Antidepressants to Promote Recovery of Cardiac Patients Suffering From Depression

NCT01099592 | Terminated Phase 4

• 1 other identifier: CE 10.004
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Coronary Syndrome; Major Depressive Episode

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

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

  12 weeks

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

  12 weeks

• Changes from baseline to 12 weeks in Inflammatory markers

  12 weeks

• Changes from baseline to 12 weeks in kynurenine levels

  12 weeks

• Changes from baseline to 12 weeks in tryptophan levels

  12 weeks

Interventions

Citalopram DRUG

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.

Also known as: celexa

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Centre de Recherche du Centre Hospitalier de l'Université de Montréal: collaborator
• Montreal Heart Institute: collaborator

Study Sites (2)

Centre de recherche du CHUM

Montreal, Quebec, H2L 4M1, Canada

Location

Montreal Heart Insitute

Montreal, Quebec, H3A 1A1, Canada

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Citalopram

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Nancy Frasure-Smith, PhD

  Centre de Recherche du Centre Hospitalier de l'Université de Montréal

  PRINCIPAL INVESTIGATOR

• François Lespérance, MD

  Département de psychiatrie, Centre Hospitalier de l'Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Researcher

Study Record Dates

• First Submitted: April 1, 2010
• First Posted: April 7, 2010
• Study Start: November 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: January 28, 2016

Record last verified: 2016-01

Locations

CA (2)