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NCT01658228 · ClinicalTrials.gov registry record · Phase 4
Combination Treatment Study for Memory Impairment and Depression
A Phase 4 study of Depression and Mild Cognitive Impairment, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 86
- Enrollment target
- 2
- Study locations
NCT01658228 is a Phase 4 study of Depression and Mild Cognitive Impairment that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 86 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (89% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT01658228, a Phase 4 study of Depression and Mild Cognitive Impairment, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 86 participants
- Enrollment target
- 2
- Study locations
Study Summary
Patients presenting with depression (DEP) and cognitive impairment (CI), represent a unique, understudied population that is difficult to diagnose, treat and estimate prognosis. Our pilot data, supported by the literature, suggest that many DEP-CI patients show cognitive decline and often convert to dementia, primarily Alzheimer's disease (AD). In DEP-CI, there is a lack of data on treatment response of mood symptoms to antidepressant treatment and particularly of cognitive deficits to cognitive enhancer treatment. Our initial pilot data in a double-blind study showed that donepezil was superior to placebo in improving memory in antidepressant-treated DEP-CI patients. In a second pilot study, open label es-citalopram plus memantine treatment led to a low rate of conversion to dementia. In this proposed pilot clinical trial, the investigators will evaluate, treat and follow a broad sample of 80 DEP-CI patients at NYSPI/Columbia University Medical Center (N = 40) and Duke University Medical Center (N = 40). Recruitment will be from clinics and/or advertisements. In the treatment protocol, all 80 DEP-CI patients will receive baseline mood and memory assessments and open antidepressant treatment with citalopram for 8 weeks. At 8 weeks, repeat assessment will occur and patients whose depression has responded to citalopram will be randomized to add-on donepezil or placebo. Non-responders to citalopram will receive open treatment with venlafaxine and will be randomized 8 weeks later (16 weeks of open antidepressant treatment) to add-on donepezil or placebo. Patients will be followed for a total period of 18 months with continuous open antidepressant treatment during the trial. Donepezil is being studied in order to increase the likelihood of obtaining a signal. If the results are positive, the investigators can begin clarifying the mechanism(s) in subsequent trials. Baseline apolipoprotein E e4 genotype, odor identification deficits, and MRI hippocampal and entorhinal co
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Donepezil
- DRUG Citalopram
- DRUG Venlafaxine
Study Locations (2)
New York
- New York State Psychiatric Institute - New York
North Carolina
- Duke University - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2011-09 |
| Est. Completion | 2016-01 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01658228
The ClinicalTrials.gov registry entry for NCT01658228 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (89% lower). The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Depression appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT01658228 reports 2 study locations spanning 2 distinct geographic areas - top geographies include New York, North Carolina.
Frequently Asked Questions
What is clinical trial NCT01658228 about?
NCT01658228 is a clinical study titled "Combination Treatment Study for Memory Impairment and Depression". Patients presenting with depression (DEP) and cognitive impairment (CI), represent a unique, understudied population that is difficult to diagnose, treat and estimate prognosis. Our pilot data, supported by the literature, suggest that many DEP-CI patients show cognitive decline and often convert to...
What is the current status of trial NCT01658228?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 86 participants. The study started on 2011-09. Estimated completion is 2016-01.
What conditions does trial NCT01658228 study?
This clinical trial studies the following conditions: Depression, Mild Cognitive Impairment.
What interventions are being tested in trial NCT01658228?
The interventions under investigation include: Placebo (DRUG), Donepezil (DRUG), Citalopram (DRUG), Venlafaxine (DRUG).
Who is sponsoring clinical trial NCT01658228?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01658228 being conducted?
This trial has 2 study locations across New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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