WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older
[see Warnings and Precautions ].
In patients of all ages who are started on antidepressant therapy, monitor closely for clinical worsening and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber
[see Warnings and Precautions].
VIIBRYD is not approved for use in pediatric patients
[see Use in Specific Populations].
|
|
VIIBRYD SUMMARY
VIIBRYD Tablets for oral administration contain polymorph Form IV vilazodone hydrochloride (HCl), a selective serotonin reuptake inhibitor and a 5HT1A receptor partial agonist.
VIIBRYD is indicated for the treatment of major depressive disorder (MDD). The efficacy of VIIBRYD was established in two 8-week, randomized, double-blind, placebo-controlled trials in adult patients with a diagnosis of MDD [see Clinical Studies].
Major depressive disorder consists of one or more major depressive episodes. A major depressive episode (DSM-IV-TR) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation.
|
|
NEWS HIGHLIGHTS
Published Studies Related to Viibryd (Vilazodone)
Efficacy of vilazodone on anxiety symptoms in patients with major depressive
disorder. [2014] Anxiety symptoms are prevalent in patients with major depressive disorder. A
post-hoc analysis of two phase III trials was conducted to evaluate the efficacy
of vilazodone on depression-related anxiety... Vilazodone may be effective in treating patients with
major depressive disorder who exhibit somatic and/or psychic symptoms of anxiety.
An evaluation of sexual functioning in employed outpatients with major depressive
disorder treated with desvenlafaxine 50 mg or placebo. [2013] CONCLUSION: With the exception of orgasmic dysfunction in men without preexisting
A randomized, double-blind, placebo-controlled, 8-week study of vilazodone, a
serotonergic agent for the treatment of major depressive disorder. [2011] CONCLUSIONS: Vilazodone 40 mg/d was well tolerated and effective in adult
Evidence for efficacy and tolerability of vilazodone in the treatment of major
depressive disorder: a randomized, double-blind, placebo-controlled trial. [2009] CONCLUSIONS: Vilazodone is effective for the treatment of MDD in adults, with
A review of current evidence for vilazodone in major depressive disorder. [2013] on its differential action mechanism and extended clinical utility... CONCLUSION: Vilazodone is a newer antidepressant possessing different action
Clinical Trials Related to Viibryd (Vilazodone)
Safety and Efficacy of Vilazodone in Major Depressive Disorder [Completed]
Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder [Recruiting]
The purpose of this study is to evaluate the efficacy, safety, and tolerability of
vilazodone relative to placebo in adolescent outpatients (12-17) with major depressive
disorder.
Study to Evaluate the Sexual Functioning of Healthy Adults After Receiving Vilazodone, Paroxetine or Placebo [Completed]
Safety and Efficacy of Vilazodone in Major Depressive Disorder [Completed]
The purpose of this study was to evaluate the efficacy, safety, and tolerability of 2 fixed
dose levels of vilazodone compared to placebo in patients with major depressive disorder.
Vilazodone for Treatment of Geriatric Depression [Recruiting]
Reports of Suspected Viibryd (Vilazodone) Side Effects
Diarrhoea (133),
Nausea (120),
Insomnia (107),
Suicidal Ideation (96),
Headache (66),
Dizziness (58),
Hallucination (58),
Anxiety (58),
Depression (56),
Paraesthesia (54), more >>
|
|
Page last updated: 2015-08-10
|