DepressionNCT00643162
Combination Lexapro and Massage for Treatment of Depression in Older Adults
A study testing Lexapro, Light touch and Massage in people with Depression, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Lexapro, Light touch and Massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Feb 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center Department of Psychiatry and Behavioral Neurosciences
Los Angeles, California, 90048
About this study
Official title: Combination Lexapro and Massage for Treatment in Depression in Older Subjects
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.
Read the detailed description
- 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.
- 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.
- Treatment
- 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.
- 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.
- 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.
- 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.
- Conditions
- Depression
- Being tested
- Lexapro, Light touch, Massage
- Keywords
- Depression, Massage, Lexapro, Alternative Therapy, Anti-depressant
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LexaproDrug
Also called Escitalopram
5mg-10mg of lexapro, daily, for 9 weeks for all study participants.
Light touchBehavioural
Light touch twice a week, for 8 weeks
MassageBehavioural
Massage twice a week, for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Swedish Massage | Experimental | Adding massage twice a week, for 8 weeks, and Lexapro in the treatment of depression. Receives: Drug: Lexapro; Behavioral: Massage |
| Light-Touch | Sham comparator | Adding light touch twice a week, for 8 weeks, and Lexapro in the treatment of depression. Receives: Drug: Lexapro; Behavioral: Light touch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 weeks
Secondary outcomes (2)
Change in Beck Depression Inventory Score
The Beck Depression Inventory (BDI) is a series of 21-question, self-report rating inventory developed at a 5th grade reading level that measures characteristic attitudes and symptoms of depression. It was develop to detect, assess and monitor changes in depressive symptoms. For people who have been clinically diagnosed with depression, scores from 0 to 9 represent minimal depressive symptoms, scores of 10 to 16 indicate mild depression, scores of 17 to 29 indicate moderate depression, and scores of 30 to 63 indicate severe depression.
Measured: 9 weeks
Change in Hamilton Anxiety Scale (HAM-A) Score
The Hamilton Depression Rating Scale (HAM-D) is a clinician-administered tool used to determine a patient's level of anxiety before, during, and after treatment. The HAM-A is a 14-item assessment and each item is scored on a 5-point scale, ranging from 0 = not present to 4 = very severe. The sum of the scores is: 0-17 = mild anxiety, 18-24 = moderate anxiety, 25-30 = severe anxiety, and >30 = very severe anxiety.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startJun 2006
- Primary completionFeb 2010
- Study completionFeb 2010
Why it stopped: Interim analysis indicated recruitment was necessary beyond study capabilities.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Responsible party
- Principal investigator, Itai Danovitch, Cedars-Sinai Medical Center
- Investigators
- Itai Danotivtch, Ph.D., M.D., Study chair, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643162
- Sponsor's protocol ID
- 8648
- Status last verified
- May 2019
- First submitted
- 20 Mar 2008
- Last updated
- 18 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Lexapro and Massage for Treatment in Depression in Older Subjects
- ClinicalTrials.gov ID
- NCT00643162
- Acronym / sponsor ID
- 8648
- Conditions
- Depression
- Keywords
- Depression, Massage, Lexapro, Alternative Therapy, Anti-depressant
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis indicated recruitment was necessary beyond study capabilities.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Jun 2006
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 26 Mar 2008 (estimated)
- Results
- Posted 18 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- Treatment
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Swedish Massage | Experimental | Drug: Lexapro, Behavioral: MassageAdding massage twice a week, for 8 weeks, and Lexapro in the treatment of depression. |
| Light-Touch | Sham comparator | Drug: Lexapro, Behavioral: Light touchAdding light touch twice a week, for 8 weeks, and Lexapro in the treatment of depression. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- > 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LexaproAlso: Escitalopram5mg-10mg of lexapro, daily, for 9 weeks for all study participants. | Drug | Light-Touch, Swedish Massage |
| Light touchLight touch twice a week, for 8 weeks | Behavioural | Light-Touch |
| MassageMassage twice a week, for 8 weeks. | Behavioural | Swedish Massage |
Primary outcome
Change in Hamilton Depression Scale (HAM-D) Score
Time frame: 9 weeks
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.
2 secondary outcomes
Change in Beck Depression Inventory Score
Time frame: 9 weeks
Change in Hamilton Anxiety Scale (HAM-A) Score
Time frame: 9 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Itai Danotivtch, Ph.D., M.D. study chair
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lexapro, Light touch and Massage in people with Depression, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hamilton Depression Scale (HAM-D) Score (time frame: 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2019.