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Treatment Outcome of Vascular Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00045773
Recruitment Status : Completed
First Posted : September 11, 2002
Last Update Posted : October 31, 2017
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Duke University
Information provided by (Responsible Party):
Yvette Sheline, University of Pennsylvania

Tracking Information
First Submitted Date September 9, 2002
First Posted Date September 11, 2002
Last Update Posted Date October 31, 2017
Study Start Date April 2001
Actual Primary Completion Date April 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00045773 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Treatment Outcome of Vascular Depression
Official Title Treatment Outcome of Vascular Depression
Brief Summary This 12-week study will evaluate the effectiveness of sertraline (Zoloft®) for treatment of depression associated with small vascular lesions in the brain (vascular depression).
Detailed Description

Major late life depression (LLD) is an important health problem with a large and growing number of affected individuals. A significant subset of patients with LLD, particularly those with vascular depression, have abnormalities in certain parts of the brain that are evident on MRI scans and may be associated with poor acute and long-term response to antidepressant treatment. Studies have also indicated that LLD patients frequently have frontal lobe dysfunction. A longitudinal study with the antidepressant nortriptyline has demonstrated that frontal lobe dysfunction is associated with poor acute response and a greater risk for recurrence of LLD. However, it is not known if this finding applies to other antidepressants. This study will be the first clinical trial to simultaneously test the effects of specific brain and psychological factors on course of response, remission rate, and other measures of health outcomes in people with LLD.

Participants are treated with sertraline for 12 weeks. During this period, participants undergo cognitive testing, MRI, electrocardiogram (EKG), and laboratory tests. Study visits occur every 2 weeks.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adults 60+ with major depression.
Condition
  • Depressive Disorder
  • Depression
Intervention Drug: Sertraline
50 - 200mg, once per day for 12 weeks.
Other Name: Zoloft
Study Groups/Cohorts 1
Intervention: Drug: Sertraline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 10, 2008)
208
Original Enrollment
 (submitted: June 23, 2005)
320
Actual Study Completion Date April 2006
Actual Primary Completion Date April 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Ages 60+
  2. DSM-IV criteria for MDD
  3. Hamilton Depression Rating Scale score >18
  4. No MRI contraindications, e.g. foreign metallic implants, pacemaker
  5. Medication free of any psychotropic drug except as otherwise noted for set washout period (see D.2.1)
  6. Mini Mental Status Exam score <21
  7. No unstable medical disorders (requiring immediate medical attention)
  8. Ability to give informed consent
  9. English speaking

Exclusion Criteria:

  1. Age <60
  2. Does not meet DSM-IV criteria for MDD
  3. Hamilton Depression Rating Scale score <18
  4. MRI contraindications e.g. foreign metallic implants, pacemaker
  5. Psychotropic drug use other than zolpidem and lorazepam, prn within 2 weeks of entry
  6. Mini Mental Status Exam score >21, or known primary neurological disorders including Dementia of the Alzheimer type, Parkinson's Disease, multiple sclerosis, seizure disorder.
  7. Unstable medical disorders, uncorrected hypothyroidism, or any condition that in the investigators opinion makes the patients unsuitable for a trial
  8. Cannot give informed consent
  9. Does not speak English
Sex/Gender
Sexes Eligible for Study: All
Ages 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00045773
Other Study ID Numbers R01MH060697( U.S. NIH Grant/Contract )
R01MH060697 ( U.S. NIH Grant/Contract )
DATR A4-GPX
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Yvette Sheline, University of Pennsylvania
Study Sponsor University of Pennsylvania
Collaborators
  • National Institute of Mental Health (NIMH)
  • Duke University
Investigators
Principal Investigator: Yvette I. Sheline, M.D. Washington University Psychiatrist
Principal Investigator: Murali Doraiswamy, M.D. Duke University
PRS Account University of Pennsylvania
Verification Date October 2017