Trial Outcomes & Findings for Combination Lexapro and Massage for Treatment of Depression in Older Adults (NCT NCT00643162)

Last Updated: 2019-06-18

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

17 participants

Primary outcome timeframe

9 weeks

Results posted on

2019-06-18

Participant Flow

4 subjects screen failed; 1 subject withdrew consent after screen. Total of 5 subjects were not randomized.

Participant milestones

Participant milestones
Measure	Swedish Massage Adding massage twice a week, for 8 weeks, and Lexapro in the treatment of depression. Lexapro: 5mg-10mg of lexapro, daily, for 9 weeks for all study participants. Massage: Massage twice a week, for 8 weeks.	Light-Touch Adding light touch twice a week, for 8 weeks, and Lexapro in the treatment of depression. Lexapro: 5mg-10mg of lexapro, daily, for 9 weeks for all study participants. Light touch: Light touch twice a week, for 8 weeks
Overall Study STARTED	7	5
Overall Study COMPLETED	6	4
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Swedish Massage Adding massage twice a week, for 8 weeks, and Lexapro in the treatment of depression. Lexapro: 5mg-10mg of lexapro, daily, for 9 weeks for all study participants. Massage: Massage twice a week, for 8 weeks.	Light-Touch Adding light touch twice a week, for 8 weeks, and Lexapro in the treatment of depression. Lexapro: 5mg-10mg of lexapro, daily, for 9 weeks for all study participants. Light touch: Light touch twice a week, for 8 weeks
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Combination Lexapro and Massage for Treatment of Depression in Older Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Swedish Massage n=7 Participants Adding massage twice a week, for 8 weeks, and Lexapro in the treatment of depression. Lexapro: 5mg-10mg of lexapro, daily, for 9 weeks for all study participants. Massage: Massage twice a week, for 8 weeks.	Light-Touch n=5 Participants Adding light touch twice a week, for 8 weeks, and Lexapro in the treatment of depression. Lexapro: 5mg-10mg of lexapro, daily, for 9 weeks for all study participants. Light touch: Light touch twice a week, for 8 weeks	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: 9 weeks

Population: A 7th Massage subject completed 6 of 7 visits so his data was carried forward to the final visit. Data from the LT subject who terminated early at Visit 3 was not used. An interim analysis was performed, there was one active subject still in the early stages of the protocol, whose data was not included. The interim analysis became final.

Outcome measures

Outcome measures
Measure	Swedish Massage n=7 Participants Adding massage twice a week, for 8 weeks, and Lexapro in the treatment of depression. Lexapro: 5mg-10mg of lexapro, daily, for 9 weeks for all study participants. Massage: Massage twice a week, for 8 weeks.	Light-Touch n=3 Participants Adding light touch twice a week, for 8 weeks, and Lexapro in the treatment of depression. Lexapro: 5mg-10mg of lexapro, daily, for 9 weeks for all study participants. Light touch: Light touch twice a week, for 8 weeks
Change in Hamilton Depression Scale (HAM-D) Score	13 units on a scale Standard Deviation 7.4	10.7 units on a scale Standard Deviation 4.9

SECONDARY outcome

Timeframe: 9 weeks

Population: Data was not abstracted since interim analysis recommended study closure

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.

Outcome measures

Outcome measures
Measure	Swedish Massage n=7 Participants Adding massage twice a week, for 8 weeks, and Lexapro in the treatment of depression. Lexapro: 5mg-10mg of lexapro, daily, for 9 weeks for all study participants. Massage: Massage twice a week, for 8 weeks.	Light-Touch n=3 Participants Adding light touch twice a week, for 8 weeks, and Lexapro in the treatment of depression. Lexapro: 5mg-10mg of lexapro, daily, for 9 weeks for all study participants. Light touch: Light touch twice a week, for 8 weeks
Change in Beck Depression Inventory Score	8.7 units on a scale Standard Deviation 6.6	6.3 units on a scale Standard Deviation 6.3

SECONDARY outcome

Timeframe: 9 weeks

Population: Data was not abstracted since interim analysis recommended study closure

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.

Outcome measures

Outcome measures
Measure	Swedish Massage n=7 Participants Adding massage twice a week, for 8 weeks, and Lexapro in the treatment of depression. Lexapro: 5mg-10mg of lexapro, daily, for 9 weeks for all study participants. Massage: Massage twice a week, for 8 weeks.	Light-Touch n=3 Participants Adding light touch twice a week, for 8 weeks, and Lexapro in the treatment of depression. Lexapro: 5mg-10mg of lexapro, daily, for 9 weeks for all study participants. Light touch: Light touch twice a week, for 8 weeks
Change in Hamilton Anxiety Scale (HAM-A) Score	5.3 units on a scale Standard Deviation 5.8	2.7 units on a scale Standard Deviation 13.1

Adverse Events

Swedish Massage

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Light-Touch

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Swedish Massage n=7 participants at risk Adding massage twice a week, for 8 weeks, and Lexapro in the treatment of depression. Lexapro: 5mg-10mg of lexapro, daily, for 9 weeks for all study participants. Massage: Massage twice a week, for 8 weeks.	Light-Touch n=5 participants at risk Adding light touch twice a week, for 8 weeks, and Lexapro in the treatment of depression. Lexapro: 5mg-10mg of lexapro, daily, for 9 weeks for all study participants. Light touch: Light touch twice a week, for 8 weeks
General disorders Cold Symptoms	14.3% 1/7 • Number of events 1 • 1 year	0.00% 0/5 • 1 year

Additional Information

Felicia Mayes

Cedars Sinai Medical Center

Phone: 310-423-0825

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place