Depression in Older Adults
|ClinicalTrials.gov Identifier: NCT00643162|
Recruitment Status : Completed
First Posted : March 26, 2008
Last Update Posted : March 27, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Depression||Drug: Lexapro Behavioral: Light touch Behavioral: Massage||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Combination Lexapro and Massage for Treatment in Depression in Older Subjects|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||February 2010|
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
- Hamilton Depression Scale (HAM-D) [ Time Frame: 9 weeks ]
- Beck Depression Inventory [ Time Frame: 9 weeks ]
- Hamilton Anxiety Scale (HAM-A) [ Time Frame: 9 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|