Alice Rasmussen

Effects of escitalopram in prevention of depression in patients with acute coronary syndrome (DECARD).

OBJECTIVE Depression is a major problem in patients after acute coronary syndrome (ACS) with negative impact on survival and quality of life. No studies have examined prevention of post-ACS depression. We examined whether treatment with escitalopram can prevent post-ACS depression. METHODS We have conducted a randomised controlled trial. Between November 2004 and December 2007, 240 patients in 2 university hospitals in Copenhagen, Denmark, with ACS were randomised. Patients were randomised to a double-blind treatment with escitalopram or matching placebo for 1 year. Main outcome measure was the incidence of ICD-10 depressive episode. RESULTS Of 120 patients treated with escitalopram 2 developed depression versus 10 in placebo treated group (log rank, p=0.022). In multivariate analysis treatment with placebo and high Hamilton Depression Scale score at baseline were associated with development of depression. Patients were well matched at baseline. CONCLUSION Twelve months treatment with escitalopram prevented depression in post-ACS patients.

Mental disorders and general well-being in cardiology outpatients--6-year survival.

OBJECTIVE Long-term survival in a sample of cardiology outpatients with and without mental disorders and other psychosocial risk factors. METHODS In a cardiology outpatient setting, 103 consecutive patients were asked to participate in the study. Of these, 86 were included and screened for mental disorder with the Primary Care Evaluation of Mental Disorders; Structured Clinical Interview for DSM-III-R, Non-Patient Edition, psychosis screening; the Clock Drawing Test; and the WHO-5 Well-Being Index. The cardiologists were asked in each patient to rate the severity of somatic disease and mental problems on visual analogue scales (VAS-somatic and VAS-mental). Cardiac diagnosis, noncardiac comorbidity, history of mental disorder, and the number of daily social contacts were noted. Survival was followed for 6 years. RESULTS At baseline, 33 (38.4%) patients had mental disorder, 6 dementia, 11 major depression, 6 minor depression, 6 anxiety disorder, 2 unspecified somatoform disorder, 1 alcohol abuse, and 1 psychosis. At 6 years of follow-up, 40 (47%) patients were deceased, 17 (48%) of those with and 23 (46%) of those without mental disorder. In a survival analysis, mortality was significantly predicted by age [hazard ratio (HR), 1.058], WHO-5 (HR, 0.977), the number of social contacts (HR, 0.699), VAS-somatic (HR, 1.016), and cardiac diagnosis (HR, 0.333). CONCLUSION In chronic heart disease, well-being and social support seem related to long-term survival.

Cardiovascular Safety of One-Year Escitalopram Therapy in Clinically Nondepressed Patients With Acute Coronary Syndrome: Results From the DEpression in Patients With Coronary ARtery Disease (DECARD) Trial.

Background: Selective serotonin reuptake inhibitors are commonly used for treatment of depression in patients with cardiac diseases. However, evidence of cardiovascular (CV) safety from randomized trials is based on studies of no longer than 6-month duration. We examined the CV safety of 1-year treatment with Selective serotonin reuptake inhibitor escitalopram compared with placebo in patients with recent acute coronary syndrome (ACS). Methods: The DECARD (DEpression in patients with Coronary ARtery Disease) trial assessed the prophylactic effect of escitalopram on depression after ACS. Two hundred forty patients were randomized to escitalopram 10-mg daily or matching placebo for 1 year. Serial measures of CV safety including clinical and biochemical parameters, 24-hour electrocardiogram monitor, resting electrocardiogram, and echocardiographic assessment were obtained. Results: Escitalopram and placebo groups were comparable at baseline with regard to age, gender, sociodemography, depression score, risk factor profile, severity of heart disease, and medications. Dropout rates defined as withdrawal for any reason or lost to follow-up during the 12-month study period was 27.2% in the escitalopram group and 23.4% in the placebo group (NS). There were no statistically significant differences between intervention groups in any of CV safety measures including the incidence of ventricular arrhythmia and episodes of ST-segment depression, length of QTc, and systolic and diastolic echocardiographic measures at the 12-month follow-up between groups. After 12 months, 16 and 13 major adverse events (death, recurrent ACS, or acute revascularization) were recorded in the escitalopram and placebo group, respectively (NS). Conclusions: One-year escitalopram treatment was safe and well tolerated in patients with recent ACS.

