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NCT00643162 · ClinicalTrials.gov registry record · NA
Combination Lexapro and Massage for Treatment of Depression in Older Adults
A NA study, sponsored by Cedars-Sinai Medical Center.
- Terminated
- Registry status
- NA
- Development phase
- 17
- Enrollment target
NCT00643162: Clinical Trial NA study, sponsored by Cedars-Sinai Medical Center.
NCT00643162 is a NA study that was terminated before completion, run by Cedars-Sinai Medical Center. The registered enrollment target is 17 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00643162, a NA study, was terminated before completion, sponsored by Cedars-Sinai Medical Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 17 participants
- Enrollment target
Study 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.
Primary Outcome
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 indica
Interventions
- DRUG Lexapro
- BEHAVIORAL Massage
- BEHAVIORAL Light touch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2006-06 |
| Est. Completion | 2010-02 |
| Phase | NA |
Why NCT00643162 stopped before completion
NCT00643162 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which Lexapro is the first listed.
NCT00643162 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00643162 about?
NCT00643162 is a clinical study titled "Combination Lexapro and Massage for Treatment of Depression in Older Adults". 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 sh...
What is the current status of trial NCT00643162?
This trial is currently terminated. It is a NA study. The enrollment target is 17 participants. The study started on 2006-06. Estimated completion is 2010-02.
What interventions are being tested in trial NCT00643162?
The interventions under investigation include: Lexapro (DRUG), Massage (BEHAVIORAL), Light touch (BEHAVIORAL).
Who is sponsoring clinical trial NCT00643162?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00643162's enrollment target sits among peer trials
17 1871st of 2000 higher than 130 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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