Late-life Depression and Cerebral Perfusion

This study has been withdrawn prior to enrollment.
(This was an initial unfunded pilot project stopped after similar studies were funded.)
Sponsor:
Information provided by (Responsible Party):
Warren Taylor, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01751828
First received: December 12, 2012
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Depression
Drug: Sertraline

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Late-life Depression and Cerebral Perfusion

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Montgomery-Asberg Depression Rating Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quick Inventory of Depressive Symptoms (QIDS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: December 2012
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sertraline
Open-label sertraline, 8 week trial, dosing from 50mg to 200mg daily.
Drug: Sertraline
Other Name: Zoloft

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01751828

Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Warren D Taylor, MD, MHSc Vanderbilt University
  More Information

No publications provided

Responsible Party: Warren Taylor, Associate Professor of Clinical Psychiatry, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01751828     History of Changes
Other Study ID Numbers: 121648
Study First Received: December 12, 2012
Last Updated: July 30, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
Depression
Major Depressive Disorder

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sertraline
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014