Clinical trial NCT00643162: Combination Lexapro and Massage for Treatment of Depression in Older Adults
Official title: Combination Lexapro and Massage for Treatment in Depression in Older Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depression
Keywords: Depression
Massage
Lexapro
Alternative Therapy
Anti-depressant
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2008-03-26
Enrollment: 17
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 who meet inclusion/exclusion criteria will receive escitalopram and also be randomized 1:1 (by computer) to Swedish massage or light touch. Escitalopram (5.0 mg/day, PO) will initially be administered for one week followed by an increase in dose to 10 mg/day for the remainder of the study; Massage or touch will be performed twice per week for 8 weeks. Every effort will be made to have non-consecutive massage/touch visits. The massage group will receive Swedish massage for 50 minutes twice per week. In the "touch" group, the massage therapist will provide gentle touch to the skin in the same distribution as that of the formal Swedish massage for 50 minutes twice per week. Every effort will be made to have one therapist perform all treatments. All assessments will be obtained prior to the first massage each week.
2. Recruitment and Retention: Subjects will be recruited from our outpatient clinic, attendings, as well as by advertising on radio, television, newspaper and our web site.
3. Treatment

   1. Massage: Standard Swedish massage therapy will be employed which includes the systematic manipulation of the soft tissues of the body. It is designed to relax muscles by applying pressure to them against deeper muscles and bones, and rubbing in the same direction as the flow of blood returning to the heart. A routine has been designed whereby the therapist massages different areas of the body in an orderly fashion for specified periods of time. For sham massage (light touch), the massage therapists will provide gentle touch to the skin in the same distribution and duration as that of the formal Swedish massage. As mentioned below, deviations from the structured massage or touch will be recorded in the massage therapist's diary.
   2. Quality control for screening and outcome questionnaires: Kappa co-efficients for diagnostic and inter-rater reliability will be determined at six-month intervals. We routinely maintain kappa values of at \>0.85.
4. Outcome Measures: Primary outcome measure for this study will be degree of depression as measured by HAM-D. The secondary outcome measures will include quality of life, HAM-A, Beck Depression Inventory. Raters will be blind to treatment cell and test results.

   Quality control for screening and outcome questionnaires: Kappa co-efficients for diagnostic and inter-rater reliability will be determined at six-month intervals. We routinely maintain kappa values of at \>0.85.
5. Statistical Analysis All entries will be blind-verified, and following data entry, results will be checked for obvious outliers and inconsistent values. No single person will have the responsibility for both entry and verification on a given form. Data on computer records will be identifiable by a unique coded identifier to permit matching of records longitudinally. Each record will be logged as it is obtained. An archival record of all data collected, which has passed the above-noted checks, will be maintained on a hard disk. A backup of the archival data will be saved on magnetic tape (DAT tape) and writable CD-ROM archive disks. This copy will be stored in a separate offsite cabinet to ensure the survival of data in case of a natural disaster. A full backup will be made weekly, and stored for at least three months. A CD-ROM backup will be made every three months.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Hamilton Depression Scale (HAM-D) Score
timeFrame: 9 weeks
Secondary outcomes:
measure: Change in Beck Depression Inventory Score
timeFrame: 9 weeks
measure: Change in Hamilton Anxiety Scale (HAM-A) Score
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center Department of Psychiatry and Behavioral Neurosciences
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Itai Danotivtch, Ph.D., M.D.
role: STUDY_CHAIR
References: