MedPath

Paroxetine

Generic Name
Paroxetine
Brand Names
Paxil, Pexeva
Drug Type
Small Molecule
Chemical Formula
C19H20FNO3
CAS Number
61869-08-7
Unique Ingredient Identifier
41VRH5220H
Background

Paroxetine is a selective serotonin reuptake inhibitor (SSRI) drug commonly known as Paxil. It has a variety of uses, including the treatment of anxiety disorders, major depression, posttraumatic stress disorder, and symptoms of menopause, among others. It was approved by the FDA in the early 1990s and marketed by SmithKline Beecham. A unique feature of this drug is that it is highly potent and selective in its inhibition of serotonin reuptake and has little effect on other neurotransmitters. Because of its potent inhibition of serotonin reuptake, paroxetine is more likely to cause withdrawal effects upon cessation. Paroxetine is well tolerated in most patients with a similar adverse effect profile to other members of its drug class. The controlled release formulation was designed to decrease the likelihood of nausea that is sometimes associated with paroxetine.

Indication

Paroxetine is indicated for the management of depression, obsessive-compulsive disorder, panic disorder, social anxiety disorder, generalized anxiety disorder, posttraumatic stress disorder. One form of paroxetine, commercially known as Brisdelle, is used to manage mild to moderate vasomotor symptoms of menopause. Off-label, paroxetine may be used for the treatment of premature ejaculation or irritable bowel syndrome (IBS).

Associated Conditions
Generalized Anxiety Disorder, Irritable Bowel Syndrome (IBS), Major Depressive Disorder (MDD), Obsessive Compulsive Disorder (OCD), Panic Disorder, Post Traumatic Stress Disorder (PTSD), Premature Ejaculation, Premenstrual Dysphoric Disorder (PMDD), Social Anxiety Disorder (SAD), Vasomotor Symptoms Associated With Menopause

Serotonin-norepinephrine Reuptake Inhibitors and Acute Kidney Injury

First Posted Date
2014-12-19
Last Posted Date
2016-03-14
Lead Sponsor
Canadian Network for Observational Drug Effect Studies, CNODES
Target Recruit Count
3255526
Registration Number
NCT02320240
Locations
🇨🇦

Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada

Efficacy of Vortioxetine on Cognitive Dysfunction in Working Patients With Major Depressive Disorder

Phase 3
Completed
Conditions
Major Depressive Disorder
Interventions
First Posted Date
2014-10-31
Last Posted Date
2017-02-28
Lead Sponsor
H. Lundbeck A/S
Target Recruit Count
152
Registration Number
NCT02279966
Locations
🇫🇮

FI003, Helsinki, Finland

🇱🇹

LT005, Vilnius, Lithuania

🇪🇪

EE001, Tallinn, Estonia

and more 15 locations

Randomized,Controlled and Open-label Study of Buspirone add-on Treatment in Patients With Major Depression Disorder

Phase 4
Conditions
Major Depression Disorder
Interventions
First Posted Date
2014-10-23
Last Posted Date
2014-10-23
Lead Sponsor
Si Tianmei
Target Recruit Count
240
Registration Number
NCT02273154
Locations
🇨🇳

Henan mental health center, Xinxiang, Henan, China

🇨🇳

Institute of mental health, Peking University, Beijing, Beijing, China

🇨🇳

Wuhan mental health center, Wuhan, Hubei, China

and more 3 locations

Study to Investigate the Effect of Paroxetine Mediated CYP2D6 Inhibition on the Pharmacokinetics of Tamsulosin in Healthy Male Volunteers

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2014-10-15
Last Posted Date
2014-10-15
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
24
Registration Number
NCT02264184

Optimizing Antidepressant Treatment by Genotype-dependent Adjustment of Medication According to the ABCB1 Gene

First Posted Date
2014-09-12
Last Posted Date
2014-09-12
Lead Sponsor
HolsboerMaschmeyer NeuroChemie GmbH
Target Recruit Count
80
Registration Number
NCT02237937
Locations
🇩🇪

Max Planck Institute of Psychiatry, Munich, Bavaria, Germany

The Measurement-based Care in Patients With Depressive Disorder: A Randomized Controlled Trial

Phase 4
Completed
Conditions
Major Depressive Disorder
Interventions
First Posted Date
2014-07-16
Last Posted Date
2014-07-16
Lead Sponsor
Capital Medical University
Target Recruit Count
164
Registration Number
NCT02191124
Locations
🇨🇳

Beijing Anding Hospital, Beijing, Beijing, China

A Phase 1, Drug Interaction Study Between AVP-786 and Paroxetine and Between AVP-786 and Duloxetine in Healthy Subjects

Phase 1
Completed
Conditions
Drug-drug Interaction
Interventions
First Posted Date
2014-06-26
Last Posted Date
2022-02-18
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
56
Registration Number
NCT02174822
Locations
🇦🇺

Nucleus Network, Melbourne, Victoria, Australia

Study to Evaluate the Sexual Functioning of Healthy Adults After Receiving Vilazodone, Paroxetine or Placebo

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2014-03-26
Last Posted Date
2015-02-12
Lead Sponsor
Forest Laboratories
Target Recruit Count
202
Registration Number
NCT02097147
Locations
🇺🇸

Forest Investigative Site 001, Miami, Florida, United States

🇺🇸

Forest Investigative Site 002, Overland Park, Kansas, United States

🇺🇸

Forest Investigative Site 004, Charlottesville, Virginia, United States

and more 1 locations

Efficacy of Exposure and Response Prevention(ERP) and SSRIs in Chinese OCD Patients

Phase 4
Completed
Conditions
Obsessive-Compulsive Disorder
Anxiety Disorders
Mental Disorders
Interventions
First Posted Date
2013-12-30
Last Posted Date
2022-09-09
Lead Sponsor
Shanghai Mental Health Center
Target Recruit Count
78
Registration Number
NCT02022709
Locations
🇨🇳

Shanghai Mental Health Center, Shanghai, Shanghai, China

Efficacy and Safety of Paroxetine Controlled Release for Major Depressive Disorder in Irritable Bowel Syndrome Patients

Phase 4
Withdrawn
Conditions
Depressive Disorder
Interventions
First Posted Date
2013-08-05
Last Posted Date
2014-07-16
Lead Sponsor
GlaxoSmithKline
Registration Number
NCT01916200
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