Depression in Older Adults
Depression is a common and disabling condition which represents a substantial public health concern, especially with the aging of the population in general. In fact, one to four percent of the older population has major depression. Although medication is the main treatment for depression, studies show that only 50% of patients show a significant response to treatment. The response might actually be less in older subjects, and with more adverse side effects due to changes in the metabolism of the older population as well as drug interaction. For these reasons (changes in metabolism and possible drug interactions) the starting dose of the antidepressant Lexapro will be 5mg, instead of 10mg.
To combat the incomplete response to medication, many combined and augmentation strategies have been developed. Examples of this would be an antidepressant medication plus a neuroleptic medication; or an antidepressant medication plus talk therapy. One non-medication treatment that is being considered is massage therapy. Recent data suggest that massage therapy can be useful for the treatment of depression.
This study proposes to perform a controlled trail to assess the effects of massage therapy on symptoms of depression in older subjects with major depression. All of the subjects will receive Lexapro, which is an FDA approved medication for the treatment of depression. Half of the subjects will receive Swedish massage for one hour, twice a week, and the other half will receive light touch for one hour, twice per week for eight weeks. Standardized rating scales that evaluate depression will be used to evaluate the subjects mood.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Combination Lexapro and Massage for Treatment in Depression in Older Subjects|
- Hamilton Depression Scale (HAM-D) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
- Beck Depression Inventory [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
- Hamilton Anxiety Scale (HAM-A) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||June 2006|
|Study Completion Date:||February 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Experimental: Swedish Massage
Adding massage twice a week, for 8 weeks, and Lexapro in the treatment of depression.
5mg-10mg of lexapro, daily, for 9 weeks for all study participants.Behavioral: Massage
Massage twice a week, for 8 weeks.
Sham Comparator: Light-Touch
Adding light touch twice a week, for 8 weeks, and Lexapro in the treatment of depression.
5mg-10mg of lexapro, daily, for 9 weeks for all study participants.Behavioral: Light touch
Light touch twice a week, for 8 weeks
Please refer to this study by its ClinicalTrials.gov identifier: NCT00643162
|United States, California|
|Cedars-Sinai Medical Center Department of Psychiatry and Behavioral Neurosciences|
|Los Angeles, California, United States, 90048|
|Principal Investigator:||Robert Cohen, Ph.D., M.D.||Cedars-Sinai Medical Center|