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
Associated Therapies
-

Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder

Phase 3
Completed
Conditions
Major Depressive Disorder
First Posted Date
2006-07-13
Last Posted Date
2011-01-26
Lead Sponsor
AstraZeneca
Target Recruit Count
494
Registration Number
NCT00351910
Locations
🇸🇪

Research Site, Uppsala, Sweden

PET (Positron Emission Tomography)/Public Speaking Study With A Combination Of 2 Medications In Social Anxiety Patients

Phase 2
Completed
Conditions
Depressive Disorder and Anxiety Disorders
First Posted Date
2006-06-23
Last Posted Date
2016-09-15
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
72
Registration Number
NCT00343707
Locations
🇸🇪

GSK Investigational Site, Uppsala, Sweden

Naltrexone & SSRI in Alcoholics With Depression/PTSD

Phase 3
Completed
Conditions
Alcoholism
Depression
PTSD
Interventions
First Posted Date
2006-06-20
Last Posted Date
2016-02-05
Lead Sponsor
Yale University
Target Recruit Count
88
Registration Number
NCT00338962
Locations
🇺🇸

VA Connecticut Healthcare Systems, West Haven, Connecticut, United States

Study Evaluating the Effects of DVS SR and Paroxetine on the Pharmacokinetics of Desipramine in Healthy Subjects

Phase 3
Completed
Conditions
Depression
First Posted Date
2006-05-24
Last Posted Date
2007-12-07
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
20
Registration Number
NCT00329147

Efficacy and Safety Study of Seroquel SR in the Treatment of Generalized Anxiety Disorder

Phase 3
Completed
Conditions
Generalized Anxiety Disorder
First Posted Date
2006-05-08
Last Posted Date
2008-12-22
Lead Sponsor
AstraZeneca
Target Recruit Count
800
Registration Number
NCT00322595
Locations
🇸🇪

Research Site, Uppsala, Sweden

Neuropathic Pain Assessment Comparing Pregabalin and Paroxetine in Management of MS-induced Neuropathic Pain

Phase 3
Completed
Conditions
Neuropathic Pain
Multiple Sclerosis
Interventions
First Posted Date
2006-02-13
Last Posted Date
2012-07-27
Lead Sponsor
University of Manitoba
Target Recruit Count
75
Registration Number
NCT00291148
Locations
🇨🇦

Multiple Sclerosis Clinic, Health Sciences Centre, Winnipeg, Manitoba, Canada

A Study Of A New Medicine (GW679769) For The Treatment Of Social Anxiety Disorder

Phase 2
Completed
Conditions
Anxiety Disorders
Social Anxiety Disorder
First Posted Date
2006-01-09
Last Posted Date
2016-10-26
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
242
Registration Number
NCT00273039
Locations
🇲🇽

GSK Investigational Site, Mexico, D.F., Mexico

Prazosin vs. Paroxetine in Combat Stress Symptoms in OIF/OEF Returnees

Not Applicable
Completed
Conditions
Sleep Disorders
Stress Disorders, Post-Traumatic
Interventions
First Posted Date
2005-12-05
Last Posted Date
2009-12-03
Lead Sponsor
US Department of Veterans Affairs
Target Recruit Count
210
Registration Number
NCT00261729
Locations
🇺🇸

VA Puget Sound Health Care System, Seattle, Seattle, Washington, United States

Combination Of PAXIL Tablet And Benzodiazepines

Phase 4
Completed
Conditions
Mental Disorders
Interventions
First Posted Date
2005-12-01
Last Posted Date
2017-01-18
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
150
Registration Number
NCT00259883
Locations

GSK Investigational Site

Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism

Phase 4
Completed
Conditions
Social Phobia
Alcohol Use Disorder
Alcohol Abuse
Social Anxiety Disorder
Alcohol Dependence
Interventions
Drug: Placebo
Drug: Paroxetine
First Posted Date
2005-10-30
Last Posted Date
2018-09-27
Lead Sponsor
Medical University of South Carolina
Target Recruit Count
42
Registration Number
NCT00246441
Locations
🇺🇸

Medical University of South Carolina, Institute of Psychiatry, Charleston, South Carolina, United States

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