 13 weeks will be eligible for rescue using pre-defined criteria. Patients randomized to duloxetine 60 mg/day meeting the rescue criteria will be increased to 120 mg/day. Patients randomized to the placebo arm meeting the rescue criteria will be assigned to duloxetine 60 mg/day.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to 13 Weeks in Hamilton Depression Rating Scale (HAMD-17) Maier Subscale |
-4.34; -3.90 | 0.397 |
| SECONDARY Change From Baseline on the 30-item Geriatric Depression Scale (GDS) |
-6.01; -4.53; -7.02; -3.66 | 0.115 |
| SECONDARY Change From Baseline in the HAMD-17 Total Score, Subscales, and Individual Items |
-7.42; -7.15; -8.98; -7.00; -5.31; -4.17 | 0.773 |
| SECONDARY Change From Baseline in the Brief Pain Inventory (BPI) Severity and Interference Scores |
-0.66; -0.18; -0.74; -0.36; -0.47; -0.00 | 0.034 sig |
| SECONDARY Change From Baseline in the Numeric Rating Scales (NRS) for Pain Item Scores |
-0.65; -0.05; -0.67; -0.40; -0.32; 0.01 | .005 sig |
| SECONDARY Patient's Global Impression of Improvement (PGI-I) at 13 Weeks and 25 Weeks |
2.74; 3.02; 2.38; 2.85 | 0.214 |
| SECONDARY Change From Baseline in the Clinical Global Impression-Severity (CGI-S) |
-1.25; -1.04; -1.65; -1.17 | .162 |
| SECONDARY Change From Baseline in the Mini-Mental State Exam (MMSE) |
0.12; 0.24; 0.29; 0.35 | 0.555 |
| SECONDARY Change From Baseline in the Quality of Life, Enjoyment, and Satisfaction Questionnaire (Q-LES-Q-SF) |
6.58; 5.27; 7.44; 4.79 | 0.255 |
| SECONDARY Probability of Remission as Measured by the HAMD-17 Total Score ≤7 and ≤10 |
0.37; 0.33; 0.54; 0.49; 0.54; 0.53 | 0.706 |
| SECONDARY Probability of Response at Endpoint as Measured by ≥50% Improvement in the HAMD-17 Total Score |
0.44; 0.48; 0.61; 0.72 | 0.664 |
| SECONDARY Probability of Remission as Measured by the HAMD-17 Total Score ≤7 and ≤10 by Medical Comorbidity Severity as Assessed by the Cumulative Illness Rating Scale-Geriatric Version (CIRS-G) |
0.44; 0.44; 0.33; 0.20; 0.53; 0.52 | — |
| SECONDARY Probability of Efficacy Onset as Measured by at Least 20% Sustained Reduction From Baseline in the HAMD-17 Maier Subscale at Week 3 |
0.43; 0.30 | 0.036 sig |
| SECONDARY Change From Baseline in Supine Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) |
0.19; -0.58; 1.89; -1.58; 2.22; 0.54 | 0.637 |
| SECONDARY Change From Baseline in Pulse Rate |
0.03; -1.56; 2.10; -0.87 | 0.121 |
| SECONDARY Change From Baseline in Weight |
-0.86; 0.06; -0.69; -0.03 | 0.003 sig |
| SECONDARY Number of Participants With Abnormal Vital Signs and Weight at Any Time During the Study |
22; 5; 10; 4; 28; 7 | 0.135 |
| SECONDARY Number of Participants Experiencing Sustained Hypertension (SH) or Orthostatic Hypotension (OH) |
5; 1; 57; 21 | 0.668 |
| SECONDARY Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation |
38; 7; 0; 3; 0; 0 | — |
| SECONDARY Change From Baseline in Laboratory Values - Platelet Count |
7.92; -4.66; 10.58; -6.11 | 0.003 sig |
| SECONDARY Change From Baseline in Laboratory Values - Uric Acid |
-11.63; 9.30; -9.93; 10.26 | <0.001 sig |
| SECONDARY Change From Baseline in Laboratory Values - Erythrocyte Count |
-0.04; 0.01 | 0.014 sig |
| SECONDARY Change From Baseline in Laboratory Values - Hemoglobin, Mean Cell Hemoglobin Concentration (MCHC) |
-0.11; 0.01; -0.20; -0.02 | 0.019 sig |
| SECONDARY Change From Baseline in Laboratory Values - Chloride and Fasting Glucose |
-0.63; 0.01; 0.37; -0.11 | 0.040 sig |
| SECONDARY Number of Participants With Abnormal Laboratory Values - Low Leukocyte Count |
11; 0 | 0.019 sig |
| SECONDARY Change From Baseline in Electrocardiograms |
-11.80; -10.95; -5.02; -5.91; -1.38; -3.78 | 0.815 |
| SECONDARY Number of Participants With Successful Treatment Outcome |
55; 17; 74; 21 | 0.110 |
| SECONDARY Change From Baseline on Cognitive Test Scores: Verbal Learning and Recall Test (VLRT), Symbol Digit Substitution Test (SDST), Trail Making Test (Part B), 2-Digit Cancellation Test (2DCT), and the Composite Cognitive Score Derived From the Above Scores |
-0.38; 0.01; 0.96; 0.31; -0.06; -0.04 | 0.511 |
Eligibility Criteria
Inclusion Criteria
- Are male or female outpatients at least 65 years of age 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 Mini Mental Score Exam (MMSE) score of at least 20 at Visit 1
- Have a degree of understanding such that the patient can 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
- Have any prior history of bipolar disorder, panic disorder, psychosis, schizophrenia, or obsessive-compulsive disorder
- Have any current (within the past 12 months) DSM-IV-TR primary Axis I diagnosis other than MDD
- Have moderate to severe dementia
- Have a serious medical illness, including any cardiovascular (CV), hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality that is not stabilized or is anticipated to require hospitalization within 6 months, in the opinion of the investigator
Data sourced from ClinicalTrials.gov (NCT00406848). 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.