Vortioxetine in Patients With Major Depressive Disorder and Coronary Artery Disease

NCT02454426 | Withdrawn Early Phase 1

• 1 other identifier: TakedaHRV
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; Coronary Artery Disease

Keywords

Depression; Heart disease

Outcome Measures

Primary Outcomes (1)

• Severity of depressive episodes measured using the Montgomery-Asberg Depression Rating Scale (MADRS)

  Baseline-Week 10

Study Arms (1)

Open-Label Treatment

EXPERIMENTAL

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

Interventions

Vortioxetine DRUG

open label treatment

Also known as: Brintellix

Open-Label Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DSM-5 diagnosis of a major depressive disorder based on clinical evaluation by the study psychiatrist
• At least moderate severity of depression as indicated by a Montgomery-Asberg Depression Rating Scale (MADRS) score of 22 or greater
• 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
• 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.)

You may not qualify if:

• 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.
• 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)
• 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);
• 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
• Patients who have had a myocardial infarction within 30 days of the screening visit
• Any cardiovascular condition that is unstable or decompensated
• In the opinion of the Investigators, the patient is at significant risk of cardiovascular adverse events
• Coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI)/ stenting within three months of the screening visit
• Admission to a hospital for any cardiac condition within three months of the screening visit
• Decompensated heart failure within 6 months of the screening visit
• QTc prolongation (screening ECG with QTc ≥ 450 msec for men or QTc ≥ 470 msec for women) using QTc Fridericia correction
• Second-degree (if Mobitz II) or third-degree atrioventricular block
• Heart rate on ECG of ≤ 50 bpm or ≥ 120 bpm or any heart rate that is clinically symptomatic

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Takeda: collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Coronary Artery Disease; Depression; Heart Diseases

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Coronary Disease; Myocardial Ischemia; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Rajnish Mago, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2015
• First Posted: May 27, 2015
• Study Start: April 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 25, 2016

Record last verified: 2016-08

Locations

US (1)