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

Paroxetine/Bupropion in Suicide Attempters/Ideators With Major Depression

Phase 4
Terminated
Conditions
Depression
Interventions
First Posted Date
2007-01-31
Last Posted Date
2018-10-30
Lead Sponsor
New York State Psychiatric Institute
Target Recruit Count
101
Registration Number
NCT00429169
Locations
🇺🇸

Columbia University/New York State Psychiatric Institute, New York, New York, United States

MDD POC Study GSK372475 Subjects Depressive Disease

Phase 2
Completed
Conditions
Depressive Disorder
Interventions
First Posted Date
2007-01-11
Last Posted Date
2018-02-05
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
492
Registration Number
NCT00420641
Locations
🇵🇱

GSK Investigational Site, Leszno, Poland

Single Dose Pharmacokinetic (PK) Study Of Paroxetine CR(12.5-37.5mg) In Healthy Chinese Subjects

Phase 1
Completed
Conditions
Depressive Disorder
Interventions
First Posted Date
2006-12-04
Last Posted Date
2017-09-29
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
6
Registration Number
NCT00406003
Locations
🇨🇳

GSK Investigational Site, Beijing, China

A Repeat Dose Pharmacokinetic Study Of Paroxetine CR Tablet In Healthy Chinese Subjects

Phase 1
Completed
Conditions
Depressive Disorder
Interventions
First Posted Date
2006-12-04
Last Posted Date
2017-09-29
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
12
Registration Number
NCT00406432
Locations
🇨🇳

GSK Investigational Site, Beijing, China

Monoamine Transporters Genotypes: Risk of PTSD and Related Comorbidities

Phase 3
Completed
Conditions
PTSD
Interventions
First Posted Date
2006-11-23
Last Posted Date
2018-07-02
Lead Sponsor
VA Office of Research and Development
Target Recruit Count
38
Registration Number
NCT00403455
Locations
🇺🇸

Ralph H. Johnson VA Medical Center, Charleston, SC, Charleston, South Carolina, United States

Lithium Versus Paroxetine in Patients With Major Depression Who Have a Family History of Bipolar Disorder or Suicide

Phase 3
Terminated
Conditions
Major Depressive Disorder
Interventions
First Posted Date
2006-11-16
Last Posted Date
2021-01-29
Lead Sponsor
Nova Scotia Health Authority
Target Recruit Count
2
Registration Number
NCT00400088
Locations
🇨🇦

Capital District Health Authority - Dept. of Psychiatry, Halifax, Nova Scotia, Canada

Treatment Of Patients With Social Anxiety Disorder

Phase 2
Completed
Conditions
Social Phobia
First Posted Date
2006-11-09
Last Posted Date
2017-07-11
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
299
Registration Number
NCT00397722
Locations
🇸🇪

GSK Investigational Site, Uppsala, Sweden

SSRI Effects on Semen Parameters in Men

Completed
Conditions
Healthy
First Posted Date
2006-10-11
Last Posted Date
2017-08-02
Lead Sponsor
Weill Medical College of Cornell University
Target Recruit Count
35
Registration Number
NCT00385762
Locations
🇺🇸

Department of Urology, Weill Medical College of Cornell University, New York, New York, United States

Clinical Pharmacogenomics of Antidepressant Response

Completed
Conditions
Depression
First Posted Date
2006-10-04
Last Posted Date
2010-02-01
Lead Sponsor
National Health Research Institutes, Taiwan
Target Recruit Count
402
Registration Number
NCT00384020
Locations
🇨🇳

Mackay Memorial Hospital, Taipei, Taiwan

🇨🇳

Song-De Branch, Taipei City Hospital, Taipei, Taiwan

🇨🇳

Chang Gung Memorial Hospital, Taoyuan, Taiwan

and more 1 locations

An Eight-week Study Evaluating the Efficacy and Tolerability of Two Doses of SSR149415 in Outpatients With Generalized Anxiety Disorder

Phase 2
Completed
Conditions
Anxiety Disorders
Interventions
First Posted Date
2006-09-08
Last Posted Date
2016-05-25
Lead Sponsor
Sanofi
Target Recruit Count
325
Registration Number
NCT00374166
Locations
🇺🇸

Sanofi-Aventis Administrative Office, Bridgewater, New Jersey, United States

© Copyright 2025. All Rights Reserved by MedPath