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

Special Drug Use Investigation for PAXIL Tablet (Investigation in Case of Administered From 20mg/Day)

Completed
Conditions
Panic Disorder
Interventions
First Posted Date
2011-06-10
Last Posted Date
2017-05-22
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
1483
Registration Number
NCT01371474

Special Drug Use Investigation for PAXIL Tablet (20mg-Clinical Symptom Progression)

Completed
Conditions
Mental Disorders
Interventions
First Posted Date
2011-06-10
Last Posted Date
2017-06-08
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
390
Registration Number
NCT01371461

Special Drug Use Investigation for PAXIL Tablet (Long-term)

Completed
Conditions
Mental Disorders
Interventions
First Posted Date
2011-06-10
Last Posted Date
2017-06-08
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
339
Registration Number
NCT01371448

Drug Use Investigation for PAXIL Tablet

Completed
Conditions
Mental Disorders
Interventions
First Posted Date
2011-06-10
Last Posted Date
2017-06-08
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
3708
Registration Number
NCT01371435

Effects of MNTX on CYP450 2D6 in Metabolizers of Dextromethorphan

Phase 1
Completed
Conditions
Healthy Adults
Interventions
First Posted Date
2011-06-07
Last Posted Date
2019-11-27
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
54
Registration Number
NCT01367535
Locations
🇺🇸

Progenics Pharmaceuticals, Tarrytown, New York, United States

Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial)

Phase 3
Completed
Conditions
Depression
Depressive Disorder, Major
Depressive Disorder
Mood Disorders
Mental Disorders
Interventions
First Posted Date
2011-05-26
Last Posted Date
2018-09-17
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
2944
Registration Number
NCT01360866
Locations
🇺🇦

Research Site, Poltava, Ukraine

Study of Paroxetine and Fluconazole for the Treatment of HIV Associated Neurocognitive Disorder

Phase 1
Completed
Conditions
HIV Associated Neurocognitive Disorder
Interventions
First Posted Date
2011-05-16
Last Posted Date
2017-06-09
Lead Sponsor
Johns Hopkins University
Target Recruit Count
45
Registration Number
NCT01354314
Locations
🇺🇸

The Johns Hopkins Institute for Clinical and Translational Research, Adult Outpatient Clinical Research Unit, Baltimore, Maryland, United States

Paxil CR Bioequivalence Study Brazil - Fed Administration

First Posted Date
2011-04-20
Last Posted Date
2018-06-20
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
60
Registration Number
NCT01339247
Locations
🇧🇷

GSK Investigational Site, Belo Horizonte, Minas Gerais, Brazil

Combination Treatment for Posttraumatic Stress Disorder (PTSD) After the World Trade Center (WTC) Attack

Phase 4
Completed
Conditions
Posttraumatic Stress Disorder
Interventions
Behavioral: Prolonged Exposure Therapy
First Posted Date
2010-05-25
Last Posted Date
2012-12-04
Lead Sponsor
Research Foundation for Mental Hygiene, Inc.
Target Recruit Count
37
Registration Number
NCT01130103
Locations
🇺🇸

New York State Psychiatric Institute, New York, New York, United States

Amitriptyline and Paroxetine Treatment of Major Depression

Phase 3
Completed
Conditions
Unipolar Depression
Interventions
First Posted Date
2010-01-14
Last Posted Date
2024-01-31
Lead Sponsor
Central Institute of Mental Health, Mannheim
Target Recruit Count
127
Registration Number
NCT01049347
Locations
🇩🇪

Central Institute of Mental Health, Mannheim, Germany

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