Phase 4
N=130
Antidepressant Medication Plus Donepezil for Treating Late-life Depression
Depression · Dementia
Bottom Line
View on ClinicalTrials.gov: NCT00177671 ↗Enrolled (actual)
130
Serious AEs
3.1%
Results posted
Jun 2011
Primary outcome: Primary: Global Cognitive Performance — -0.47; -0.47; -0.23; -0.65 Z-score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Escitalopram (Drug); Donepezil (Drug); Venlafaxine (Drug); Placebo (Drug); Duloxetine (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Global Cognitive Performance |
-0.47; -0.47; -0.23; -0.65; -0.31; -0.56 | — |
| PRIMARY Cognitive Instrumental Activities of Daily Living (IADL) |
54.10; 61.82; 62.16; 54.35; 36.67; 47.22 | — |
| PRIMARY Number of Participants With Recurrence of Major Depression |
19; 11 | .05 |
Summary
This study will determine the effectiveness of combining escitalopram, venlafaxine, or duloxetine with donepezil, a medication used in Alzheimer's disease, in improving memory, concentration, attention, and problem solving abilities, and reducing the risk of depressive relapse in older individuals with depression.
Eligibility Criteria
Inclusion Criteria
- Current episode of major depression
- HRS-D 17-item score of 15 or higher
- Must be able to speak English
- Willing to discontinue other psychotropics
- Availability of family member/caregiver
- Hearing capacity adequate to respond to raised conversational voice
- Must have no formal diagnosis of dementia
Exclusion Criteria
- Meets DSM-IV criteria for bipolar disorder, schizophrenia, schizoaffective disorder, or a psychotic disorders
- Alcohol/drug abuse within 12 months of study entry
- History of treatment non-adherence in other clinic protocols
- History of non-response to citalopram in other clinic protocols
- History of non-tolerance to SSRI therapy
Data sourced from ClinicalTrials.gov (NCT00177671). 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.