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

Fixed Dose Study of PD 0332334 and Paroxetine for the Treatment of Generalized Anxiety Disorder

Phase 3
Terminated
Conditions
Anxiety Disorders
Interventions
First Posted Date
2009-02-04
Last Posted Date
2019-08-21
Lead Sponsor
Cedars-Sinai Medical Center
Target Recruit Count
5
Registration Number
NCT00836069
Locations
🇺🇸

Cedars-Sinai Medical Center Department of Psychiatry and Behavioral Neurosciences, Los Angeles, California, United States

Efficacy and Safety of SR58611 Compared to Placebo and Paroxetine

Phase 3
Completed
Conditions
Major Depressive Disorders
Interventions
First Posted Date
2009-01-19
Last Posted Date
2009-03-25
Lead Sponsor
Sanofi
Target Recruit Count
317
Registration Number
NCT00825058
Locations
🇷🇸

Sanofi-Aventis Administrative Office, Belgrade, Serbia

Efficacy and Safety of One Single Dose of SR58611 Compared to Placebo and Paroxetine

Phase 3
Completed
Conditions
Major Depressive Disorders
Interventions
First Posted Date
2009-01-19
Last Posted Date
2009-03-25
Lead Sponsor
Sanofi
Target Recruit Count
306
Registration Number
NCT00825019
Locations
🇺🇸

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

Paxil Japanese Post Marketing Paediatric Study in Depression (Double-blind, Placebo Controlled Study)

First Posted Date
2008-12-22
Last Posted Date
2017-01-13
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
56
Registration Number
NCT00812812
Locations
🇯🇵

GSK Investigational Site, Tokyo, Japan

Paroxetines Effect on Tramadols Metabolism and Pharmakodynamics: a Dose Response Study

Phase 4
Conditions
Depression
Pain
First Posted Date
2008-11-05
Last Posted Date
2009-02-13
Lead Sponsor
University of Southern Denmark
Target Recruit Count
12
Registration Number
NCT00785603

Changes of Cerebral Glucose Metabolism After 12 Weeks of Paroxetine Treatment in Panic Disorder

Phase 4
Completed
Conditions
Panic Disorder
Interventions
First Posted Date
2008-10-07
Last Posted Date
2011-07-25
Lead Sponsor
Samsung Medical Center
Target Recruit Count
37
Registration Number
NCT00767754
Locations
🇰🇷

Samsung Medical Center, Seoul, Korea, Republic of

PAXIL CR Bioequivalence Study

Phase 1
Completed
Conditions
Depressive Disorder
Interventions
First Posted Date
2008-09-09
Last Posted Date
2017-08-04
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
166
Registration Number
NCT00749359
Locations
🇺🇸

GSK Investigational Site, Tacoma, Washington, United States

Treatment of Panic Disorder Among Individuals Consulting Emergency Departments for Non Cardiac Chest Pain

Not Applicable
Conditions
Panic Disorder
Anxiety Disorder
Mental Disorder
Interventions
Behavioral: Brief cognitive-behavioral treatment for Panic Disorder
Behavioral: Cognitive-Behavior Therapy for Panic Disorder
First Posted Date
2008-08-15
Last Posted Date
2008-08-15
Lead Sponsor
Université du Québec a Montréal
Target Recruit Count
204
Registration Number
NCT00736346
Locations
🇨🇦

Hôpital du Sacré-Coeur de Montréal, Montréal, Quebec, Canada

🇨🇦

Hôtel-Dieu de Lévis, Lévis, Quebec, Canada

🇨🇦

Institut de Cardiologie de Montréal (Montreal Heart Institute), Montréal, Quebec, Canada

Clinical Study Assessing a New Scale to Measure Onset of Action in Generalized Anxiety Disorder

Not Applicable
Completed
Conditions
Anxiety Disorders
Interventions
First Posted Date
2008-07-15
Last Posted Date
2008-10-03
Lead Sponsor
Pfizer
Target Recruit Count
169
Registration Number
NCT00715039
Locations
🇺🇸

Pfizer Investigational Site, Cincinnati, Ohio, United States

Brain Markers of Treatment Response in Post-Traumatic Stress Disorder (PTSD)

Phase 4
Completed
Conditions
Post-traumatic Stress Disorder
Interventions
First Posted Date
2008-06-19
Last Posted Date
2014-06-03
Lead Sponsor
US Department of Veterans Affairs
Target Recruit Count
65
Registration Number
NCT00700999
Locations
🇺🇸

Jesse Brown VA Medical Center Community-Based Outpatient Clinic Lake Side Divison, Chicago, IL, Chicago, Illinois, United States

🇺🇸

VA Ann Arbor Healthcare System, Ann Arbor, MI, Ann Arbor, Michigan, United States

🇺🇸

Jesse Brown VA Medical Center, Chicago, IL, Chicago, Illinois, United States

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