Clinical trial NCT01099592: Antidepressants to Promote Recovery of Cardiac Patients Suffering From Depression
Official title: Predictors of Depression Treatment Response Following an Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Major Depressive Episode
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Centre de Recherche du Centre Hospitalier de l'Université de Montréal
name: Montreal Heart Institute
First posted: 2010-04-07
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: In this study 140 patients who have had a recent hospitalization for an acute coronary syndrome and who have major depression will all receive 12 weeks of treatment with the antidepressant citalopram and regular clinical management visits from a mental health professional. The objective is to examine the characteristics of depressed cardiac patients who do and do not show an improvement in depression with citalopram treatment. There is evidence that the causes of depression may be different in some people with cardiac disease than in individuals who do not have heart problems, and these differences may be at least partially involved in determining response to antidepressant treatment. Inflammation, one of the body's responses to the development of atherosclerosis (hardening of the arteries and blockages in the heart) may be particularly important in producing depression in cardiac patients. There may also be changes in the body's metabolism of tryptophan, a protein that is involved in making serotonin, and levels of serotonin are often low in depression. Other factors thought to influence the development of depression include childhood experiences and personality factors. Heredity and family history also seem to play a role in some people with depression and heart disease. Finally, some patients experience sleep apnea, interruptions in breathing while they are asleep, that can contribute to both cardiac disease and depression.

Eligibility criteria: 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

Primary outcomes:
measure: Changes from baseline to 12 weeks in depression levels on the 24-item Hamilton Depression Rating Scale (HAMD-24)
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes from baseline to 12 weeks in depression levels on the Inventory of Depressive Severity Clinician Version (IDS-C)
timeFrame: 12 weeks
measure: Changes from baseline to 12 weeks in self-reported depression symptoms on the Beck Depression Inventory-II (BDI-II)
timeFrame: 12 weeks
measure: Changes from baseline to 12 weeks in Inflammatory markers
timeFrame: 12 weeks
measure: Changes from baseline to 12 weeks in kynurenine levels
timeFrame: 12 weeks
measure: Changes from baseline to 12 weeks in tryptophan levels
timeFrame: 12 weeks
measure: Changes from baseline to 12 weeks in neopterin levels
timeFrame: 12 weeks
measure: Changes from baseline to 12 weeks in cognitive function
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Centre de recherche du CHUM
state: Quebec
city: Montreal
country: Canada
facility: Montreal Heart Insitute
state: Quebec
Study officials:
affiliation: Centre de Recherche du Centre Hospitalier de l'Université de Montréal
name: Nancy Frasure-Smith, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Département de psychiatrie, Centre Hospitalier de l'Université de Montréal
name: François Lespérance, MD
role: PRINCIPAL_INVESTIGATOR
References: