Major Depressive Disorder Clinical Trial
Official title:
Frontal Hypoperfusion Effects on Antidepressant Outcomes in Late-Life Depression (R21)
Verified date | July 2016 |
Source | Vanderbilt University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The long-term goal of this line of research is to determine if decreased vascular reactivity and frontal hypoperfusion is associated with poor response antidepressants. Such perfusion deficits could contribute to antidepressant nonresponse as they would hinder improvements in dorsal system metabolism seen with antidepressant treatment. The objective of the current proposal is to determine if decreased vascular reactivity and frontal hypoperfusion in depressed elders predicts and persists with antidepressant nonremission. The investigators will pursue the primary aim testing the hypothesis that decreased reactivity and hypoperfusion, specifically in the dorsolateral prefrontal cortex and dorsal anterior cingulate cortex, predict antidepressant nonremission. The investigators will enroll 40 depressed elders who will complete clinical, cognitive, and MRI assessments before and after a 12-week open-label antidepressant trial of sertraline.
Status | Completed |
Enrollment | 29 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria: 1. Age 60 years or older. 2. Current diagnosis of major depressive disorder (DSM-IV-TR), single episode, recurrent or chronic, without psychotic features, as detected by MINI and clinical exam. 3. Minimum MADRS score = 15. 4. Mini-Mental State Exam = 22. 5. Ability to read and write English. Exclusion Criteria: 1. Current or past diagnoses of other Axis I psychiatric disorders, including panic disorder and substance dependence. 2. Any use of illicit substances (such as marijuana or cocaine) or abuse of prescription medications (such as benzodiazepines or opiates) within the last three months. 3. Presence of acute suicidality 4. Current or past psychosis 5. Known primary neurological disorder, including dementia, brain tumors, epilepsy, Parkinson's disease, or demyelinating diseases 6. Chronic untreated medical disorders (including but not limited to hypertension, hyperlipidemia, fibromyalgia, hypothyroidism, or any other disorder) where treatment is warranted 7. Need for continuous oxygen use or any medical disorder where the hypercapnia challenge would be contraindicated or put the subject at increased risk. This would include active respiratory disease, chronic angina or other unstable cardiac conditions. 8. Any physical or intellectual disability affecting completion of assessments 9. MRI contraindications 10. Electroconvulsive therapy in last 6 months 11. Use of fluoxetine in the last 6 weeks. Occasional use of benzodiazepines or non-benzodiazepine sedatives (such as zolpidem, eszopiclone, or zaleplon) during the last month is allowable. 12. Known allergy or hypersensitivity to sertraline 13. A failed therapeutic trial of sertraline in the current depressive episode (defined as at least 6 weeks of treatment at a daily dose of 100mg or higher) 14. Current or planned psychotherapy |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | MRI Arterial Spin Labeling (ASL) | This is a noninvasive approach to measuring cerebral perfusion. We will examine pre-treatment measures to determine if they predict subsequent response to sertraline as measured by the MADRS and QIDS-SR16 | Baseline | No |
Primary | Remission of depression | Montgomery-Asberg Depression Rating Scale (MADRS) is a measure of depression severity. This will be used to define remission as a score of 7 or less. | Week 12 | No |
Secondary | Change in depression severity | Change in depression severity will be measured by the MADRS and the Quick Inventory of Depressive Symptoms, Self-Rated (QIDS-SR16). The QIDS-SR16 is a self-report measure of depression severity. | Baseline to week 12, measured every 2 weeks | No |
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