Trial Information
Summary: Combination Lexapro and massage for treatment of depression in elderly subjects
Depression is a major public health problem, particularly in the
elderly population. Although parmacotherapy is the most common
treatment for depression, it is not optimal, especially for elderly
patients. To compensate for incomplete response to antidepressants,
many combined and augmentation strategies have been used, including
massage.
The purpose of this research study is to investigate the effects
of massage therapy on symptoms of depression in elderly subjects
with major depression. All subjects will receive escitalopramm
(Lexapro), an FDA-approved anti-depressant. Subjects will be
randomized into one of two possible study groups. One group will
receive Swedish massage for 50 minutes, 2 times a week for 8 weeks.
The other group will receive light touch for 50 minutes, 2 times a
week for 8 weeks.
The study will last for a total of 10 weeks including a 3-hour
initial study visit, a baseline study visit, and then 2 weekly
study visits for 8 weeks. A study doctor will monitor all subjects
throughout research study.
Subjects will not incur a charge for study medication and
treatments.
Patient Inclusion Criteria:
- Subject greater than 60 years of age
- Subject must be suffering from symptoms of depression as
evaluated by study staff
- Subject has not taken antidepressants for at least two weeks (2
months for fluoxetine and MAOIs)
Patient Exclusion Criteria:
- Subject has acute medical condition or exacerbation of chronic
medical condition associated with significant distress (pain,
protracted fevers, etc.) and requiring active medical
treatment
- Subject is at high risk for suicide or violence as assessed by
investigator
- Subject has current or past history of psychosis or bipolar
disorder
- Subject currently uses psychotropic medication and/or
psychotherapy outside of the study
- Exposure to treatment of fluoxine or MAOIs within two months
prior to study entry
- Chronic use of benzodiazepine and non-benzodiazepine sedatives,
antipsychotics, psychostimulants, mood stabilizing agents, codeine,
steroids, anti-inflammatory agents
- Subject has used alternative medicine (e.g. acupuncture, herbs)
in the preceding 30 days
- Subject has history of intolerance to massage or
contraindication to massage (e.g. skin lesions that prevent direct
contact)
- Diagnosis of schizophrenia, schizophreniform disorder,
schizoaffective disorder, psychotic depression or bipolar
disorders
- Subject has current drug or alcohol abuse or dependence or
history of drug or alcohol abuse or dependence within last 6
months
- Subject currently has unstable medical or neurological
conditions that are likely to interfere with the treatment of
depression
For more information,
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Contact:
Lisa Glassman, Study Coordinator
Cedars-Sinai Medical Center
8730 Alden Dr. Room E123
Los Angeles, CA 90048
Telephone: 310-423-6515
Fax: 310-423-0888
Email:
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Trial listings updated: June 1, 2008 at 6:32:53 AM