Trial Outcomes & Findings for Epidemiology of Depression, Anxiety, and Cognitive Impairment (NCT NCT00717041)

NCT ID: NCT00717041

Last Updated: 2015-06-15

Results Overview

Number of participants with depression as measured by the Patient Health Questionnaire - 9, with a score of greater than or equal to 10.

• Recruitment status: COMPLETED
• Target enrollment: 1206 participants
• Primary outcome timeframe: 2 hours
• Results posted on: 2015-06-15

Participant Flow

Participant milestones

Measure	Presenting to the ED Patients who present to the ED
Overall Study STARTED	1206
Overall Study COMPLETED	1206
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Epidemiology of Depression, Anxiety, and Cognitive Impairment

Baseline characteristics by cohort

Measure	Presenting to the ED n=1206 Participants Patients who present to the ED
Age, Continuous	71 years n=5 Participants
Sex: Female, Male Female	634 Participants n=5 Participants
Sex: Female, Male Male	572 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1184 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	178 Participants n=5 Participants
Race (NIH/OMB) White	1000 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	28 Participants n=5 Participants
Region of Enrollment United States	1206 participants n=5 Participants
Anxiety (>=10 on GAD7)	119 participants n=5 Participants
Depression (>=10 on PHQ9)	177 participants n=5 Participants
Cognitive Impairment (>2 on SIS)	106 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 hours

Number of participants with depression as measured by the Patient Health Questionnaire - 9, with a score of greater than or equal to 10.

Outcome measures

Measure	Presenting to the ED n=1206 Participants Patients who present to the ED	Cognitively Impaired in the ED Patients presenting to the ED who have cognitive impairment
Participants With Depression by Patient Health Questionnaire - 9	177 participants	—

PRIMARY outcome

Timeframe: 2 hours

Number of participants with cogintiive impairment as measured by the Six Item Screener, with greater than 2 questions incorrect

Outcome measures

Measure	Presenting to the ED n=1206 Participants Patients who present to the ED	Cognitively Impaired in the ED Patients presenting to the ED who have cognitive impairment
Participants With Cognitive Impairment by Six Item Screener	106 participants	—

PRIMARY outcome

Timeframe: 2 hours

Participants with anxiety as measured by the Generalized Anxiety Disorder - 7, with a score greater than or equal to 10.

Outcome measures

Measure	Presenting to the ED n=1206 Participants Patients who present to the ED	Cognitively Impaired in the ED Patients presenting to the ED who have cognitive impairment
Participants With Anxiety by Generalized Anxiety Disorder - 7	119 participants	—

SECONDARY outcome

Timeframe: 2 weeks

For the individuals who are able to be contacted in 2 weeks, how many still test positive for depression and cognitive impairment.

Outcome measures

Measure	Presenting to the ED n=803 Participants Patients who present to the ED	Cognitively Impaired in the ED n=808 Participants Patients presenting to the ED who have cognitive impairment
Depression and Cognitive Impairment at 2 Weeks	27 participants Interval 19.0 to 38.0	5 participants Interval 4.0 to 25.0

Adverse Events

Presenting to the ED

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Manish N. Shah, MD MPH

University of Rochester

Phone: 585-275-1198

Email: manish.shah@rochester.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place