Paroxetine Mesylate

Premature Ejaculation, Panic Disorder, Social Anxiety Disorder + 7 more

Treatment

3 FDA approvals

20 Active Studies for Paroxetine Mesylate

What is Paroxetine Mesylate

Paroxetine

The Generic name of this drug

Treatment Summary

Paroxetine, also known as Paxil, is a medication used to treat anxiety disorders, depression, post-traumatic stress disorder and menopause symptoms. It was approved by the FDA in the early 1990s and is more potent and selective than other serotonin reuptake inhibitors. Paroxetine may cause withdrawal symptoms when stopped, and has a similar side effect profile to other SSRIs. The controlled release formulation helps decrease nausea which can sometimes be associated with paroxetine.

Paxil

is the brand name

image of different drug pills on a surface

Paroxetine Mesylate Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Paxil

Paroxetine

1993

429

Approved as Treatment by the FDA

Paroxetine, also known as Paxil, is approved by the FDA for 3 uses which include Vasomotor Symptoms Associated With Menopause and Hot Flashes .

Vasomotor Symptoms Associated With Menopause

Helps manage Vasomotor Symptoms Associated With Menopause

Hot Flashes

Helps manage Vasomotor Symptoms Associated With Menopause

Hot flashes

Helps manage Menopause

Effectiveness

How Paroxetine Mesylate Affects Patients

Paroxetine is a medication used to treat depression, anxiety disorders, posttraumatic stress disorder, obsessive-compulsive disorder, and menopause-related symptoms. It works by blocking the reuptake of serotonin. It usually takes about 6 weeks for Paroxetine to start working. When taken with certain other drugs (monoamine oxidase inhibitors), it can cause a dangerous reaction called serotonin syndrome, so it is important to wait at least two weeks after stopping the other drug before taking Paroxetine.

How Paroxetine Mesylate works in the body

Paroxetine works by blocking the reuptake of serotonin, a chemical in the brain. This increases the amount of serotonin in the body, which helps to relieve symptoms. Paroxetine is more potent than other drugs in its class, like citalopram, fluoxetine, and fluvoxamine. The exact way it helps relieve symptoms of menopause is not known, but it may work by affecting temperature regulation. Paroxetine also binds to other receptors, including adrenergic alpha-1 and alpha-2 receptors and serotonin 5-HT1A, 5-HT2A, and 5

When to interrupt dosage

The quantity of Paroxetine Mesylate is dependent upon the diagnosed condition, including Post Traumatic Stress Disorder, Depression and Irritable Bowel Syndrome (IBS). The amount of dosage also is contingent upon the mode of delivery (e.g. Oral or Capsule - Oral) detailed in the table underneath.

Condition

Dosage

Administration

Generalized Anxiety Disorder

, 10.0 mg, 20.0 mg, 30.0 mg, 40.0 mg, 12.5 mg, 25.0 mg, 37.5 mg, 7.5 mg, 10.0 mg/mL, 2.0 mg/mL

, Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Suspension, Suspension - Oral, Tablet, extended release - Oral, Tablet, extended release

Irritable Bowel Syndrome

, 10.0 mg, 20.0 mg, 30.0 mg, 40.0 mg, 12.5 mg, 25.0 mg, 37.5 mg, 7.5 mg, 10.0 mg/mL, 2.0 mg/mL

, Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Suspension, Suspension - Oral, Tablet, extended release - Oral, Tablet, extended release

Depression

, 10.0 mg, 20.0 mg, 30.0 mg, 40.0 mg, 12.5 mg, 25.0 mg, 37.5 mg, 7.5 mg, 10.0 mg/mL, 2.0 mg/mL

, Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Suspension, Suspension - Oral, Tablet, extended release - Oral, Tablet, extended release

Hot Flashes

, 10.0 mg, 20.0 mg, 30.0 mg, 40.0 mg, 12.5 mg, 25.0 mg, 37.5 mg, 7.5 mg, 10.0 mg/mL, 2.0 mg/mL

, Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Suspension, Suspension - Oral, Tablet, extended release - Oral, Tablet, extended release

Premature Ejaculation

, 10.0 mg, 20.0 mg, 30.0 mg, 40.0 mg, 12.5 mg, 25.0 mg, 37.5 mg, 7.5 mg, 10.0 mg/mL, 2.0 mg/mL

, Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Suspension, Suspension - Oral, Tablet, extended release - Oral, Tablet, extended release

Panic Disorder

, 10.0 mg, 20.0 mg, 30.0 mg, 40.0 mg, 12.5 mg, 25.0 mg, 37.5 mg, 7.5 mg, 10.0 mg/mL, 2.0 mg/mL

, Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Suspension, Suspension - Oral, Tablet, extended release - Oral, Tablet, extended release

Social Anxiety Disorder

, 10.0 mg, 20.0 mg, 30.0 mg, 40.0 mg, 12.5 mg, 25.0 mg, 37.5 mg, 7.5 mg, 10.0 mg/mL, 2.0 mg/mL

, Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Suspension, Suspension - Oral, Tablet, extended release - Oral, Tablet, extended release

Obsessive-Compulsive Disorder

, 10.0 mg, 20.0 mg, 30.0 mg, 40.0 mg, 12.5 mg, 25.0 mg, 37.5 mg, 7.5 mg, 10.0 mg/mL, 2.0 mg/mL

, Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Suspension, Suspension - Oral, Tablet, extended release - Oral, Tablet, extended release

Hot flashes

, 10.0 mg, 20.0 mg, 30.0 mg, 40.0 mg, 12.5 mg, 25.0 mg, 37.5 mg, 7.5 mg, 10.0 mg/mL, 2.0 mg/mL

, Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Suspension, Suspension - Oral, Tablet, extended release - Oral, Tablet, extended release

Post Traumatic Stress Disorder

, 10.0 mg, 20.0 mg, 30.0 mg, 40.0 mg, 12.5 mg, 25.0 mg, 37.5 mg, 7.5 mg, 10.0 mg/mL, 2.0 mg/mL

, Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Suspension, Suspension - Oral, Tablet, extended release - Oral, Tablet, extended release

Warnings

Paroxetine Mesylate has five contraindications and is not to be taken if any of the conditions in the following table are present.

Paroxetine Mesylate Contraindications

Condition

Risk Level

Notes

Pulse Frequency

Do Not Combine

Pulse Frequency

Do Not Combine

Serotonin Syndrome

Do Not Combine

Pulse Frequency

Do Not Combine

Severe Hypersensitivity Reactions

Do Not Combine

Paroxetine may interact with Pulse Frequency

There are 20 known major drug interactions with Paroxetine Mesylate.

Common Paroxetine Mesylate Drug Interactions

Drug Name

Risk Level

Description

4-Methoxyamphetamine

Major

The metabolism of 4-Methoxyamphetamine can be decreased when combined with Paroxetine.

5-methoxy-N,N-dimethyltryptamine

Major

The metabolism of 5-methoxy-N,N-dimethyltryptamine can be decreased when combined with Paroxetine.

Acebutolol

Major

The metabolism of Acebutolol can be decreased when combined with Paroxetine.

Acetaminophen

Major

The metabolism of Acetaminophen can be decreased when combined with Paroxetine.

Aclidinium

Major

The risk or severity of adverse effects can be increased when Paroxetine is combined with Aclidinium.

Paroxetine Mesylate Toxicity & Overdose Risk

The toxic dose of paroxetine in mice and rats has been found to be 350 mg/kg. The lowest reported fatal overdose of paroxetine is 400 mg, while the highest reported survived overdose is 2000 mg. Symptoms of paroxetine overdose can include fatigue, fever, high blood pressure, rapid heartbeat, nausea, vomiting, drowsiness, trembling, dizziness, agitation, confusion, anxiety, headache, sweating, dilated pupils, seizures, tingling sensations, serotonin syndrome, and changes in mental status. There is no antidote to an overdose of paroxetine.

image of a doctor in a lab doing drug, clinical research

Paroxetine Mesylate Novel Uses: Which Conditions Have a Clinical Trial Featuring Paroxetine Mesylate?

539 active studies are currently assessing the potential of Paroxetine Mesylate to alleviate Post Traumatic Stress Disorder, Premature Ejaculation and Menopausal symptoms.

Condition

Clinical Trials

Trial Phases

Social Anxiety Disorder

16 Actively Recruiting

Not Applicable

Depression

215 Actively Recruiting

Phase 3, Phase 2, Not Applicable, Phase 4, Phase 1, Early Phase 1

Obsessive-Compulsive Disorder

66 Actively Recruiting

Not Applicable, Phase 2, Phase 3, Phase 1, Early Phase 1

Generalized Anxiety Disorder

7 Actively Recruiting

Not Applicable, Phase 2, Phase 3

Post Traumatic Stress Disorder

242 Actively Recruiting

Not Applicable, Early Phase 1, Phase 3, Phase 4, Phase 2, Phase 1

Panic Disorder

14 Actively Recruiting

Not Applicable

Irritable Bowel Syndrome

6 Actively Recruiting

Not Applicable, Phase 4, Phase 2, Early Phase 1

Hot Flashes

4 Actively Recruiting

Not Applicable, Phase 2, Phase 1

Premature Ejaculation

0 Actively Recruiting

Hot flashes

19 Actively Recruiting

Not Applicable, Phase 4, Phase 2, Early Phase 1, Phase 3

Paroxetine Mesylate Reviews: What are patients saying about Paroxetine Mesylate?

