Status:
TERMINATED
Combination Lexapro and Massage for Treatment of Depression in Older Adults
Lead Sponsor:
Cedars-Sinai Medical Center
Collaborating Sponsors:
Forest Laboratories
Conditions:
Depression
Eligibility:
All Genders
60+ years
Phase:
NA
Brief 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 p...
Detailed Description
1. Study Design: This will be an open-label, randomized control trial of concomitant massage therapy and escitalopram pharmacotherapy for the treatment of major depression in the elderly. All subjects...
Eligibility Criteria
Inclusion
- \> 60 years of age
- Unipolar major depression as defined by Structured Clinical Interaction DSM-IV (SCID)
- HAM-D score of \> 17 (21-item scale)\]\]
- Not taking antidepressants for at least two weeks, 2 months for fluoxetine and MAOIs\]\]
- Capable of giving informed consent.
Exclusion
- Unable to provide informed consent (e.g. severe cognitive impairment)
- Acute medical condition or exacerbation of chronic medical condition associated with significant distress (pain, protracted fevers, etc.) and requiring active medical treatment.
- High risk of suicide or violence as assessed by the investigator
- Current or past history of psychosis or bipolar disorder
- Use of psychotropic medication and/or psychotherapy outside of the study
- (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.
- Alternative medicine use in the preceding 30 days (e.g. acupuncture, herbs, etc.)
- History of intolerance to massage or contraindication to massage (e.g. skin lesions that prevent direct contact by the therapist)
- Diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, schizotypal disorder, psychotic depression or bipolar disorders;
- MMSE less than 22
- Alzheimer's Disease Assessment Scale-Cognitive Subscale ³ greater than 12
- Current drug or alcohol abuse or dependence or history of drug or alcohol abuse or dependence within the past 6 months
- Unstable medical or neurological conditions that are likely to interfere with the treatment of depression
- Currently on psychotropic medications including antidepressants or neuroleptics
- Active suicidal ideation or other safety issues determined by the clinician to not be suitable for inclusion in the study
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00643162
Start Date
June 1 2006
End Date
February 1 2010
Last Update
June 18 2019
Active Locations (1)
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1
Cedars-Sinai Medical Center Department of Psychiatry and Behavioral Neurosciences
Los Angeles, California, United States, 90048