Late-life Depression and Cerebral Perfusion
|ClinicalTrials.gov Identifier: NCT01751828|
Recruitment Status : Withdrawn (This was an initial unfunded pilot project stopped after similar studies were funded.)
First Posted : December 18, 2012
Last Update Posted : July 31, 2013
The long-term goal is to determine if decreased blood flow to the brain (cerebral hypoperfusion) is predictive of antidepressant outcomes in late-life depression (LLD). Studies in younger adult report that successful antidepressant treatment is associated with increases in cerebral blood flow, with no change in blood flow being observed in nonresponders. Thus cerebral hypoperfusion may be a biomarker of poor response to antidepressants. In LLD, this may occur secondarily to underlying vascular disease. If LLD is characterized by cerebral hypoperfusion and it does have predictive power to identify individuals who will poorly respond to conventional antidepressants, this would support the study of interventions that improve cerebral perfusion and may improve antidepressant outcomes.
As an initial step in this research, this pilot study will utilize MRI to examine if resting blood flow deficits predict and persist with antidepressant nonremission in an elderly population. The rationale for this proposal is that it will guide the design and power requirements of a larger, definitive trial examining the relationship between cerebral perfusion and depression outcomes. Importantly, support for this mechanism being linked to LLD would also support studies examining the antidepressant efficacy of drugs that may improve cerebral perfusion.
The primary purpose of this pilot study is a) to demonstrate feasibility by recruiting, scanning, and treating depressed elders; and b) to acquire preliminary data for competitive grant submissions.
SPECIFIC AIM: To use MRI to test for differences in cerebral perfusion between individuals who do and do not remit to a 8-week course of sertraline.
|Condition or disease||Intervention/treatment||Phase|
|Depression||Drug: Sertraline||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Late-life Depression and Cerebral Perfusion|
|Study Start Date :||December 2012|
|Estimated Primary Completion Date :||August 2013|
Open-label sertraline, 8 week trial, dosing from 50mg to 200mg daily.
Other Name: Zoloft
- Montgomery-Asberg Depression Rating Scale [ Time Frame: 8 weeks ]
- Quick Inventory of Depressive Symptoms (QIDS) [ Time Frame: 8 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01751828
|United States, Tennessee|
|Nashville, Tennessee, United States, 37212|
|Principal Investigator:||Warren D Taylor, MD, MHSc||Vanderbilt University|