Status:
COMPLETED
Frontal Hypoperfusion Effects on Antidepressant Outcomes in Late-Life Depression
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief Summary
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 c...
Detailed Description
The long-term goal of this line of research is to determine if in late-life depression (LLD), cerebrovascular dysregulation is predictive of antidepressant outcomes. The investigators hypothesize that...
Eligibility Criteria
Inclusion
- Age 60 years or older.
- Current diagnosis of major depressive disorder (DSM-IV-TR), single episode, recurrent or chronic, without psychotic features, as detected by MINI and clinical exam.
- Minimum MADRS score ≥ 15.
- Mini-Mental State Exam ≥ 22.
- Ability to read and write English.
Exclusion
- Current or past diagnoses of other Axis I psychiatric disorders, including panic disorder and substance dependence.
- 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.
- Presence of acute suicidality
- Current or past psychosis
- Known primary neurological disorder, including dementia, brain tumors, epilepsy, Parkinson's disease, or demyelinating diseases
- Chronic untreated medical disorders (including but not limited to hypertension, hyperlipidemia, fibromyalgia, hypothyroidism, or any other disorder) where treatment is warranted
- 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.
- Any physical or intellectual disability affecting completion of assessments
- MRI contraindications
- Electroconvulsive therapy in last 6 months
- 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.
- Known allergy or hypersensitivity to sertraline
- 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)
- Current or planned psychotherapy
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01896934
Start Date
July 1 2013
End Date
June 1 2016
Last Update
July 21 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Vanderbilt University
Nashville, Tennessee, United States, 37212