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Epidemiology of Depression, Anxiety, and Cognitive Impairment

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ClinicalTrials.gov Identifier: NCT00717041
Recruitment Status : Completed
First Posted : July 16, 2008
Results First Posted : June 15, 2015
Last Update Posted : June 15, 2015
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Manish Shah, University of Rochester

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Depression
Anxiety
Cognitive Impairment
Enrollment 1206
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Presenting to the ED
Hide Arm/Group Description Patients who present to the ED
Period Title: Overall Study
Started 1206
Completed 1206
Not Completed 0
Arm/Group Title Presenting to the ED
Hide Arm/Group Description Patients who present to the ED
Overall Number of Baseline Participants 1206
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 1206 participants
71
(65 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1206 participants
Female
634
  52.6%
Male
572
  47.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1206 participants
Hispanic or Latino
9
   0.7%
Not Hispanic or Latino
1184
  98.2%
Unknown or Not Reported
13
   1.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1206 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
178
  14.8%
White
1000
  82.9%
More than one race
0
   0.0%
Unknown or Not Reported
28
   2.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1206 participants
1206
Anxiety (>=10 on GAD7)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1206 participants
119
[1]
Measure Description: The number of participants with Generalized Anxiety Disorder - 7 scores greater than or equal to 10 (more anxiety).
Depression (>=10 on PHQ9)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1206 participants
177
[1]
Measure Description: Number of participants with the Patient Health Questionnaire - 9 (Depression) >= 10 (more depression).
Cognitive Impairment (>2 on SIS)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1206 participants
106
[1]
Measure Description: Number of participants with Six Item Screener testing with greater than 2 errors (more errors, worse cognition).
1.Primary Outcome
Title Participants With Depression by Patient Health Questionnaire - 9
Hide Description Number of participants with depression as measured by the Patient Health Questionnaire - 9, with a score of greater than or equal to 10.
Time Frame 2 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Presenting to the ED
Hide Arm/Group Description:
Patients who present to the ED
Overall Number of Participants Analyzed 1206
Measure Type: Number
Unit of Measure: participants
177
2.Primary Outcome
Title Participants With Cognitive Impairment by Six Item Screener
Hide Description Number of participants with cogintiive impairment as measured by the Six Item Screener, with greater than 2 questions incorrect
Time Frame 2 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Presenting to the ED
Hide Arm/Group Description:
Patients who present to the ED
Overall Number of Participants Analyzed 1206
Measure Type: Number
Unit of Measure: participants
106
3.Primary Outcome
Title Participants With Anxiety by Generalized Anxiety Disorder - 7
Hide Description Participants with anxiety as measured by the Generalized Anxiety Disorder - 7, with a score greater than or equal to 10.
Time Frame 2 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Presenting to the ED
Hide Arm/Group Description:
Patients who present to the ED
Overall Number of Participants Analyzed 1206
Measure Type: Number
Unit of Measure: participants
119
4.Secondary Outcome
Title Depression and Cognitive Impairment at 2 Weeks
Hide Description For the individuals who are able to be contacted in 2 weeks, how many still test positive for depression and cognitive impairment.
Time Frame 2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Depressed in the ED Cognitively Impaired in the ED
Hide Arm/Group Description:
Patients who present to the ED who test positive for depression
Patients presenting to the ED who have cognitive impairment
Overall Number of Participants Analyzed 803 808
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: participants
27
(19 to 38)
5
(4 to 25)
Time Frame While enrolled in the study, 2 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Presenting to the ED
Hide Arm/Group Description Patients who present to the ED
All-Cause Mortality
Presenting to the ED
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Presenting to the ED
Affected / at Risk (%)
Total   0/1206 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Presenting to the ED
Affected / at Risk (%)
Total   0/1206 (0.00%) 
  • Single center, limited generalizability
  • Large proportion of individuals lost to follow up
  • ED visit may have heightened symptoms
  • Validity of instruments in the ED setting is unknown
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Manish N. Shah, MD MPH
Organization: University of Rochester
Phone: 585-275-1198
Responsible Party: Manish Shah, University of Rochester
ClinicalTrials.gov Identifier: NCT00717041     History of Changes
Other Study ID Numbers: RSRB 24085
NIH 5K23AG028942
First Submitted: July 14, 2008
First Posted: July 16, 2008
Results First Submitted: May 22, 2015
Results First Posted: June 15, 2015
Last Update Posted: June 15, 2015