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Trial record 81 of 585 for:    ESCITALOPRAM AND Celexa

Combination Lexapro and Massage for Treatment of Depression in Older Adults

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ClinicalTrials.gov Identifier: NCT00643162
Recruitment Status : Terminated (Interim analysis indicated recruitment was necessary beyond study capabilities.)
First Posted : March 26, 2008
Results First Posted : June 18, 2019
Last Update Posted : June 18, 2019
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Itai Danovitch, Cedars-Sinai Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Depression
Interventions Drug: Lexapro
Behavioral: Light touch
Behavioral: Massage
Enrollment 17
Recruitment Details  
Pre-assignment Details 4 subjects screen failed; 1 subject withdrew consent after screen. Total of 5 subjects were not randomized.
Arm/Group Title Swedish Massage Light-Touch
Hide Arm/Group Description

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.

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

Period Title: Overall Study
Started 7 5
Completed 6 4
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             1             1
Arm/Group Title Swedish Massage Light-Touch Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 7 5 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 5 participants 12 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  71.4%
3
  60.0%
8
  66.7%
>=65 years
2
  28.6%
2
  40.0%
4
  33.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 5 participants 12 participants
Female
3
  42.9%
5
 100.0%
8
  66.7%
Male
4
  57.1%
0
   0.0%
4
  33.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 5 participants 12 participants
Hispanic or Latino
1
  14.3%
0
   0.0%
1
   8.3%
Not Hispanic or Latino
6
  85.7%
5
 100.0%
11
  91.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 5 participants 12 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
  20.0%
1
   8.3%
White
6
  85.7%
4
  80.0%
10
  83.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
  14.3%
0
   0.0%
1
   8.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 7 participants 5 participants 12 participants
7 5 12
1.Primary Outcome
Title Change in Hamilton Depression Scale (HAM-D) Score
Hide Description 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.
Time Frame 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Swedish Massage Light-Touch
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 7 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
13  (7.4) 10.7  (4.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Swedish Massage, Light-Touch
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .68
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.3
Parameter Dispersion
Type: Standard Deviation
Value: 6.15
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Beck Depression Inventory Score
Hide Description 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.
Time Frame 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not abstracted since interim analysis recommended study closure
Arm/Group Title Swedish Massage Light-Touch
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 7 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.7  (6.6) 6.3  (6.3)
3.Secondary Outcome
Title Change in Hamilton Anxiety Scale (HAM-A) Score
Hide Description 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.
Time Frame 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not abstracted since interim analysis recommended study closure
Arm/Group Title Swedish Massage Light-Touch
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 7 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.3  (5.8) 2.7  (13.1)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Swedish Massage Light-Touch
Hide Arm/Group Description

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.

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

All-Cause Mortality
Swedish Massage Light-Touch
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)      0/5 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Swedish Massage Light-Touch
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      0/5 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Swedish Massage Light-Touch
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/7 (14.29%)      0/5 (0.00%)    
General disorders     
Cold Symptoms  [1]  1/7 (14.29%)  1 0/5 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
After 2 weeks of taking Lexapro, subject reported symptoms of coughing, sneezing, feeling feverish, fatigue and dizziness and attributed it to a lingering coldAlthough symptoms are not associated with Lexapro, Investigator wanted to report as an AE.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Felicia Mayes
Organization: Cedars Sinai Medical Center
Phone: 310-423-0825
Responsible Party: Itai Danovitch, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00643162     History of Changes
Other Study ID Numbers: 8648
First Submitted: March 20, 2008
First Posted: March 26, 2008
Results First Submitted: January 25, 2018
Results First Posted: June 18, 2019
Last Update Posted: June 18, 2019