Phase 4 N=127 Randomized Quadruple-blind Treatment

Responses of Myocardial Ischemia to Escitalopram Treatment

Myocardial Ischemia

Bottom Line

View on ClinicalTrials.gov: NCT00574847 ↗

Enrolled (actual)

127

Serious AEs

3.2%

Results posted

Aug 2015

Primary outcome: Primary: Percentage of Participants With an Absence of Mental Stress-induced Myocardial Ischemia (MSIMI) During the 3 Mental Stressors — 34.2; 17.5 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Escitalopram (Drug); Placebo (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Duke University
Primary completion: Nov 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With an Absence of Mental Stress-induced Myocardial Ischemia (MSIMI) During the 3 Mental Stressors	34.2; 17.5	—
PRIMARY Percentage of Participants With Overall Mental Stress-induced Myocardial Ischemia (MSIMI)	66.1; 83.9	—
SECONDARY Mental Stress Induced Change of Systolic Blood Pressure	19.3; 23.6	—
SECONDARY Mental Stress Induced Change of Diastolic Blood Pressure	11.4; 12.2	—
SECONDARY Percentage of Participants With Adverse Events	71.9; 44.4	—
SECONDARY Beck Depression Inventory	7.4; 7.0	—
SECONDARY Mental Stress Induced Change in Heart Rate	6.34; 9.1	—
SECONDARY 5HTT, Serotonin Transporter Protein	139.7; 160.4	—
SECONDARY Platelet Serotonin Binding Affinity Kd_100	4202.4; 210.1	—
SECONDARY Perceived Stress Scale	21.4; 21.8	—
SECONDARY Cook-Medley Hostility (Ho) Scale	9.9; 10.3	—
SECONDARY Cook-Medley Hostility (Ho) Hostile Affect Sub-scale	1.6; 1.8	—
SECONDARY Spielberger State-Trait Anxiety Inventory Scales (STAI)	31.2; 32.0; 27.9; 29.5	—
SECONDARY Exercise Stressed-induced Myocardial Ischemia (ESIMI)	45.8; 52.5	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00574847). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.