Combination Lexapro and Massage for Treatment of Depression in Older Adults

NCT00643162 | Terminated Results

• 1 other identifier: 8648
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Depression; Massage; Lexapro; Alternative Therapy; Anti-depressant

Outcome Measures

Primary Outcomes (1)

• Change in Hamilton Depression Scale (HAM-D) Score

  The Hamilton Depression Rating Scale (HAM-D) is a clinician-administered tool used to determine a patient's level of depression before, during, and after treatment. The HAM-D form lists 21 items, but the scoring is based on the first 17 questions. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. The scores from each item are added together to provide a total score. The sum of the scores from the first 17 questions provides an indication for level of depression. 0-7 = normal, 8-13 = mild depression, 14-18 = moderate depression, 19-22=severe depression and ≥ 23=very severe depression.

  9 weeks

Secondary Outcomes (2)

• Change in Beck Depression Inventory Score

  9 weeks

• Change in Hamilton Anxiety Scale (HAM-A) Score

  9 weeks

Study Arms (2)

Swedish Massage

EXPERIMENTAL

Adding massage twice a week, for 8 weeks, and Lexapro in the treatment of depression.

Drug: Lexapro; Behavioral: Massage

Light-Touch

SHAM COMPARATOR

Adding light touch twice a week, for 8 weeks, and Lexapro in the treatment of depression.

Drug: Lexapro; Behavioral: Light touch

Interventions

Lexapro DRUG

5mg-10mg of lexapro, daily, for 9 weeks for all study participants.

Also known as: Escitalopram

Light-Touch; Swedish Massage

Light touch BEHAVIORAL

Light touch twice a week, for 8 weeks

Light-Touch

Massage BEHAVIORAL

Massage twice a week, for 8 weeks.

Swedish Massage

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• Forest Laboratories: collaborator

Study Sites (1)

Cedars-Sinai Medical Center Department of Psychiatry and Behavioral Neurosciences

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Escitalopram; Massage

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Results Point of Contact

• Title: Felicia Mayes
• Organization: Cedars Sinai Medical Center

mayesf@cshs.org

310-423-0825

Study Officials

• Itai Danotivtch, Ph.D., M.D.

  Cedars-Sinai Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Department of Psychiatry

Study Record Dates

• First Submitted: March 20, 2008
• First Posted: March 26, 2008
• Study Start: June 1, 2006
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: June 18, 2019
• Results First Posted: June 18, 2019

Record last verified: 2019-05

Locations

US (1)