Status:
COMPLETED
Exercise Training Versus Drug Therapy for Treating Depression in Older Adults
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Depression
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
This study will evaluate the effectiveness of both center-based and home-based exercise versus the antidepressant drug sertraline in treating depression in middle-aged and older adults.
Detailed Description
The combination of an aging population and the increased prevalence of chronic diseases among the elderly presents a major public health concern. Depression acts as both a cause and a consequence of d...
Eligibility Criteria
Inclusion
- DSM-IV diagnosis of major depressive disorder (MDD)
- Score of greater than 11 on the Beck Depression Inventory (BDI)
Exclusion
- Primary psychiatric diagnosis other than major depressive disorder (e.g., bipolar disorder)
- Any of the following DSM-IV diagnoses: dementia or delirium; obsessive compulsive disorder (OCD); schizophrenia, schizoaffective, or other psychotic disorder; psychotic features, including any delusions or hallucinations during the current depressive episode; current alcohol or other substance abuse disorder; acute risk for suicide (e.g., score of greater than 2 on the suicide item on the HAM-D) or acute risk for homicide
- May require treatment with additional psychotherapeutic agents (other than chloral hydrate for sleep) during the course of the study
- Significant medical conditions that may cause an increased risk for a significant adverse experience during the course of the trial (e.g., unstable angina, myocardial infarction within 3 months of study entry, etc.)
- Unable to be randomly assigned to the study drug due to a risk for adverse cardiac events, such as prolonged QT interval, use of other medications that would be counterindicated for use with sertraline, or other conditions that may make study participation unsafe
- Unable to be randomly assigned to an exercise condition due to medical conditions such as musculoskeletal problems or abnormal cardiac response to exercise (e.g., exercise-induced ventricular tachycardia, abnormal blood pressure response, etc.)
- Currently receiving antidepressant medication or actively engaged in psychotherapy
- Currently exercising regularly
Key Trial Info
Start Date :
August 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
457 Patients enrolled
Trial Details
Trial ID
NCT00331305
Start Date
August 1 1999
End Date
May 1 2007
Last Update
August 29 2013
Active Locations (1)
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1
Duke University Medical Center, Department of Psychiatry and Behavioral Sciences
Durham, North Carolina, United States, 27710