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Treatment Response of Geriatric Depression (ERP)

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ClinicalTrials.gov Identifier: NCT00754936
Recruitment Status : Completed
First Posted : September 18, 2008
Results First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Forest Laboratories
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Depression
Intervention Drug: Escitalopram
Enrollment 106
Recruitment Details Overall flow of study participants
Pre-assignment Details 106 participants enrolled in the study; however, 35 exited during the 2-week washout period and did not start study medication.
Arm/Group Title Escitalopram
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12 week open label with 2 week placebo period (14 weeks total)

Escitalopram: 20 mg by mouth daily

Period Title: Overall Study
Started 71
Completed 59
Not Completed 12
Reason Not Completed
Lost to Follow-up             3
Physician Decision             1
Withdrawal by Subject             2
Side Effects             3
Inter-current medical events             3
Arm/Group Title Escitalopram
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12 week open label with 2 week placebo period (14 weeks total)

Escitalopram: 20 mg by mouth daily

Overall Number of Baseline Participants 71
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants
<=18 years
0
   0.0%
Between 18 and 65 years
13
  18.3%
>=65 years
58
  81.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 71 participants
71.91  (7.53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants
Female
36
  50.7%
Male
35
  49.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants
Hispanic or Latino
4
   5.6%
Not Hispanic or Latino
67
  94.4%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   1.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
   5.6%
White
66
  93.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 71 participants
71
Hamilton Depression Rating Scale (HDRS) 24-Item Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 71 participants
23.83  (4.48)
[1]
Measure Description: HDRS 24 item: scores can range from 0-76; higher is worse(more depressed)
Montgomery and Asberg Depression Rating Scale (MADRS) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 71 participants
24.08  (5.74)
[1]
Measure Description: MADRS: scores can range from 0-60; higher is worse(more depressed)
1.Primary Outcome
Title Montgomery Asberg Depression Rating Scale (Depression Severity)
Hide Description A published and widely used scale for measuring severity of depression. Montgomery Asberg Depression Rating Scale scores can range from 0-60. Higher scores indicate greater severity of depression. Total scores are reported with no subscales.
Time Frame 14 weeks from enrollment (12 weeks from medication start)
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram
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12 week open label with 2 week placebo period (14 weeks total)

Escitalopram: 20 mg by mouth daily

Overall Number of Participants Analyzed 71
Mean (Standard Deviation)
Unit of Measure: units on a scale
12.23  (7.67)
2.Secondary Outcome
Title Hamilton Depression Rating Scale (Depression Severity)
Hide Description A published and widely-used scale for rating depression severity, the Hamilton Depression Rating Scale 24 item total scores range from 0-76. Higher scores indicate greater severity of depression. Total scores are reported with no subscales.
Time Frame 14 weeks from enrollment (12 weeks from medication start)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram
Hide Arm/Group Description:

12 week open label with 2 week placebo period (14 weeks total)

Escitalopram: 20 mg by mouth daily

Overall Number of Participants Analyzed 71
Mean (Standard Deviation)
Unit of Measure: units on a scale
11.47  (6.64)
Time Frame 14 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Escitalopram
Hide Arm/Group Description

12 week open label with 2 week placebo period (14 weeks total)

Escitalopram: 20 mg by mouth daily

All-Cause Mortality
Escitalopram
Affected / at Risk (%)
Total   0/71 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Escitalopram
Affected / at Risk (%) # Events
Total   3/71 (4.23%)    
Surgical and medical procedures   
Hospitalisation  1  3/71 (4.23%)  3
1
Term from vocabulary, MedDRA (21.1)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Escitalopram
Affected / at Risk (%) # Events
Total   47/71 (66.20%)    
Endocrine disorders   
Hyperparathyroidism  1  1/71 (1.41%)  1
Gastrointestinal disorders   
Abdominal pain upper  1  1/71 (1.41%)  1
Colitis ulcerative  1  1/71 (1.41%)  1
Diarrhoea  1  12/71 (16.90%)  15
Dry mouth  1  1/71 (1.41%)  1
Nausea  1  2/71 (2.82%)  2
Upper gastrointestinal haemorrhage  1  1/71 (1.41%)  1
Vomiting  1  1/71 (1.41%)  1
Infections and infestations   
Conjunctivitis  1  1/71 (1.41%)  1
Gastroenteritis  1  1/71 (1.41%)  1
Gastroenteritis viral  1  1/71 (1.41%)  1
Groin infection  1  1/71 (1.41%)  1
Sinusitis  1  2/71 (2.82%)  2
Upper respiratory tract infection  1  2/71 (2.82%)  2
Urinary tract infection  1  1/71 (1.41%)  1
Injury, poisoning and procedural complications   
Fall  1  21/71 (29.58%)  38
Fracture  1  1/71 (1.41%)  1
Investigations   
Colonoscopy  1  1/71 (1.41%)  1
Weight decreased  1  1/71 (1.41%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/71 (1.41%)  1
Polymyalgia rheumatica  1  1/71 (1.41%)  1
Nervous system disorders   
Burning sensation  1  2/71 (2.82%)  3
Cerebrovascular accident  1  1/71 (1.41%)  1
Dizziness  1  3/71 (4.23%)  3
Sinus headache  1  1/71 (1.41%)  1
Psychiatric disorders   
Anxiety  1  1/71 (1.41%)  1
Renal and urinary disorders   
Micturition urgency  1  1/71 (1.41%)  1
Pollakiuria  1  1/71 (1.41%)  1
Respiratory, thoracic and mediastinal disorders   
Epistaxis  1  1/71 (1.41%)  1
Skin and subcutaneous tissue disorders   
Night Sweats  1  1/71 (1.41%)  1
Rash  1  2/71 (2.82%)  2
Skin irritation  1  1/71 (1.41%)  1
Surgical and medical procedures   
Surgery  1  1/71 (1.41%)  1
1
Term from vocabulary, MedDRA (21.1)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: George S Alexopoulos
Organization: Weill Cornell Medicine
Phone: 914-997-5767
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00754936     History of Changes
Other Study ID Numbers: 0703009061
R01MH079414-01A1 ( U.S. NIH Grant/Contract )
First Submitted: September 17, 2008
First Posted: September 18, 2008
Results First Submitted: February 25, 2019
Results First Posted: March 19, 2019
Last Update Posted: March 19, 2019