Late-life Depression and Cerebral Perfusion

July 30, 2013 updated by: Warren Taylor, Vanderbilt University

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

After providing informed consent, participants will complete brain MRI and memory testing. If they are currently taking an antidepressant and are not doing well on it, they will be taken off it. Participants will then start sertraline, a commercially available antidepressants. They will be monitored for response and side effects for 8 weeks and doses adjusted as needed. After the study, we will examine how differences in brain blood flow may predict who does and does not respond to sertraline.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 60 years or older.
  • Current diagnosis of major depressive disorder (DSM-IV-TR), recurrent or chronic, without psychotic features
  • Minimum depression severity of Montgomery Asberg Depression Rating Scale (MADRS) score ≥ 15
  • Cognitively intact by Montreal Cognitive Assessment (MoCA) score ≥ 23
  • Ability to read and write English

Exclusion Criteria:

  • Other current or past psychiatric diagnoses
  • Any use of illicit substances or abuse of prescription medications
  • Presence of acute suicidality
  • Current or past psychotic symptoms
  • Known primary neurological disorder, including dementia
  • Chronic untreated medical disorders where treatment is warranted
  • Any contraindication to MRI, such as metal in the body
  • Electroconvulsive therapy in the last 6 months
  • Use of antidepressants or other psychiatric medications in the last month.
  • Known allergy to sertraline
  • A failed therapeutic trial of sertraline in the current depressive episode
  • Current or planned psychotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sertraline
Open-label sertraline, 8 week trial, dosing from 50mg to 200mg daily.
Drug: Sertraline
Other Names:
  • Zoloft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Montgomery-Asberg Depression Rating Scale
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Quick Inventory of Depressive Symptoms (QIDS)
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Investigators

  • Principal Investigator: Warren D Taylor, MD, MHSc, Vanderbilt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Anticipated)

August 1, 2013

Study Registration Dates

First Submitted

December 12, 2012

First Submitted That Met QC Criteria

December 13, 2012

First Posted (Estimate)

December 18, 2012

Study Record Updates

Last Update Posted (Estimate)

July 31, 2013

Last Update Submitted That Met QC Criteria

July 30, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 121648

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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