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NCT01305889 · ClinicalTrials.gov registry record · NA
The Effect of Problem Solving Therapy and Antidepressant Therapy on Cerebral Perfusion and Brain Derived Neurotropic Factor (BDNF) in Depressed Elders
A NA study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- NA
- Development phase
- 19
- Enrollment target
NCT01305889 is a NA study that has completed, run by University of California, San Francisco. The registered enrollment target is 19 participants.
The verdict
NCT01305889, a NA study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- NA
- Development phase
- 19 participants
- Enrollment target
Study Summary
The focus of this study is to gather preliminary data regarding the effects of a psychological therapy-Problem Solving Therapy-and an antidepressant medication-sertraline-on 1) cerebral perfusion (CP), 2) brain derived neurotrophic factor (BDNF), and 3) measures of cognitive function in subjects with late life major depression (LLMD). This research goal will be achieved by recruiting 38 individuals over the age of 65 with LLMD. The primary outcomes will be change in CP, change in BDNF, and change in cognitive measures from baseline to the end of 12 weeks of either therapy. We will also examine predictors of treatment outcome including severity of executive dysfunction, baseline BDNF concentrations, and baseline CP measures. The baseline neuropsychological testing, brain imaging, and depression assessment will be obtained in a companion study (PI S. Mackin; CHR #H42689-32681-01) that is IRB approved and is already in progress. In the current study a baseline serum BDNF level will be added to Dr. Mackin's protocol. Patients will then receive either 12 weeks of Problem Solving Therapy or antidepressant treatment with sertraline. Both treatments are evidence based and commonly administered in our clinic. Outcome variables will be measures of depression severity, the BDNF serum concentration, cerebral perfusion using a MRI arterial spin labeling (ASL) technique and cognitive changes in memory and executive dysfunction. This is a preliminary or pilot study. The primary objectives are to determine if the methods appear feasible and to determine if change in BDNF or CP occur after treatment and secondarily to determine if there are changes in cognitive functioning. The study is not powered to show differences between treatments. The hypotheses are 1) PST will result in increased perfusion in frontal regions of the brain but that frontal perfusion will not change with sertraline; 2)sertraline will result in an increase in BDNF but PST will not. Change in cognitive measures o
Interventions
- DRUG Sertraline
- BEHAVIORAL problem solving therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2011-03 |
| Est. Completion | 2018-02-16 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01305889
The ClinicalTrials.gov registry entry for NCT01305889 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sertraline is the first listed.
NCT01305889 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01305889 about?
NCT01305889 is a clinical study titled "The Effect of Problem Solving Therapy and Antidepressant Therapy on Cerebral Perfusion and Brain Derived Neurotropic Factor (BDNF) in Depressed Elders". The focus of this study is to gather preliminary data regarding the effects of a psychological therapy-Problem Solving Therapy-and an antidepressant medication-sertraline-on 1) cerebral perfusion (CP), 2) brain derived neurotrophic factor (BDNF), and 3) measures of cognitive function in subjects wit...
What is the current status of trial NCT01305889?
This trial is currently completed. It is a NA study. The enrollment target is 19 participants. The study started on 2011-03. Estimated completion is 2018-02-16.
What interventions are being tested in trial NCT01305889?
The interventions under investigation include: Sertraline (DRUG), problem solving therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT01305889?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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