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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Presenting to the ED Patients who present to the ED

Participant Flow:   Overall Study
    Presenting to the ED
STARTED   1206 
COMPLETED   1206 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Presenting to the ED Patients who present to the ED

Baseline Measures
   Presenting to the ED 
Overall Participants Analyzed 
[Units: Participants]
 1206 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 71 
 (65 to 80) 
Gender 
[Units: Participants]
 
Female   634 
Male   572 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   9 
Not Hispanic or Latino   1184 
Unknown or Not Reported   13 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   178 
White   1000 
More than one race   0 
Unknown or Not Reported   28 
Region of Enrollment 
[Units: Participants]
 
United States   1206 
Anxiety (>=10 on GAD7) [1] 
[Units: Participants]
 119 
[1] The number of participants with Generalized Anxiety Disorder - 7 scores greater than or equal to 10 (more anxiety).
Depression (>=10 on PHQ9) [1] 
[Units: Participants]
 177 
[1] Number of participants with the Patient Health Questionnaire - 9 (Depression) >= 10 (more depression).
Cognitive Impairment (>2 on SIS) [1] 
[Units: Participants]
 106 
[1] Number of participants with Six Item Screener testing with greater than 2 errors (more errors, worse cognition).


  Outcome Measures

1.  Primary:   Participants With Depression by Patient Health Questionnaire - 9   [ Time Frame: 2 hours ]

2.  Primary:   Participants With Cognitive Impairment by Six Item Screener   [ Time Frame: 2 hours ]

3.  Primary:   Participants With Anxiety by Generalized Anxiety Disorder - 7   [ Time Frame: 2 hours ]

4.  Secondary:   Depression and Cognitive Impairment at 2 Weeks   [ Time Frame: 2 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
  • 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


  More Information

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
e-mail: manish.shah@rochester.edu



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