Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-24 @ 3:37 PM
NCT ID:
NCT01099592
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01099592
Study Brief:
Protocol Section:
NCT01099592