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

A Study Of Sertraline Compared With Paroxetine In The Treatment Of Panic Disorder

Phase 4
Completed
Conditions
Panic Disorder
Interventions
First Posted Date
2008-05-14
Last Posted Date
2021-01-27
Lead Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Target Recruit Count
321
Registration Number
NCT00677352
Locations
🇯🇵

Pfizer Investigational Site, Minato-ku, Japan

Effects of Paxil CR on Neural Circuits in Posttraumatic Stress Disorder (PTSD)

Phase 4
Completed
Conditions
Posttraumatic Stress Disorder (PTSD)
Interventions
Drug: placebo
First Posted Date
2008-05-06
Last Posted Date
2017-03-01
Lead Sponsor
Emory University
Target Recruit Count
40
Registration Number
NCT00672776

A Study Comparing Duloxetine to Other Antidepressants in the Treatment of Severe Depression

First Posted Date
2008-04-25
Last Posted Date
2010-06-15
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
750
Registration Number
NCT00666757
Locations
🇺🇸

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Brown Deer, Wisconsin, United States

Neural Correlates of Early Intervention for Posttraumatic Stress Disorder (PTSD)

Phase 4
Terminated
Conditions
Posttraumatic Stress Disorder (PTSD)
Interventions
Drug: placebo
First Posted Date
2008-04-24
Last Posted Date
2012-07-11
Lead Sponsor
Foundation for Atlanta Veterans Education and Research, Inc.
Target Recruit Count
160
Registration Number
NCT00665678
Locations
🇺🇸

Emory University, Atlanta, Georgia, United States

A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder (3)

Phase 3
Terminated
Conditions
Generalized Anxiety Disorder
Interventions
First Posted Date
2008-04-15
Last Posted Date
2012-11-16
Lead Sponsor
Pfizer
Target Recruit Count
286
Registration Number
NCT00658762
Locations
🇭🇺

Pfizer Investigational Site, Budapest, Hungary

A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 in Patients With Generalized Anxiety Disorder (2)

Phase 3
Terminated
Conditions
Generalized Anxiety Disorder
Interventions
First Posted Date
2008-04-15
Last Posted Date
2012-11-16
Lead Sponsor
Pfizer
Target Recruit Count
360
Registration Number
NCT00658372
Locations
🇨🇳

Pfizer Investigational Site, Tainan, Taiwan

A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 in Patients With Generalized Anxiety Disorder (1)

Phase 3
Terminated
Conditions
Generalized Anxiety Disorder
Interventions
First Posted Date
2008-04-14
Last Posted Date
2012-11-16
Lead Sponsor
Pfizer
Target Recruit Count
501
Registration Number
NCT00658008
Locations
🇷🇺

Pfizer Investigational Site, Khotkovo, Moscow region, Russian Federation

Food Study of Paroxetine Hydrochloride Tablets 40 mg and Paxil® Tablets 40 mg

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2008-04-01
Last Posted Date
2024-04-24
Lead Sponsor
Mylan Pharmaceuticals Inc
Target Recruit Count
66
Registration Number
NCT00650403
Locations
🇺🇸

Gateway Medical Research, Inc., Saint Charles, Missouri, United States

Fasting Study of Paroxetine Hydrochloride Controlled-Release Tablets 25 mg to Paxil CR™ Tablets 25 mg

First Posted Date
2008-04-01
Last Posted Date
2024-04-24
Lead Sponsor
Mylan Pharmaceuticals Inc
Target Recruit Count
75
Registration Number
NCT00648427
Locations
🇺🇸

PRACS Institute, Ltd., Fargo, North Dakota, United States

Fasting Study of Paroxetine Hydrochloride Tablets 40 mg and Paxil® Tablets 40 mg

Early Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2008-04-01
Last Posted Date
2024-04-24
Lead Sponsor
Mylan Pharmaceuticals Inc
Target Recruit Count
36
Registration Number
NCT00648193
Locations
🇺🇸

Gateway Medical Research, Inc., Saint Charles, Missouri, United States

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