Depression in Older Adults
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Depression |
Drug: Lexapro Behavioral: Light touch Behavioral: Massage |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Combination Lexapro and Massage for Treatment in Depression in Older Subjects |
- Hamilton Depression Scale (HAM-D) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
- Beck Depression Inventory [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
- Hamilton Anxiety Scale (HAM-A) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 17 |
| Study Start Date: | June 2006 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Swedish Massage
Adding massage twice a week, for 8 weeks, and Lexapro in the treatment of depression.
|
Drug: Lexapro
5mg-10mg of lexapro, daily, for 9 weeks for all study participants.
Behavioral: Massage
Massage twice a week, for 8 weeks.
|
|
Sham Comparator: Light-Touch
Adding light touch twice a week, for 8 weeks, and Lexapro in the treatment of depression.
|
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
|
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- > 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 Criteria:
- 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
Contacts and Locations| United States, California | |
| Cedars-Sinai Medical Center Department of Psychiatry and Behavioral Neurosciences | |
| Los Angeles, California, United States, 90048 | |
| Principal Investigator: | Robert Cohen, Ph.D., M.D. | Cedars-Sinai Medical Center |
More Information
No publications provided
| Responsible Party: | Dr. Robert Cohen, Cedars-Sinai Medical Center Department of Psychiatry and Behavioral Neurosciences |
| ClinicalTrials.gov Identifier: | NCT00643162 History of Changes |
| Other Study ID Numbers: | 8648, 00008648 |
| Study First Received: | March 20, 2008 |
| Last Updated: | March 26, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Cedars-Sinai Medical Center:
|
Depression Massage Lexapro Alternative Therapy Anti-depressant |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders Dexetimide Citalopram Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Parasympatholytics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Serotonin Agents |
ClinicalTrials.gov processed this record on May 19, 2013