search
Back to results

Antidepressants to Promote Recovery of Cardiac Patients Suffering From Depression (ARCADE)

Primary Purpose

Acute Coronary Syndrome, Major Depressive Episode

Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Citalopram
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre de recherche du CHUM
  • Montreal Heart Insitute

Outcomes

Primary Outcome Measures

Changes from baseline to 12 weeks in depression levels on the 24-item Hamilton Depression Rating Scale (HAMD-24)
Administered centrally by telephone

Secondary Outcome Measures

Changes from baseline to 12 weeks in depression levels on the Inventory of Depressive Severity Clinician Version (IDS-C)
Administered centrally by telephone
Changes from baseline to 12 weeks in self-reported depression symptoms on the Beck Depression Inventory-II (BDI-II)
self-report
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)
Changes from baseline to 12 weeks in kynurenine levels
Changes from baseline to 12 weeks in tryptophan levels
Changes from baseline to 12 weeks in neopterin levels
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

Full Information

First Posted
April 1, 2010
Last Updated
January 27, 2016
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Canadian Institutes of Health Research (CIHR), Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal Heart Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT01099592
Brief Title
Antidepressants to Promote Recovery of Cardiac Patients Suffering From Depression
Acronym
ARCADE
Official Title
Predictors of Depression Treatment Response Following an Acute Coronary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
inability to recruit
Study Start Date
November 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Canadian Institutes of Health Research (CIHR), Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal Heart Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Major Depressive Episode

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Citalopram
Other Intervention Name(s)
celexa
Intervention Description
All patients will take citalopram once daily. Medication will be commercial tablets of 20 mg or 40 mg. All patients will start on a half dose of 10 mg and, if there are no severe side effects, will be increased to 20 mg after 1 week, and if the HAMD-24 at 6 weeks is not < 8, the dose will increase to 40 mg.
Primary Outcome Measure Information:
Title
Changes from baseline to 12 weeks in depression levels on the 24-item Hamilton Depression Rating Scale (HAMD-24)
Description
Administered centrally by telephone
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes from baseline to 12 weeks in depression levels on the Inventory of Depressive Severity Clinician Version (IDS-C)
Description
Administered centrally by telephone
Time Frame
12 weeks
Title
Changes from baseline to 12 weeks in self-reported depression symptoms on the Beck Depression Inventory-II (BDI-II)
Description
self-report
Time Frame
12 weeks
Title
Changes from baseline to 12 weeks in Inflammatory markers
Description
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)
Time Frame
12 weeks
Title
Changes from baseline to 12 weeks in kynurenine levels
Time Frame
12 weeks
Title
Changes from baseline to 12 weeks in tryptophan levels
Time Frame
12 weeks
Title
Changes from baseline to 12 weeks in neopterin levels
Time Frame
12 weeks
Title
Changes from baseline to 12 weeks in cognitive function
Description
scores on the Trail Making Tests A and B, Digit Symbol Substitution Test, Rey Auditory Verbal Learning Test
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Frasure-Smith, PhD
Organizational Affiliation
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
François Lespérance, MD
Organizational Affiliation
Département de psychiatrie, Centre Hospitalier de l'Université de Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de recherche du CHUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Montreal Heart Insitute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Antidepressants to Promote Recovery of Cardiac Patients Suffering From Depression

We'll reach out to this number within 24 hrs