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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
Associated Therapies
-

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

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: paroxetine
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
Drug: paroxetine
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
Drug: paroxetine
Drug: Placebo
Drug: PD 0332334
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
Drug: PD 0332334
Drug: Paroxetine
Drug: Placebo
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
Drug: Placebo
Drug: PD 0332334
Drug: Paroxetine
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

Early Intervention for Post Traumatic Stress Disorder (PTSD)

Not Applicable
Withdrawn
Conditions
Post-Traumatic Stress Disorders
Interventions
Drug: placebo
Drug: paroxetine
First Posted Date
2008-03-24
Last Posted Date
2015-06-26
Lead Sponsor
US Department of Veterans Affairs
Registration Number
NCT00641173
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