Rationale, design and methodology of a double-blind, randomized, placebo-controlled study of escitalopram in prevention of Depression in Acute Coronary Syndrome (DECARD)

BackgroundThe prevalence of depression in patients with acute coronary syndrome, i.e. myocardial infarction and unstable angina, is higher than in the general population. The prevalence of anxiety is higher as well. Both depression and anxiety are associated with poor cardiac outcomes and higher mortality. Comorbid depression in patients with acute coronary syndrome often goes undiagnosed, and it is therefore a challenging task to prevent this risk factor. The study of DEpression in Coronary ARtery Disease (DECARD) is designed to examine if it is possible to prevent depression in patients with acute coronary syndrome.MethodsTwo hundred forty non-depressed patients with acute coronary syndrome are randomized to treatment with either escitalopram or placebo for 1 year. Psychiatric and cardiac assessment of patients is performed to evaluate the possibility of preventing depression. Diagnosis of depression and Hamilton Depression Scale are the primary outcome measures.DiscussionThis is the first study of prevention of depression in patients after acute coronary syndrome with a selective serotonin reuptake inhibitor.Trial Registrationhttp://www.ClinicalTrials.gov Identifier: NCT00140257

Screening for mental disorders in cardiology outpatients.

The objective of the study was to compare the frequency of mental disorders in cardiology outpatients to the number of patients with psychological problems identified by cardiologists. In a cardiology outpatient service, 103 consecutive patients were asked to participate in the study. Of these 86 were included and screened for mental disorder with the Primary Care Evaluation of Mental Disorders (PRIME-MD), Structured Clinical Interview for DSM-IV (SCID) psychosis screening, the Clock Drawing Test, and the WHO-5 Well-being Index. The cardiologists were asked to rate the severity of somatic and mental problems in each patient on visual analogue scales (VAS-som and VAS-men). The current treatments, including psychiatric and psychological treatments, were noted, and the survival was followed for 3 years. Of the 86 patients included, 34 (40%) had a diagnosis of mental disorder. Eleven (12.8%) had major depression, six (7.0%) minor depression, six (7.0%) anxiety disorder, two unspecified somatoform disorder, seven (8.1%) dementia, one alcohol abuse and one psychosis. Three of the patients were in long-term psychopharmacological treatment. Although the cardiologists predicted mental disorder significantly better than chance, none of the patients was in relevant treatment for their mental disorder. At 3-year follow-up, 20 (24%) of the patients had died. Age and severity of heart disease predicted mortality, while the presence of a mental disorder did not. Mental disorders, especially depression, were frequent in cardiology outpatients. Even in cases where the cardiologists identified psychological problems, the diagnosis had no consequence, as none of the patients was offered relevant treatment.

A double-blind placebo-controlled study of sertraline in the prevention of depression in stroke patients

The authors tested the effect of sertraline in the prevention of poststroke depression. After experiencing an acute ischemic stroke, nondepressed patients (N=137) were randomly assigned to 12 months of double-blind treatment with either sertraline (N=70) or placebo (N=67). Kaplan-Meier analysis showed sertraline to have significantly superior prophylactic efficacy compared with placebo. Two definitions of clinical depression were used: total score >18 on the HAM-D(17) and score >or=9 on the HAM-D(6). Approximately 10% of the sertraline-treated group developed depression according to either definition, whereas 30% developed depression in the placebo group. On the HAM-D(6) the superiority of sertraline to placebo was demonstrated already after 6 weeks of therapy. Treatment was well tolerated; patients treated with sertraline experienced significantly fewer adverse events.

Mindfulness-based cognitive therapy for multiple chemical sensitivity: a study protocol for a randomized controlled trial.

