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,

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:

If you would like to learn more about participating in this study, please send an e-mail message using the form below.

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Trial listings updated: June 1, 2008 at 6:32:53 AM


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