Vortioxetine in Prevention of Major Depressive Disorder Relapse in Adults

Eligibility Criteria

Men and women between the ages of 18 and 75:

  • Meeting the diagnostic criteria from the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) for recurrent MDD
  • Who have had at least 2 major depressive episodes prior to the current episode, with a current episode of between 8 weeks and 18 months duration from screening,and a Montgomery-Asberg Depression Rating Scale (MADRS) total score of 26
Exclusion Criteria
  • The subject has participated in 2 or more clinical studies in the year prior to screening, or has participated in a clinical trial for a psychiatric condition that is exclusionary per this protocol.
  • The subject is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (e.g.,spouse, parent, child, sibling) or may consent under duress.
  • The subject has one or more of the following:
  • Any current psychiatric disorder which is the primary focus of treatment other than MDD as defined in the DSM-IV-TR, and assessed by the MINI.
  • Current or history of: manic or hypomanic episode, schizophrenia  or any other psychotic disorder,  including schizoaffective  disorder, major depression with psychotic features,  bipolar depression with psychotic features, obsessive compulsive disorder (OCD), mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
  • Current diagnosis or history of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) as defined in the DSM-IV-TR that has not been in full and sustained remission for at least 3 months from the day of screening (Subject must also have negative urine drug screen at Screening and Baseline 1.)
  • Presence or history of a clinically significant neurological disorder (including epilepsy) as determined by the investigator.
  • Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc.).
  • Any Axis II disorder as defined by DSM-IV-TR that might compromise the study.
  • The current depressive symptoms of the subject are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.
  • The subject has a history of lack of response to previous adequate treatment with vortioxetine for any MDD episode with adequate treatment considered to be known dose of vortioxetine in the approved recommended dose range for at least 6 weeks duration.
  • The subject has received electroconvulsive therapy, vagal nerve stimulation,or repetitive transcranial magnetic stimulation within 6 months prior to Screening.
  • The subject has started receiving formal cognitive or behavioral therapy, systematic psychotherapy within 30 days from screening or plans to initiate such therapy duringthe study (supportive therapy, marital therapy and bereavement counseling are allowed).
  • The subject has a significant risk of suicide according to the investigator's clinical judgment or has a score 5 on item 10 (suicidal thoughts) of the MADRS or has made a suicide attempt in the previous 6 months.
  • The subject has a clinically significant unstable illness,for example hepatic impairment or renal insufficiency, or a cardiovascular, pulmonary,gastrointestinal,endocrine,neurological, rheumatologic,immunologic,hematological,infectious, dermatological  disorder  or  metabolic disturbance .
  • The subject has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma .
  • The subject has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability,or efficacy.
State
New York

Multi-center randomized, double-blind, placebo-controlled, phase 4 study to evaluate 3 fixed doses (5, 10,and 20 mg oral tablets) of vortioxetine once daily in the prevention of relapse in adult subjects with major depressive disorder (MDD) who have responded to acute treatment with vortioxetine.

College-Aged Adults Face Less Mental Health Stigma

College-aged adults (age 18–25) have more accepting views of mental health care than other adults, but they still see challenges when it comes to accessing care, according to results of a nationwide poll. The survey was conducted online among more than 2,000 adults, including 198 age 18–25, by Harris Poll on behalf of Anxiety and Depression Association of America (ADAA) and two partnering organizations.

Triumph!

Chonda Pierce, comedianA depressed comedian found treatment and she triumphed over her depression. Discover what makes her say,  “Baloney!”

Treating Anxiety and Depression in the Transitional Years (Ages 18-25)

Anne Marie Albano, PhD, ABPP

Associate Professor of Clinical Psychology in Psychiatry
and
Director, Columbia University Clinic for Anxiety and Related Disorders
Columbia University Medical Center

Co-Clinical Director, Youth Anxiety Center
New York-Presbyterian Hospital

Dr. Albano describes the so-called transitional years, or emerging adults ages 18 to 25, and what makes this a unique group when it comes to treating anxiety, OCD, and depression.