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Vortioxetine in Patients With Major Depressive Disorder and Coronary Artery Disease

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ClinicalTrials.gov Identifier: NCT02454426
Recruitment Status : Withdrawn (PI left institution)
First Posted : May 27, 2015
Last Update Posted : August 25, 2016
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Thomas Jefferson University

Brief Summary:
This is a preliminary, open-label, clinical trial designed to assess the efficacy, safety, and tolerability of vortioxetine for the treatment of major depressive disorder in patients with coronary artery disease. In addition, the study will assess the effects of vortioxetine on heart rate variability in these patients.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Coronary Artery Disease Drug: Vortioxetine Early Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An 8-week, Open-Label Clinical Trial of the Efficacy and Safety of Vortioxetine in Patients With Major Depressive Disorder and Coronary Artery Disease
Study Start Date : April 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Open-Label Treatment
Patients will be initiated on vortioxetine 5 mg/day for 4 days, then increased to 10 mg/day. After the week 2 visit, patients will then be increased to 20 mg/day for the remainder of the study
Drug: Vortioxetine
open label treatment
Other Name: Brintellix




Primary Outcome Measures :
  1. Severity of depressive episodes measured using the Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Baseline-Week 10 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. DSM-5 diagnosis of a major depressive disorder based on clinical evaluation by the study psychiatrist
  2. At least moderate severity of depression as indicated by a Montgomery-Asberg Depression Rating Scale (MADRS) score of 22 or greater
  3. History of coronary artery disease as defined by:

    • History of coronary stenosis in one or more vessels that is greater ≥ 70% by coronary angiography or CT angiogram, OR
    • History of abnormal stress test (at least medium-sized, moderate, reversible defect), OR
    • History of documented myocardial infarction including ST elevation myocardial infarction or non-ST elevation myocardial infarction (with elevated troponins), OR
  4. Evidence of adequate treatment of the coronary artery disease as defined by at least one of the following that was done at least six months prior to the Screening visit, AND was followed by the patient being clinically stable in the opinion of a cardiologist who has evaluated the case:

    • Coronary artery bypass grafting (CABG)
    • Percutaneous coronary intervention (PCI)/ stenting
    • Adequate management with optimal medical treatment (such as one or more of the following medications: aspirin, beta blockers, a statin (e.g., atorvastatin), and either an ACE inhibitor or an angiotensin-receptor blocker.)

Key Exclusion Criteria:

Psychiatric Exclusion Criteria:

  1. Patients who in the past have failed to respond to a trial of vortioxetine at the minimum recommended dose (10 mg/day) or greater taken for at least six weeks, or had unacceptable adverse effects while taking vortioxetine.
  2. Patients must not have failed treatment with more than one antidepressant (taken at an adequate dose and for at least six weeks) in the current episode of major depressive disorder (i.e., did not have > 50% reduction in severity of depression based on patient history)
  3. Patients with a current primary DSM-5 diagnosis of:

    i) Delirium, dementia, amnestic, or other cognitive disorder; ii) Eating Disorder (including Anorexia Nervosa or Bulimia); iii) Obsessive Compulsive Disorder; iv) Panic Disorder; v) Post-Traumatic Stress Disorder (PTSD);

  4. Current or past (lifetime) DSM-5 diagnosis of:

    i) Bipolar I or II disorder; ii) Hypomanic episode iii) Substance-induced manic or hypomanic episode iii) Schizophrenia or other psychotic disorder

Cardiovascular Exclusion Criteria:

  1. Patients who have had a myocardial infarction within 30 days of the screening visit
  2. Any cardiovascular condition that is unstable or decompensated
  3. In the opinion of the Investigators, the patient is at significant risk of cardiovascular adverse events
  4. Coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI)/ stenting within three months of the screening visit
  5. Admission to a hospital for any cardiac condition within three months of the screening visit
  6. Decompensated heart failure within 6 months of the screening visit
  7. QTc prolongation (screening ECG with QTc ≥ 450 msec for men or QTc ≥ 470 msec for women) using QTc Fridericia correction
  8. Second-degree (if Mobitz II) or third-degree atrioventricular block
  9. Heart rate on ECG of ≤ 50 bpm or ≥ 120 bpm or any heart rate that is clinically symptomatic
  10. Premature Ventricular Contractions (PVCs) associated with clinical symptoms and/or any complex premature ventricular contractions (ie, PVCs that are frequent [> 30/hr] or ≥ 2 beats if multifocal, or show bigeminy, trigeminy, quadrigeminy, couplets, triplets [salvos], or the R on T phenomenon)
  11. Atrial fibrillation or flutter
  12. Supine (after patient has been supine for 5 minutes) systolic BP > 160 mm Hg or < 90 mm Hg or diastolic BP > 100 mm Hg or any systolic or diastolic BP that is symptomatic or clinically significant based on the opinion of the Principal Investigator
  13. Patients who are receiving warfarin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02454426


Locations
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Takeda
Investigators
Principal Investigator: Rajnish Mago, MD Thomas Jefferson University

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT02454426     History of Changes
Other Study ID Numbers: TakedaHRV
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: August 25, 2016
Last Verified: August 2016

Keywords provided by Thomas Jefferson University:
Depression
Heart disease

Additional relevant MeSH terms:
Disease
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Mood Disorders
Mental Disorders
Behavioral Symptoms
Vortioxetine
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists