Treatment Outcome of Vascular Depression
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| ClinicalTrials.gov Identifier: NCT00045773 |
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Recruitment Status :
Completed
First Posted : September 11, 2002
Last Update Posted : October 31, 2017
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| Condition or disease | Intervention/treatment |
|---|---|
| Depressive Disorder Depression | Drug: Sertraline |
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 |
| Actual Enrollment : | 208 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Treatment Outcome of Vascular Depression |
| Study Start Date : | April 2001 |
| Actual Primary Completion Date : | April 2006 |
| Actual Study Completion Date : | April 2006 |
| Group/Cohort | Intervention/treatment |
|---|---|
| 1 |
Drug: Sertraline
50 - 200mg, once per day for 12 weeks.
Other Name: Zoloft |
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| Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Ages 60+
- DSM-IV criteria for MDD
- Hamilton Depression Rating Scale score >18
- No MRI contraindications, e.g. foreign metallic implants, pacemaker
- Medication free of any psychotropic drug except as otherwise noted for set washout period (see D.2.1)
- Mini Mental Status Exam score <21
- No unstable medical disorders (requiring immediate medical attention)
- Ability to give informed consent
- English speaking
Exclusion Criteria:
- Age <60
- Does not meet DSM-IV criteria for MDD
- Hamilton Depression Rating Scale score <18
- MRI contraindications e.g. foreign metallic implants, pacemaker
- Psychotropic drug use other than zolpidem and lorazepam, prn within 2 weeks of entry
- Mini Mental Status Exam score >21, or known primary neurological disorders including Dementia of the Alzheimer type, Parkinson's Disease, multiple sclerosis, seizure disorder.
- Unstable medical disorders, uncorrected hypothyroidism, or any condition that in the investigators opinion makes the patients unsuitable for a trial
- Cannot give informed consent
- Does not speak English
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): NCT00045773
| United States, Missouri | |
| Washington University School of Medicine | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| Principal Investigator: | Yvette I. Sheline, M.D. | Washington University Psychiatrist | |
| Principal Investigator: | Murali Doraiswamy, M.D. | Duke University |
Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Yvette Sheline, Penn Faculty - McLure Professor, University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00045773 History of Changes |
| Other Study ID Numbers: |
R01MH060697 ( U.S. NIH Grant/Contract ) R01MH060697 ( U.S. NIH Grant/Contract ) DATR A4-GPX |
| First Posted: | September 11, 2002 Key Record Dates |
| Last Update Posted: | October 31, 2017 |
| Last Verified: | October 2017 |
Additional relevant MeSH terms:
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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 |