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Acute Coronary SyndromePhase 4ARCADENCT01099592

Antidepressants to Promote Recovery of Cardiac Patients Suffering From Depression

A Phase 4 study testing Citalopram in people with Acute Coronary Syndrome and Major Depressive Episode, run by Centre hospitalier de l'Université de Montréal (CHUM) at 2 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Citalopram
Type of treatment
Pill or oral medicine
How many people
7 participants
Where
2 sitesCanada
Study dates
Nov 2010to Apr 2011
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Centre de recherche du CHUM

    Montreal, Quebec, H2L 4M1

  • Montreal Heart Insitute

    Montreal, Quebec, H3A 1A1

Other trials in Canada

About this study

Official 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.

Read the 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.

Being tested
Citalopram
Medical subject headings
Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CitalopramDrug

    Also called celexa

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes from baseline to 12 weeks in depression levels on the 24-item Hamilton Depression Rating Scale (HAMD-24)

    Administered centrally by telephone

    Measured: 12 weeks

Secondary outcomes (7)

  1. Changes from baseline to 12 weeks in depression levels on the Inventory of Depressive Severity Clinician Version (IDS-C)

    Administered centrally by telephone

    Measured: 12 weeks

  2. Changes from baseline to 12 weeks in self-reported depression symptoms on the Beck Depression Inventory-II (BDI-II)

    self-report

    Measured: 12 weeks

  3. 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)

    Measured: 12 weeks

  4. Changes from baseline to 12 weeks in kynurenine levels

    Measured: 12 weeks

  5. Changes from baseline to 12 weeks in tryptophan levels

    Measured: 12 weeks

  6. Changes from baseline to 12 weeks in neopterin levels

    Measured: 12 weeks

  7. 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

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionApr 2011
  4. Study completionApr 2011

Why it stopped: inability to recruit

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01099592
Sponsor's protocol ID
CE 10.004
Acronym
ARCADE
Status last verified
Jan 2016
First submitted
1 Apr 2010
Last updated
28 Jan 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Citalopram in people with Acute Coronary Syndrome and Major Depressive Episode, run by Centre hospitalier de l'Université de Montréal (CHUM) at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: inability to recruit). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes from baseline to 12 weeks in depression levels on the 24-item Hamilton Depression Rating Scale (HAMD-24) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01099592.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2016.

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