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Late-life Depression and Cerebral Perfusion

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ClinicalTrials.gov Identifier: NCT01751828
Recruitment Status : Withdrawn (This was an initial unfunded pilot project stopped after similar studies were funded.)
First Posted : December 18, 2012
Last Update Posted : July 31, 2013
Sponsor:
Information provided by (Responsible Party):
Warren Taylor, Vanderbilt University

Brief Summary:

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 or disease Intervention/treatment Phase
Depression Drug: Sertraline Not Applicable

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  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Late-life Depression and Cerebral Perfusion
Study Start Date : December 2012
Estimated Primary Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Sertraline
Open-label sertraline, 8 week trial, dosing from 50mg to 200mg daily.
Drug: Sertraline
Other Name: Zoloft



Primary Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Quick Inventory of Depressive Symptoms (QIDS) [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Warren Taylor, Associate Professor of Clinical Psychiatry, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01751828     History of Changes
Other Study ID Numbers: 121648
First Posted: December 18, 2012    Key Record Dates
Last Update Posted: July 31, 2013
Last Verified: July 2013

Keywords provided by Warren Taylor, Vanderbilt University:
Depression
Major Depressive Disorder

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sertraline
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs