REMIT: Responses of Myocardial Ischemia to Escitalopram Treatment

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00574847
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 127
• Location: 1
• Arms: 2
• Duration (Months): 62
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

Depression is commonly seen in patients with cardiovascular disorders. In recent studies it has been shown that mild to moderate depression symptoms were associated with increased likelihood of mental stress-induced myocardial ischemia (MSIMI), which is a risk factor of poor cardiac outcome. In this project, the investigators aim to assess the treatment of mental stress-induced myocardial ischemia in ischemic heart disease patients with mild to moderate depressive symptoms. This study is a six-week double-blind placebo controlled study to examine the effects of escitalopram on mental stress-induced myocardial ischemia. This study will look to show that patients with ischemic heart disease who are treated with escitalopram will exhibit a significant improvement of MSIMI at the end of week 6 compared to patients receiving placebo.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Ischemia	Drug: Escitalopram; Drug: Placebo	Phase 4

Detailed Description

The goals of this project are to investigate the response of mental stress-induced myocardial ischemia (MSIMI) to escitalopram, a selective serotonin reuptake inhibitor (SSRI); to determine whether MSIMI will be reduced by the treatment, and whether the modification of MSIMI is related to improvement of depression symptoms, and/or the reduction of platelet aggregation, and/or the reduction of cardiovascular reactivity. This is a randomized study using escitalopram versus placebo for stable ischemic heart disease patients with MSIMI. This study will also explore the role of platelet activity in occurrence with MSIMI and other characteristics of MSIMI, such as systolic and diastolic function of the left ventricle during mental stress testing as compared to exercise testing.

The stress testing will be conducted at the Duke Cardiology Diagnostic Unit Laboratory. Following a 20-minute calibration-rest period, participants will be asked to complete a series of 3 mental stress tasks. There are 3 mental stress tasks to be used for this study, i.e., (1) Mental arithmetic: during this test, patients will be asked to perform a series of serial subtractions beginning at a given number which will be different for each repeated test and will be chosen by the tester from a fixed list of various numbers, with encouragement to perform calculations as quickly as possible; (2) Public speaking with anger recall: during this test, patients will be asked to give a speech on a recent situation in which they experienced anger to an audience of observers (two to three) after 1 minute of preparation. Prior to the speech, subjects are told that their speech will be evaluated on their description of the situation, as to what happened, what they thought, felt, what they did, and what happened as a result. If they run out of things to say, the research tech will prompt them with questions to elicit more content until the three minutes are up; (3) Mirror trace: during this test, patients will be asked to outline, as quickly as possible, a star from its reflection in a mirror. Each task will last 3 minutes and there will be a 6-minute rest period between tasks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 127 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Responses of Myocardial Ischemia to Escitalopram Treatment (REMIT Trial)
• Study Start Date: Sep 1, 2006
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Escitalopram Escitalopram treatment	Drug: Escitalopram; Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.; Other Names: Lexapro
Placebo Comparator: Placebo Placebo	Drug: Placebo; Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With an Absence of Mental Stress-induced Myocardial Ischemia (MSIMI) During the 3 Mental Stressors [Week 6]

   MSIMI is defined by the following: compared to rest, 1) any development of new abnormal wall motion; 2) reduction of LVEF 8% and/or; 3) deviation (depression or elevation) of ST-segment of ECG in 2 or more leads lasting for 3 consecutive beats, occurring during at least one of the 3 mental stress tasks.

2. Percentage of Participants With Overall Mental Stress-induced Myocardial Ischemia (MSIMI) [week 6]

   MSIMI is defined by the following: compared to rest, 1) any development of new abnormal wall motion; 2) reduction of LVEF 8% and/or; 3) deviation (depression or elevation) of ST-segment of ECG in 2 or more leads lasting for 3 consecutive beats, occurring during at least one of the 3 mental stress tasks.

Secondary Outcome Measures

1. Mental Stress Induced Change of Systolic Blood Pressure [Baseline, week 6]

   Blood pressure will be measured the last 3 minutes of the 20 minute calibration period (resting), every minute during the 3 minutes mental stress testing, the last 3 minutes of the 6 minute rest periods between mental stress testing, and every minute during and after the physical stress testing with an automatic oscillometric blood pressure monitor (Quinton Electronics). Mental Stress Induced Change of Systolic Blood Pressure will be calculated by taking the mean of the mental stress systolic blood pressure measurements minus the resting Systolic blood pressure. End point values adjusted for baseline values age and sex.

2. Mental Stress Induced Change of Diastolic Blood Pressure [Baseline, week 6]

   Blood pressure will be measured the last 3 minutes of the 20 minute calibration period (resting), every minute during the 3 minutes mental stress testing, the last 3 minutes of the 6 minute rest periods between mental stress testing, and every minute during and after the physical stress testing with an automatic oscillometric blood pressure monitor (Quinton Electronics). Mental Stress Induced Change of Diastolic Blood Pressure will be calculated by taking the mean of the mental stress Diastolic blood pressure measurements minus the resting Diastolic blood pressure. End point values adjusted for baseline values age and sex.

3. Percentage of Participants With Adverse Events [Baseline to week 6]

4. Beck Depression Inventory [6 week]

   The Beck Depression Inventory II (BDI-II) is a 21 question, self-administered measure of depressive symptoms. Score range, 0 to 63 (higher score=greater severity of depressive symptoms). End point values adjusted for baseline values age and sex.

5. Mental Stress Induced Change in Heart Rate [baseline, 6 weeks]

   A standard 12-lead Electrocardiograph (ECG) will be recorded at 1-minute intervals during the last 3 minutes of each rest period, the 3 minutes of the mental stress testing, and during exercise testing. Heart rate will be determined from the ECGs. Mental Stress Induced Change in heart rate will be calculated by taking the mean of the mental stress heart rate measurements minus the resting heart rate measurements. End point values adjusted for baseline values age and sex.

6. 5HTT, Serotonin Transporter Protein [week 6]

   End point values adjusted for baseline values age and sex.

7. Platelet Serotonin Binding Affinity Kd_100 [6 weeks]

   End point values adjusted for baseline values age and sex.

8. Perceived Stress Scale [6 weeks]

   Score range, 10 to 50 (higher score = greater levels of perceived stress). End point values adjusted for baseline values age and sex.

9. Cook-Medley Hostility (Ho) Scale [6 weeks]

   Score ranges: hostility, 0 to 27 (higher score=greater levels of hostility)/ End point values adjusted for baseline values age and sex.

10. Cook-Medley Hostility (Ho) Hostile Affect Sub-scale [6 weeks]

    hostile affect, 0 to 5 (higher score=greater levels of hostile affect). End point values adjusted for baseline values age and sex.

11. Spielberger State-Trait Anxiety Inventory Scales (STAI) [6 weeks]

    STAI measures anxiety. The questionnaire asks the patients how they feel and allows them to respond on a frequency scale that ranges from 1(not at all) to 4(almost always/very much so). Scores range from 20-80 and the higher the score the greater the anxiety level. This applies to both the Trait and State scales. End point values adjusted for baseline values age and sex.

12. Exercise Stressed-induced Myocardial Ischemia (ESIMI) [6 week]

    End point values adjusted for baseline values age and sex.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 21 or greater, less than 90

• Stable ischemic heart disease

Exclusion Criteria:

• Recent myocardial infarction, coronary artery bypass graft surgery, or other revascularization procedures (less than 3 months ago)

• Left ventricular ejection fraction(LVEF) < 15% measured by echocardiography, radionuclide ventriculography (RNV), or cardiac catheterization

• Life threatening arrhythmia or arrhythmia interrupting the interpretation of ischemia

• Unable to withdraw from anti-anginal medications during ischemic assessment phase

• Unable to perform exercise testing

• Pregnancy

• Current or previous history of bipolar disorder, cyclothymia, schizophrenia, schizoaffective or schizophreniform disorder, or other psychotic disorders

• Active suicidal ideation

• Current substance abuse or history of substance abuse in the previous 6 months

• Significant cardiac, pulmonary, metabolic, renal, hepatic disease, or malignancy, interfering with patient's participation in this study

• Seizure (history and/or present) with/without treatment

• Currently taking antidepressants that cannot be discontinued

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27710

Sponsors and Collaborators

• Duke University
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Wei Jiang, M.D., Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Jiang W, Velazquez EJ, Samad Z, Kuchibhatla M, Martsberger C, Rogers J, Williams R, Kuhn C, Ortel TL, Becker RC, Pristera N, Krishnan R, O'Connor CM. Responses of mental stress-induced myocardial ischemia to escitalopram treatment: background, design, and method for the Responses of Mental Stress Induced Myocardial Ischemia to Escitalopram Treatment trial. Am Heart J. 2012 Jan;163(1):20-6. doi: 10.1016/j.ahj.2011.09.018. Epub 2011 Nov 14.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT00574847
• Other Study ID Numbers: Pro00009555; R01HL085704-01; 8640-07-8R1ER
• First Posted: Dec 17, 2007
• Last Update Posted: Aug 5, 2015
• Last Verified: Jul 1, 2015

• Keywords provided by Duke University: ischemic heart disease; mental stress-induced myocardial ischemia; escitalopram
• Additional relevant MeSH terms: Myocardial Ischemia; Coronary Artery Disease; Ischemia; Citalopram

Study Results

Participant Flow

Recruitment Details	We screened all patients with Coronary Heart Disease (CHD) who visited Duke cardiology clinics. Patients 21 years or older were eligible to participate if they had CHD, as documented by angiographic findings of coronary artery stenosis of 70% or greater, history of MI, or history of cardiac revascularization.
Pre-assignment Detail	25527 underwent initial screening. 22833 excluded due to reasons including no CHD, atrial fibrillation/arrhythmia, psychiatric disorder, and LVEF less than 30%. 2294 did not provide consent. 65 excluded due to medical conditions. 203 excluded due to no MSIMI or inability to undergo mental stress testing. 5 more declined to undergo randomization.

Arm/Group Title	Escitalopram	Placebo
Arm/Group Description	Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.	Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Period Title: Overall Study
STARTED	64	63
COMPLETED	56	56
NOT COMPLETED	8	7

Baseline Characteristics

Arm/Group Title	Escitalopram	Placebo	Total
Arm/Group Description	Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.	Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.	Total of all reporting groups
Overall Participants	64	63	127
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.5 (9.3)	61.4 (11.5)	64.0 (10.7)
Sex: Female, Male (Count of Participants)
Female	11 17.2%	15 23.8%	26 20.5%
Male	53 82.8%	48 76.2%	101 79.5%
History of Depression (participants) [Number]
Number [participants]	11 17.2%	10 15.9%	21 16.5%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With an Absence of Mental Stress-induced Myocardial Ischemia (MSIMI) During the 3 Mental Stressors
Description	MSIMI is defined by the following: compared to rest, 1) any development of new abnormal wall motion; 2) reduction of LVEF 8% and/or; 3) deviation (depression or elevation) of ST-segment of ECG in 2 or more leads lasting for 3 consecutive beats, occurring during at least one of the 3 mental stress tasks.
Time Frame	Week 6

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT)

Arm/Group Title	Escitalopram	Placebo
Arm/Group Description	Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.	Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Measure Participants	64	63
Number (95% Confidence Interval) [percentage of participants]	34.2 53.4%	17.5 27.8%

2. Secondary Outcome

Title	Mental Stress Induced Change of Systolic Blood Pressure
Description	Blood pressure will be measured the last 3 minutes of the 20 minute calibration period (resting), every minute during the 3 minutes mental stress testing, the last 3 minutes of the 6 minute rest periods between mental stress testing, and every minute during and after the physical stress testing with an automatic oscillometric blood pressure monitor (Quinton Electronics). Mental Stress Induced Change of Systolic Blood Pressure will be calculated by taking the mean of the mental stress systolic blood pressure measurements minus the resting Systolic blood pressure. End point values adjusted for baseline values age and sex.
Time Frame	Baseline, week 6

Outcome Measure Data

Analysis Population Description

ITT, 9 subjects excluded from analysis due to missing data.

Arm/Group Title	Escitalopram	Placebo
Arm/Group Description	Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.	Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Measure Participants	62	56
Mean (95% Confidence Interval) [mm Hg]	19.3	23.6

3. Secondary Outcome

Title	Mental Stress Induced Change of Diastolic Blood Pressure
Description	Blood pressure will be measured the last 3 minutes of the 20 minute calibration period (resting), every minute during the 3 minutes mental stress testing, the last 3 minutes of the 6 minute rest periods between mental stress testing, and every minute during and after the physical stress testing with an automatic oscillometric blood pressure monitor (Quinton Electronics). Mental Stress Induced Change of Diastolic Blood Pressure will be calculated by taking the mean of the mental stress Diastolic blood pressure measurements minus the resting Diastolic blood pressure. End point values adjusted for baseline values age and sex.
Time Frame	Baseline, week 6

Outcome Measure Data

Analysis Population Description

ITT, 9 subjects excluded from the analysis due to missing data.

Arm/Group Title	Escitalopram	Placebo
Arm/Group Description	Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.	Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Measure Participants	62	56
Mean (95% Confidence Interval) [mm Hg]	11.4	12.2

4. Secondary Outcome

Title	Percentage of Participants With Adverse Events
Time Frame	Baseline to week 6

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Escitalopram	Placebo
Arm/Group Description	Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.	Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Measure Participants	64	63
Number [percentage of participants]	71.9 112.3%	44.4 70.5%

5. Secondary Outcome

Title	Beck Depression Inventory
Description	The Beck Depression Inventory II (BDI-II) is a 21 question, self-administered measure of depressive symptoms. Score range, 0 to 63 (higher score=greater severity of depressive symptoms). End point values adjusted for baseline values age and sex.
Time Frame	6 week

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Escitalopram	Placebo
Arm/Group Description	Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.	Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Measure Participants	64	63
Mean (95% Confidence Interval) [units on a scale]	7.4	7.0

6. Secondary Outcome

Title	Mental Stress Induced Change in Heart Rate
Description	A standard 12-lead Electrocardiograph (ECG) will be recorded at 1-minute intervals during the last 3 minutes of each rest period, the 3 minutes of the mental stress testing, and during exercise testing. Heart rate will be determined from the ECGs. Mental Stress Induced Change in heart rate will be calculated by taking the mean of the mental stress heart rate measurements minus the resting heart rate measurements. End point values adjusted for baseline values age and sex.
Time Frame	baseline, 6 weeks

Outcome Measure Data

Analysis Population Description

ITT, 10 subjects excluded from analysis due to missing data.

Arm/Group Title	Escitalopram	Placebo
Arm/Group Description	Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.	Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Measure Participants	61	56
Mean (95% Confidence Interval) [beats/minute]	6.34	9.1

7. Secondary Outcome

Title	5HTT, Serotonin Transporter Protein
Description	End point values adjusted for baseline values age and sex.
Time Frame	week 6

Outcome Measure Data

Analysis Population Description

ITT, 29 subjects excluded from analysis due to missing data.

Arm/Group Title	Escitalopram	Placebo
Arm/Group Description	Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.	Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Measure Participants	48	50
Mean (95% Confidence Interval) [fmol/mg]	139.7	160.4

8. Secondary Outcome

Title	Platelet Serotonin Binding Affinity Kd_100
Description	End point values adjusted for baseline values age and sex.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

ITT, 27 subjects were excluded from analysis due to missing data.

Arm/Group Title	Escitalopram	Placebo
Arm/Group Description	Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.	Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Measure Participants	50	50
Mean (95% Confidence Interval) [nM]	4202.4	210.1

9. Secondary Outcome

Title	Perceived Stress Scale
Description	Score range, 10 to 50 (higher score = greater levels of perceived stress). End point values adjusted for baseline values age and sex.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Escitalopram	Placebo
Arm/Group Description	Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.	Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Measure Participants	64	63
Mean (95% Confidence Interval) [units on a scale]	21.4	21.8

10. Secondary Outcome

Title	Cook-Medley Hostility (Ho) Scale
Description	Score ranges: hostility, 0 to 27 (higher score=greater levels of hostility)/ End point values adjusted for baseline values age and sex.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

ITT, 1 subject excluded from analysis due to missing data.

Arm/Group Title	Escitalopram	Placebo
Arm/Group Description	Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.	Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Measure Participants	64	62
Mean (95% Confidence Interval) [units on a scale]	9.9	10.3

11. Secondary Outcome

Title	Cook-Medley Hostility (Ho) Hostile Affect Sub-scale
Description	hostile affect, 0 to 5 (higher score=greater levels of hostile affect). End point values adjusted for baseline values age and sex.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

ITT, 1 subject excluded from analysis due to missing data.

Arm/Group Title	Escitalopram	Placebo
Arm/Group Description	Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.	Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Measure Participants	64	62
Mean (95% Confidence Interval) [units on a scale]	1.6	1.8

12. Secondary Outcome

Title	Spielberger State-Trait Anxiety Inventory Scales (STAI)
Description	STAI measures anxiety. The questionnaire asks the patients how they feel and allows them to respond on a frequency scale that ranges from 1(not at all) to 4(almost always/very much so). Scores range from 20-80 and the higher the score the greater the anxiety level. This applies to both the Trait and State scales. End point values adjusted for baseline values age and sex.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Escitalopram	Placebo
Arm/Group Description	Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.	Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Measure Participants	64	63
Trait	31.2	32.0
State	27.9	29.5

13. Secondary Outcome

Title	Exercise Stressed-induced Myocardial Ischemia (ESIMI)
Description	End point values adjusted for baseline values age and sex.
Time Frame	6 week

Outcome Measure Data

Analysis Population Description

ITT, 7 subject excluded from analysis due to missing data.

Arm/Group Title	Escitalopram	Placebo
Arm/Group Description	Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.	Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Measure Participants	59	61
Number (95% Confidence Interval) [percentage of change]	45.8	52.5

14. Primary Outcome

Title	Percentage of Participants With Overall Mental Stress-induced Myocardial Ischemia (MSIMI)
Description	MSIMI is defined by the following: compared to rest, 1) any development of new abnormal wall motion; 2) reduction of LVEF 8% and/or; 3) deviation (depression or elevation) of ST-segment of ECG in 2 or more leads lasting for 3 consecutive beats, occurring during at least one of the 3 mental stress tasks.
Time Frame	week 6

Outcome Measure Data

Analysis Population Description

Subjects who completed.

Arm/Group Title	Escitalopram	Placebo
Arm/Group Description	Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.	Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Measure Participants	56	56
Number [percentage of participants]	66.1 103.3%	83.9 133.2%

Adverse Events

Arm/Group Title	Escitalopram		Placebo
Arm/Group Description	Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.		Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
All Cause Mortality
	Escitalopram		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Escitalopram		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/64 (4.7%)		1/63 (1.6%)
Cardiac disorders
Death	1/64 (1.6%)		0/63 (0%)
unstable angina	1/64 (1.6%)		1/63 (1.6%)
Nervous system disorders
Confusion, Hallucination	1/64 (1.6%)		0/63 (0%)
Other (Not Including Serious) Adverse Events
	Escitalopram		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	46/64 (71.9%)		28/63 (44.4%)
Cardiac disorders
irregular heartbeat	0/64 (0%)		2/63 (3.2%)
Gastrointestinal disorders
constipation	18/64 (28.1%)		11/63 (17.5%)
General disorders
fatigue	19/64 (29.7%)		9/63 (14.3%)
Infections and infestations
sinusitis	1/64 (1.6%)		0/63 (0%)
Musculoskeletal and connective tissue disorders
cramping in legs	3/64 (4.7%)		2/63 (3.2%)
Nervous system disorders
CNS symptom	17/64 (26.6%)		13/63 (20.6%)
Reproductive system and breast disorders
sexual dysfunction	10/64 (15.6%)		4/63 (6.3%)
Skin and subcutaneous tissue disorders
burning sensation	1/64 (1.6%)		0/63 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.