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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

Food 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
NCT00647881
Locations
🇺🇸

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

Early Intervention for Post Traumatic Stress Disorder (PTSD)

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Withdrawn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

An Eight-week Study of Saredutant and Paroxetine as Combination Treatment for Major Depressive Disorder

Phase 3
Completed
Conditions
Depressive Disorder, Major
Interventions
First Posted Date
2008-03-06
Last Posted Date
2016-05-26
Lead Sponsor
Sanofi
Target Recruit Count
825
Registration Number
NCT00629551
Locations
🇿🇦

Sanofi-Aventis Administrative Office, Midrand, South Africa

Luteal Phase Administration of Paroxetine for the Treatment of PMDD

Phase 3
Completed
Conditions
Premenstrual Dysphoric Disorder
Interventions
First Posted Date
2008-02-21
Last Posted Date
2008-02-21
Lead Sponsor
Hamilton Health Sciences Corporation
Registration Number
NCT00620581
Locations
🇨🇦

Women's Health Concerns Clinic, Hamilton, Ontario, Canada

Paroxetine-CR (Paxil-CR) in the Treatment of Patients With Fibromyalgia Syndrome

Phase 4
Completed
Conditions
Fibromyalgia Syndrome
Interventions
Drug: Placebo
First Posted Date
2008-02-08
Last Posted Date
2013-06-20
Lead Sponsor
Duke University
Target Recruit Count
120
Registration Number
NCT00610610
Locations
🇺🇸

Duke University Medical Center, Durham, North Carolina, United States

🇺🇸

Thomas Jefferson University, Philadelphia, Pennsylvania, United States

Paroxetine - Controlled Release in the Treatment of Irritable Bowel Syndrome (IBS)

Phase 4
Completed
Conditions
Irritable Bowel Syndrome
Interventions
Drug: Placebo
First Posted Date
2008-02-08
Last Posted Date
2013-06-20
Lead Sponsor
Duke University
Target Recruit Count
60
Registration Number
NCT00610909
Locations
🇺🇸

Department of Psychiatry Clinical Trial Team, Duke University, Durham, North Carolina, United States

Dementia Antipsychotics And Antidepressants Discontinuation Study

First Posted Date
2008-01-15
Last Posted Date
2011-02-23
Lead Sponsor
Sykehuset Innlandet HF
Target Recruit Count
149
Registration Number
NCT00594269
Locations
🇳🇴

Sykehuset Innlandet HF, Reinsvoll, Oppland, Norway

🇳🇴

Diakonihjemmets Hospital, Oslo, Norway

🇳🇴

Ullevaal University Hospital, Oslo, Norway

and more 5 locations

Secondary Prevention With Paroxetine vs. Placebo in Subthreshold Posttraumatic Stress Disorder (PTSD)

Phase 4
Completed
Conditions
Stress Disorders, Post-Traumatic
Interventions
Drug: Placebo
First Posted Date
2007-11-20
Last Posted Date
2019-06-18
Lead Sponsor
Durham VA Medical Center
Target Recruit Count
12
Registration Number
NCT00560612
Locations
🇺🇸

Durham VAMC, Durham, North Carolina, United States

Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder (PTSD)

Phase 2
Terminated
Conditions
Post-Traumatic Stress Disorder
Stress Disorders, Post-Traumatic
Interventions
Other: placebo
First Posted Date
2007-11-14
Last Posted Date
2020-11-30
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
5
Registration Number
NCT00557622
Locations
🇯🇵

GSK Investigational Site, Tokyo, Japan

Paroxetine vs Placebo Combined With Aerobic Exercise or Relaxation in Panic Disorder

Phase 4
Completed
Conditions
Panic Disorder
Interventions
Drug: Placebo + aerobic exercise
Drug: Placebo + relaxation
First Posted Date
2007-10-05
Last Posted Date
2007-10-05
Lead Sponsor
University of Göttingen
Target Recruit Count
75
Registration Number
NCT00540098
Locations
🇩🇪

University of Göttingen, Dept of Psychiatry and Psychotherapy, Göttingen, Germany

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