Status:
COMPLETED
Memantine Plus Es-citalopram in Elderly Depressed Patients With Cognitive Impairment
Lead Sponsor:
New York State Psychiatric Institute
Conditions:
Mild Cognitive Impairment
Major Depressive Disorder
Eligibility:
All Genders
50-90 years
Phase:
PHASE2
PHASE3
Brief Summary
Alzheimer's disease (AD), the most common dementing disorder of later life, is a major cause of disability and death in the elderly. Although a number of theoretical causes exist, the etiology of AD i...
Detailed Description
The study is conducted in a sample of 35 elderly (50-90 years old) outpatients who meet study inclusion criteria for depression (DEP) (DSM-IV criteria for major depression, dysthymic disorder, or depr...
Eligibility Criteria
Inclusion
- Of either sex, age greater than 49 years old
- Meets criteria for both "depression" and "cognitive impairment".
- Study Criteria for "depression":
- i. Patients who meet DSM-IV criteria for Major Depression, Dysthymic Disorder, or Dysthymia symptoms criteria of minimum 6 month duration (not the 2 year DSM-IV criteria). ii. 24-item HAM-D greater than 13; and iii. Clinical Global Impression (CGI) for severity of Depression greater than 2 (absolute score at least mild to moderate depression on a 7-point scale)
- Study Criteria for "cognitive deficit":
- i. Subjective memory complaint ii.Mini Mental Status Exam (MMSE) greater than 24; and at least one of a, b, or c:
- less than 3 on MMSE 5 min delay on recall
- scores on 2 neuropsychological tests greater than 1 Standard Deviation (SD) below standardized norms, or
- score on 1 neuropsychological tests greater than 2 SD below standardized norms.
- Neuropsychological tests for inclusion criteria (subset of larger battery):
- Selective Reminding Test with delay Wechsler Memory Scale (WMS): Visual Reproduction - with delay, % savings from immed to delay Controlled Oral Word Association Test Trails B Digit symbol subtest of Wechsler Adult Intelligence Scale (WAIS)-III Continuous Performance Test iii. CGI for severity of Cognitive deficit greater than 2 (absolute score on a 7-point scale:1=no deficit to 7=severe deficit). iv. Clinical Dementia Rating (CDR) = 0 or 0.5
- Willing and capable of giving informed consent
Exclusion
- Meets Criteria for dementia (DSM-IV) or probable Alzheimer's disease by National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association criteria (NINCDS-ADRDA criteria)
- Meets criteria for:
- schizophrenia
- alcohol or substance dependence or abuse within the last 6 months.
- Suicidal attempt in last 6 months or current suicidal intent.
- Patients currently on an effective antidepressant medication
- Use of cholinesterase inhibitors in the last year.
- Neurological disease including stroke, epilepsy, or other neurodegenerative disorders.
- An acute, severe or unstable medical condition such as metastatic or active cancer, hepatic disease, or primary renal disease requiring dialysis.
- Patients who can not tolerate being tapered off antidepressant medication (i.e. greater than a 25% incr. in baseline HAM-D) or has a history indicating patient is unlikely to tolerate psychotropic washout.
- Patient with a history of non-response to Citalopram or es-citalopram
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01876823
Start Date
April 1 2006
End Date
March 1 2010
Last Update
October 24 2014
Active Locations (1)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032