Depression in Older Adults

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT00643162
First received: March 20, 2008
Last updated: March 26, 2012
Last verified: March 2012
  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

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Hamilton Depression Scale (HAM-D) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643162

Locations
United States, California
Cedars-Sinai Medical Center Department of Psychiatry and Behavioral Neurosciences
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Forest Laboratories
Investigators
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
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 15, 2014