Phase 4
N=483
A Study of Patients With Major Depressive Disorder and Residual Apathy
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00985504 ↗Enrolled (actual)
483
Serious AEs
1.2%
Results posted
Oct 2011
Primary outcome: Primary: Change From Baseline in the Apathy Evaluation Scale - Clinician Rated Version (AES-C) Total Score at Week 8 — -13.88; -13.50 units on a scale — p=0.612
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Duloxetine (Drug); Escitalopram (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Apathy Evaluation Scale - Clinician Rated Version (AES-C) Total Score at Week 8 |
-13.88; -13.50 | 0.612 |
| SECONDARY Change From Baseline in the Apathy Evaluation Scale-Clinician Rated Version (AES-C) Subscale Scores at Week 8 |
-6.49; -6.25; -3.35; -3.25; -1.66; -1.58 | 0.504 |
| SECONDARY Change From Baseline in the Rothschild Scale for Antidepressant Tachyphylaxis (RSAT) Total and Individual Item Scores at Week 8 |
-5.50; -4.98; -1.33; -1.19; -1.41; -1.29 | 0.157 |
| SECONDARY Patient's Global Impressions of Improvement Scale (PGI-I) Rating Scale Score at Week 8 |
2.59; 2.55 | 0.723 |
| SECONDARY Change From Baseline in the Clinical Global Impression of Severity (CGI-S) Rating Scale at Week 8 |
-0.86; -0.93 | 0.410 |
| SECONDARY Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Item 8 (Inability to Feel) at Week 8 |
-4.21; -4.14; -1.01; -0.90 | 0.880 |
| SECONDARY Change From Baseline in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total and Item Scores at Week 8 |
-6.96; -6.91; -1.34; -1.35; -0.96; -1.00 | 0.910 |
| SECONDARY Change From Baseline in the Sheehan Disability Scale (SDS) Total and Individual Scores at Week 8 |
-7.55; -7.67; -2.42; -2.29; -2.51; -2.67 | 0.821 |
| SECONDARY Percentage of Participants Who Relapsed During 8 Weeks |
11.9; 11.0 | 0.776 |
| SECONDARY Number of Days From Baseline to Relapse as Defined by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score ≥16 During 8 Weeks |
4.00; 4.00; 81.00; 68.00 | 0.691 |
| SECONDARY Percentage of Participants Who Discontinue Due to Lack of Efficacy During 8 Weeks |
2.0; 1.3 | 0.724 |
Summary
The purpose of this study is to provide a comparison of the apathy, depression, and functional outcomes associated with switching to duloxetine or escitalopram in patients who have previously responded to treatment with a selective serotonin reuptake inhibitor (SSRI) for major depressive disorder and who have residual apathy in the absence of depressed mood.
Eligibility Criteria
Inclusion Criteria
- Have received treatment with an SSRI (escitalopram, sertraline, paroxetine, or citalopram) for major depressive disorder
- Females of child-bearing potential to test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a reliable method of birth control
- Apathy Evaluation Scale - Clinician Rated Version (AES-C) total score >30 at screening and randomization.
- Montgomery-Asberg Depression Rating Scale (MADRS) total score ≤15 and Item 1 (apparent sadness) score of <2 at screening and randomization.
- Have a level of understanding sufficient to provide informed consent and to communicate with the investigators, study coordinator, and site personnel.
Exclusion Criteria
- Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device
- Have previously completed or withdrawn from this study or any other study investigating duloxetine.
- Have had previous lack of response to an adequate trial of duloxetine within the past 12 months or escitalopram at any time.
- Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV), diagnosis of mania, bipolar disorder, treatment resistant depression or psychosis; or current suicide risk
- Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision(DSM-IV-TR),substance abuse or dependence within the 6 months
- Presence of an Axis II disorder
- Monoamine oxidase inhibitor (MAOI) treatment within 14 days prior to randomization or the potential need to use an MAOI during the study
- Positive urine drug screen for any substance of abuse or excluded medication.
- Are pregnant or breast-feeding.
- Serious medical illness, requires hospitalization during the study
- Have uncontrolled narrow-angle glaucoma.
- Have acute liver injury or severe cirrhosis
- Abnormal thyroid stimulating hormone (TSH) concentration
- Amphetamines, dopaminergic medications or modafinil within 14 days prior to randomization or potential need to use such medications during the study or within 14 days of discontinuation of study drug.
Data sourced from ClinicalTrials.gov (NCT00985504). 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.