BackgroundMultiple chemical sensitivity (MCS) is a condition characterized by recurrent, self-reported symptoms from multiple organ systems, attributable to exposure to a wide range of chemically unrelated substances at low levels. The pathophysiology is unknown, and affected individuals generally favor avoidance of the symptom triggering substances as a coping strategy. The impact of MCS on daily life may thus be severe. An intervention that may effectively reduce the impact of MCS, alleviate the symptoms and the psychological distress associated with the condition is therefore highly needed. In this study we will assess the effects of a mindfulness-based cognitive (MBCT) program on MCS.Methods/DesignUsing a randomized controlled design (RCT), we will compare MBCT with treatment as usual (TAU). The MBCT intervention will include 8 weekly 2.5 hour sessions, and 45 minutes of mindfulness home practice 6 days each week. Participants will be asked to complete questionnaires at baseline, post-treatment, and at 6 and 12 months’ follow-up. Based on sample size estimation, 82 participants will be randomized to either the MBCT intervention or to TAU. The primary outcome will be a measure of the impact of MCS on the participants’ lives. The secondary outcome measures are physical symptoms of psychological distress, perceived stress, illness perceptions, QOL, and work ability. Lastly, we will assess whether any effect of MBCT on the primary effect measure is mediated by level of mindfulness, self-compassion, perceived stress, and rumination.DiscussionThis trial will provide important information on the effects of MBCT on MCS.Trials registrationClinical trials identifier NCT01240395

Mindfulness-based cognitive therapy (MBCT) for multiple chemical sensitivity (MCS): Results from a randomized controlled trial with 1 year follow-up

OBJECTIVE Multiple chemical sensitivity (MCS) is a medically unexplained condition characterized by symptoms from multiple organ systems following the perception of common odorants. The condition can cause severe functional impairment for afflicted individuals. The aim of this study was to assess the effects of mindfulness-based cognitive therapy (MBCT) for individuals with MCS. METHODS The intention-to-treat sample (ITT) included 69 individuals who had been randomized to either MBCT or treatment as usual (TAU). The primary outcome measure was the Quick Environmental Exposure and Sensitivity Inventory (QEESI), which measures the following aspects of MCS impact of MCS on daily life, symptoms, and reactions following chemical exposures. Secondary outcome measures included the Brief Illness Perception Questionnaire (BIPQ) and the anxiety and depression subscales of the symptom checklist 92 (SCL-92). Participants were assessed at baseline and post treatment, and at follow-up periods of 6- and 12-months. RESULTS We found no effect of MBCT on the primary outcome, nor did we find an effect on levels of depression or anxiety. We did, however, find positive changes in illness perceptions, which were sustained at 12-month follow-up. Dropout rates were low, suggesting MBCT was well received and regarded as an acceptable intervention by individuals with MCS. CONCLUSIONS Overall, these results suggest that MBCT does not change overall illness status in individuals with MCS, but that MBCT positively changes emotional and cognitive representations. Possible explanations for these results are discussed.

Comparison of participants and non-participants in a randomized study of prevention of depression in patients with acute coronary syndrome.

Background: The prevalence of depression and anxiety in patients after acute coronary syndrome (ACS) is higher than in the general population. In a study on prevention of post-ACS depression, more than half of eligible patients declined participation. Aims: The aim of this study was to evaluate whether symptoms of depression and anxiety in participants and non-participants predicted participation in the study. Methods: This substudy was conducted between May 2005 and April 2007. Patients with ACS, eligible for the study (n=302) were asked four questions on depression and anxiety from the Primary Care Evaluation of Mental Disorders (PRIME-MD) screening questionnaire. Results: The PRIME-MD screening data were available on 232 patients (76.8% of eligible patients). Thirty-eight (35.5%) of 107 participants and 30 (24.0%) of 125 non-participants had a positive screening for depression (NS), and 47 (43.9%) participants and 55 (44%) non-participants were screened positive for anxiety (NS). Non-participants were older (P=0.002), while no significant differences in gender or cardiac diagnosis were found. Conclusions: Symptoms of depression and anxiety were highly prevalent in patients after ACS but did not predict participation in the study of prevention of depression.

Prevention of depression in patients with acute coronary syndrome (DECARD) randomized trial: effects on and by self-reported health.

Escitalopram may prevent depression following acute coronary syndrome. We sought to estimate the effects of escitalopram on self‐reported health and to identify subgroups with higher efficacy.