Acute Coronary Syndrome Clinical Trial
— ARCADEOfficial title:
Predictors of Depression Treatment Response Following an Acute Coronary Syndrome
Depression is frequently seen in cardiac patients. It has been shown that depression often has a negative impact on the course of coronary disease. More recently, research has demonstrated that some antidepressants can be used safely to treat depressed coronary patients. Although the majority of patients improve substantially with antidepressant treatment, a significant proportion do not respond to antidepressants. This project seeks to better understand why depression does not improve equally well in all patients. Ultimately, the hope is to improve the treatments available to people affected by both cardiac disease and depression, and to help select the best type of treatment in advance for each individual based on his or her personal history, and biological characteristics.
Status | Terminated |
Enrollment | 7 |
Est. completion date | April 2011 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - At least 18 years old - Diagnostic and Statical Manual-Revision 4 (DSM-IV) diagnosis of current MDD based on the Structured Clinical Interview for Depression (SCID) - Duration of major depressive disorder (MDD) at least 4 weeks at baseline - Hospital discharge for an acute coronary syndrome 4 to 24 weeks prior to baseline - No coronary artery bypass (CABG) surgery during or since the admission for the index event, and no plan for CABG during the next 4 months after baseline - Stable coronary artery disease (CAD) based on physician's clinical judgement - Provision of informed consent Exclusion Criteria - Significant cognitive problems (Mini-mental Status Exam, MMSE < 24) Structured Clinical Interview for Depression (SCID) documented bipolar disorder or use of lithium or anticonvulsants (e.g. tegretol, depakene, neurontin) for mood disorder - MINI International Neuropsychiatric Interview (MINI) documented major depression with psychotic features - MINI documented current or recent (within 12 months) substance abuse or dependence - Serious suicide risk based on clinical judgment - Currently taking antidepressants (including St. John's Wort) - Absence of response to a previous adequate trial of citalopram - Lifetime evidence of citalopram intolerance or lifetime evidence of intolerance to two or more other SSRIs - 2 or more previous unsuccessful trials of treatment for the current depressive episode - Depression due to a general medical condition based on clinical judgment (e.g., clinical hypothyroidism) - Cold, flu or other infection or dental work (including teeth cleaning) in 14 days before baseline - Use of antibiotics or steroids (other than topical steroids) in 14 days before baseline - Participation in any randomized clinical trial - Inability to speak French or English - Investigator's judgement that patient is unable/unwilling to comply with study regimen |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Centre de recherche du CHUM | Montreal | Quebec |
Canada | Montreal Heart Insitute | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Centre hospitalier de l'Université de Montréal (CHUM) | Canadian Institutes of Health Research (CIHR), Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal Heart Institute |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes from baseline to 12 weeks in depression levels on the 24-item Hamilton Depression Rating Scale (HAMD-24) | Administered centrally by telephone | 12 weeks | No |
Secondary | Changes from baseline to 12 weeks in depression levels on the Inventory of Depressive Severity Clinician Version (IDS-C) | Administered centrally by telephone | 12 weeks | No |
Secondary | Changes from baseline to 12 weeks in self-reported depression symptoms on the Beck Depression Inventory-II (BDI-II) | self-report | 12 weeks | No |
Secondary | Changes from baseline to 12 weeks in Inflammatory markers | e.g. Tumor necrosis factor-alpha (TNF-alpha), Interleukin-6 (IL-6), Interleukin-10 (IL-10), C-Reactive Protein (CRP), Soluble intercellular adhesion molecule-1 (s-ICAM1) | 12 weeks | No |
Secondary | Changes from baseline to 12 weeks in kynurenine levels | 12 weeks | No | |
Secondary | Changes from baseline to 12 weeks in tryptophan levels | 12 weeks | No | |
Secondary | Changes from baseline to 12 weeks in neopterin levels | 12 weeks | No | |
Secondary | Changes from baseline to 12 weeks in cognitive function | scores on the Trail Making Tests A and B, Digit Symbol Substitution Test, Rey Auditory Verbal Learning Test | 12 weeks | No |
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