Status:
TERMINATED
Effects of Cerebral Hypoperfusion and Its Reversal on Late-Life Depression
Lead Sponsor:
Vanderbilt University
Conditions:
Depression
Hypertension
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief Summary
This pilot proposal will test the hypothesis that altered cerebral vessel reactivity and cerebral hypoperfusion (decreased blood flow to the brain) is a core mechanism underlying the relationship betw...
Detailed Description
This study will examine how magnetic resonance imaging (MRI) measures of cerebral perfusion relate to antidepressant response. There are two phases to the study. In the first phase, we will examine ho...
Eligibility Criteria
Inclusion
- Age 60 years or older
- Diagnosis of Major Depressive Disorder, single or recurrent episode, without psychotic features by Diagnostic and Statistical Manual IV Text Revision (DSMIV-TR) criteria
- Presence of hypertension (defined as systolic \> 140 or diastolic \> 90 or currently receiving antihypertensive therapy)
- Minimum depression severity of ≥ 15 on the Montgomery-Asberg Depression Rating Scale (MADRS)
- Cognitively intact or with mild cognitive deficits, with a minimum score ≥ 23 on the Montreal Cognitive Assessment (MoCA).
Exclusion
- Other psychiatric Axis I disorders
- Acute suicidality
- Electroconvulsive therapy in the last 6 months
- Primary neurological disorder, including dementia and stroke
- Significant cardiovascular disease, specifically diagnosis of congestive heart failure, known bilateral renal artery stenosis, symptomatic hypotension, or critical aortic or mitral stenosis
- Myocardial infarction or open-heart surgery in last 6 weeks
- Serum creatinine ≥ 265 micromol /L
- Serum potassium ≥ 5.5 mmol/L
- MRI contraindications
- Known allergy to sertraline or candesartan specifically or known allergy to other SSRIs or ARBs.
- History of prolonged (\> 3 weeks) or self-described severe discontinuation syndrome in the past after stopping an antidepressant.
- Current use of an angiotensin receptor blocker
- Current or planned psychotherapy
- 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 acute respiratory disease, chronic angina, or other unstable cardiac conditions.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01794455
Start Date
May 1 2013
End Date
March 1 2015
Last Update
October 20 2016
Active Locations (1)
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1
Vanderbilt Psychiatric Hospital
Nashville, Tennessee, United States, 37212