Official Title: “Combination Lexapro and Massage for Treatment in Depression in Older Subjects”

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 Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Study Primary Completion Date: June 2010

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Adding massage twice a week, for 8 weeks, and Lexapro in the treatment of depression.
• Placebo Comparator: 2
  • Adding light touch twice a week, for 8 weeks, and Lexapro in the treatment of depression.

Primary Measures

• Hamilton Depression Scale (HAM-D)
  • Time Frame: 9 weeks
    Safety Issue?: No

Secondary Measures

• Beck Depression Inventory
  • Time Frame: 9 weeks
    Safety Issue?: No
• Hamilton Anxiety Scale (HAM-A)
  • Time Frame: 9 weeks
    Safety Issue?: No

Inclusion Criteria:

• 1. > 60 years of age
• 2. Unipolar major depression as defined by Structured Clinical Interaction DSM-IV (SCID)
• 3. HAM-D score of > 17 (21-item scale)]]
• 4. Not taking antidepressants for at least two weeks, 2 months for fluoxetine and MAOIs]]
• 5. Capable of giving informed consent.

Exclusion Criteria:

• 1. Unable to provide informed consent (e.g. severe cognitive impairment)
• 2. Acute medical condition or exacerbation of chronic medical condition associated with significant distress (pain, protracted fevers, etc.) and requiring active medical treatment.
• 3. High risk of suicide or violence as assessed by the investigator
• 4. Current or past history of psychosis or bipolar disorder
• 5. Use of psychotropic medication and/or psychotherapy outside of the study
• 6. (Exposure to treatment of fluoxetine or MAOIs in the previous two months; chronic use of benzodiazepine and non-benzodiazepine sedatives, antipsychotics, psychostimulants, mood stabilizing agents, codeine, steroids, anti-inflammatory agents.
• 7. Alternative medicine use in the preceding 30 days (e.g. acupuncture, herbs, etc.)
• 8. History of intolerance to massage or contraindication to massage (e.g. skin lesions that prevent direct contact by the therapist)
• 9. Diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, schizotypal disorder, psychotic depression or bipolar disorders;
• 10. MMSE less than 22
• 11. Alzheimer's Disease Assessment Scale-Cognitive Subscale ³ greater than 12
• 12. Current drug or alcohol abuse or dependence or history of drug or alcohol abuse or dependence within the past 6 months
• 13. Unstable medical or neurological conditions that are likely to interfere with the treatment of depression
• 14. Currently on psychotropic medications including antidepressants or neuroleptics
• 15. Active suicidal ideation or other safety issues determined by the clinician to not be suitable for inclusion in the study

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 60 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Cedars-Sinai Medical Center

Overall Clinical Trial Officials and Contacts

Robert Cohen, Ph.D., M.D. Principal Investigator Cedars-Sinai Medical Center  

Overall Contact: Anna Davis, N.P. 310.423.6515 psychiatryresearch@cshs.org

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00643162

Study ID Number: 8648

ClinicalTrials.gov Identifier: NCT00643162

Health Authority: United States: Institutional Review Board

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