Combination Treatment Study for Memory Impairment and Depression
Combination Treatment Study for Memory Impairment and Depression
Overall Status:
Recruiting
Brief Description:
Pilot study results suggest that older adults with both depression and cognitive impairment (DEP-CI) show cognitive decline and often convert to dementia, primarily Alzheimer's disease. In this pilot clinical trial, older adults with DEP-CI will be treated with the antidepressant citalopram for 8 weeks. Those who respond to treatment will then take add-on donepezil or a placebo. Non-responders to citalopram will be treated with the antidepressant venlafaxine for 8 weeks, then add-on donepezil or a placebo. Investigators seek to clarify how donepezil works in older adults with DEP-CI. The ultimate goal is to kmprove cognition and delay conversion to dementia in this high-risk group.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
55 Years | 95 Years | Both | No |
Inclusion Criteria:
- Meet criteria for both depression and cognitive impairment as follows
- Depression: Meet DSM-IV symptom criteria for major depression or dysthymia for at least 6 months; 24-item HAM-D ≥14
- Cognitive impairment: Have subjective memory or other cognitive complaints; score of <11 on the Logical Memory II (Delayed Paragraph Recall, Paragraph A) test from the Wechsler Memory Scale-Revised; Folstein Mini Mental State (MMSE) score ≥21; Clinical Dementia Rating (CDR) of 0.5 on the memory item and global rating of 0.5
- Family member or close friend who consents to serve as informant during the study; this can be a telephone informant in the case of patients who do not have a live-in informant or close significant other.
Exclusion Criteria:
- Meet criteria for dementia (DSM-IV) or probable Alzheimer's disease (NINCDS-ADRDA)
- Meet DSM-IV TR criteria for schizophrenia, schizoaffective disorder, psychotic depression or other psychosis; bipolar I disorder; alcohol or substance dependence or abuse (current or within past 6 months); active suicidal ideation or suicidal attempt in last 6 months
- Clinical stroke with residual neurological deficits
- Use of medications known to have a negative impact on cognition, e.g., benzodiazepines in lorazepam equivalents ≥ 2 mg daily, narcotics, or anticholinergics
- Acute, severe, or unstable medical condition
- Presence of any of the following disorders: Central nervous system (CNS) infection, with evidence of meningitis, encephalitis, or other infectious process; post-traumatic dementia, defined as dementia with a clear temporal relationship to a severe head injury where consciousness was lost; Huntington's disease; multiple sclerosis; Parkinson's disease; other neurologic disorders with focal signs, e.g., amyotrophic lateral sclerosis
- Mental retardation
- Contraindication to MRI scan, e.g., pacemaker, metal implants following surgery (MRI is optional)
Detailed Description:
Depression (DEP) and cognitive impairment (CI) are common neuropsychiatric disorders in older adults. Since DEP in patients with CI increases the risk of conversion to dementia, treatment strategies for DEP-CI have implications beyond acute treatment with antidepressants. The long-term prognosis of individuals with DEP-CI remains unclear, as there is a lack of data on response of mood symptoms to antidepressant treatment and of cognitive deficits to cognitive enhancer treatment.
The primary aim of the study is to assess changes in cognitive status over 18 months in antidepressant-treated older adults with DEP-CI, comparing donepezil to a placebo. We hypothesize that antidepressant-treated participants on donepezil will show a lower rate of conversion to dementia, compared with participants treated with a placebo. The study population consists of 80 older adults with DEP-CI who have been treated with antidepressants. Participants who respond to treatment with the antidepressant citalopram will then receive add-on donepezil or a placebo. Non-responders to citalopram will receive treatment with the antidepressant venlafaxine, then add-on donepezil or a placebo. if a participant does not respond to either citalopram or venlafaxine, the study physician may choose to treat him or her with an alternative antidepressant.
In addition, the investigators will explore apolipoprotein E ε4 genotype, MRI hippocampal and entorhinal cortex atrophy, and odor identification deficits as biomarkers that moderate response to treatment.
Locations:
| Map Marker | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 40.8409822, -73.9447994 | New York State Psychiatric Institute | New York | New York | 10032 | Recruiting | Kristina M D'Antonio 212-543-5956 dantonk@nyspi.columbia.edu |
Geolocation is 36.0038131, -78.9387241 | Duke University | Durham | North Carolina | 27710 | Recruiting | Hala Husn 919-684-5929 hala.husn@duke.edu |
Lead Sponsor:
| Agency |
|---|
New York State Psychiatric Institute |
Collaborator Sponsor:
| Agency |
|---|
National Institute on Aging |
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Davangere Devanand, MD | Principal Investigator | Columbia University |
Gregory Pelton, MD | Study Director | Columbia University |
Steven Roose, MD | Study Director | Columbia University |
Murali Doraiswamy, MD | Study Director | Duke University |
Study Contact:
| Name | Phone | |
|---|---|---|
Kristina M. D'Antonio | 212-543-5956 |
Locations
ClinicalTrials.gov ID
NCT01658228 (follow link to view full record on ct.gov in new window)
Official Title:
Pilot Combination Treatment Trial of Mild Cognitive Impairment With Depression
Study Start Date:
September 2011
Study End Date:
August 2014
Disease Stage:
Early
Enrollment:
80
