Combination Lexapro and Massage for Treatment of Depression in Older Adults
NCT00643162 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17
Last updated 2019-06-18
Summary
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.
Conditions
Interventions
- DRUG
-
Lexapro
5mg-10mg of lexapro, daily, for 9 weeks for all study participants.
- BEHAVIORAL
-
Light touch
Light touch twice a week, for 8 weeks
- BEHAVIORAL
-
Massage
Massage twice a week, for 8 weeks.
Sponsors & Collaborators
-
Forest Laboratories
collaborator INDUSTRY -
Cedars-Sinai Medical Center
lead OTHER
Principal Investigators
-
Itai Danotivtch, Ph.D., M.D. · Cedars-Sinai Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-06-30
- Primary Completion
- 2010-02-28
- Completion
- 2010-02-28
Countries
- United States
Study Locations
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