4.3

Patient Review

8/18/2014

Paroxetine Mesylate for Major Depressive Disorder

This medication unfortunately just makes me tired.

4

Patient Review

10/7/2016

Paroxetine Mesylate for Extreme Apprehension or Fear of Social Interaction

This medication helped me to effectively manage my panic attacks and social anxiety. I still experience these symptoms, but they are much less severe than before. It took about a week for the effects of this drug to be noticeable.

3.3

Patient Review

2/5/2008

Paroxetine Mesylate for Repeated Episodes of Anxiety

3.3

Patient Review

4/27/2009

Paroxetine Mesylate for Panic Disorder

3

Patient Review

3/15/2010

Paroxetine Mesylate for Osteoporosis

This medication helps me with my anxiety, for the most part. I still have occasional episodes where I get anxious, but it's manageable. As for sexual side effects, they happen often enough that it's become a bit of a nuisance.

2.7

Patient Review

2/25/2011

Paroxetine Mesylate for Repeated Episodes of Anxiety

I wasn't really blown away by this treatment. It was just okay in my opinion.

1

Patient Review

5/18/2015

Paroxetine Mesylate for Posttraumatic Stress Syndrome

I've been on this medication for two decades now. I saw an immediate change that has kept me satisfied for all these years. However, I have put on weight and lost interest in sex; because of these side effects, I'm thinking about changing to a different antidepressant.

Patient Q&A Section about paroxetine mesylate

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is paroxetine mesylate used for?

"Paroxetine is most commonly used to treat depression, panic attacks, OCD, and anxiety disorders by helping to restore the balance of serotonin in the brain. Paroxetine is classified as a selective serotonin reuptake inhibitor (SSRI), which is a type of drug that works by preventing serotonin from being reabsorbed by the brain."

Answered by AI

What is paroxetine mesylate 7.5 mg cap?

"There is now a nonhormonal option for the treatment of moderate to severe VMS associated with menopause that has been approved by the US Food and Drug Administration. Brisdelle (paroxetine 7.5 mg) is the first medication of its kind to receive this approval."

Answered by AI

Is paroxetine used for menopause?

"Paroxetine 7.5 mg is the only nonhormonal treatment that has been approved in the United States for moderate to severe vasomotor symptoms associated with menopause."

Answered by AI

Is paroxetine and paroxetine mesylate the same?

"The active ingredient in the generic and brand-name version of the drug paroxetine is the same, and the two versions of the drug have similar pharmacokinetic and pharmacodynamic properties."

Answered by AI

Clinical Trials for Paroxetine Mesylate

Image of University of Colorado Anschutz Medical Campus in Aurora, United States.

Senseye Diagnostic Tool for Post-Traumatic Stress Disorder

18+
All Sexes
Aurora, CO

The goal of the REVEAL PTSD study is to test how well the Senseye DT works as a diagnostic test for Post-traumatic Stress Disorder (PTSD) in adults 18 and older who are experiencing one or more symptoms that might be related to PTSD. The Senseye DT is software as a medical device (SaMD) and is an iPhone app that administers a series of simple tasks on the phone while recording video during the tasks through the front-facing camera. The videos are analyzed by a a Machine Learning (ML) algorithm to identify physiologic signals that might be indicative of PTSD. Data collected in this study will be used to train and tune the ML algorithm, then test it for accuracy. The main questions this study aims to answer are: 1. How accurate is the Senseye DT in detecting PTSD compared to structured clinical interviews, the current clinical standard for diagnostic testing? 2. How accurately does the Senseye DT predict PTSD severity? 3. How fast is the Senseye DT to use compared to structured clinical interviews? Participants will attend a virtual screening visit via video call to determine eligibility and consent to participate. Once enrolled, participants will attend 2 or 3 additional study visits: * Visit 1: A virtual visit where standard mental health assessments will be given by clinical raters trained in mental health and administering these structured clinical interviews. These assessments include the Structured Interview Guide for the Montgomery-Asburg Depression Rating Scale (SIGMA), the Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A), and the MINI International Neurodiagnostic Interview. The Clinician-Administered PTSD Scale for DSM-5 Revised Version (CAPS-5-R) may also be conducted, if randomly selected. * Visit 2: A visit to use the Senseye DT. For participants near one of the study's physical site locations, this visit will be done in person at the site. For all others, this visit will be conducted virtually. * Visit 3: For participants not randomly selected to have the CAPS-5-R administered at Visit 1, a third and final visit will be scheduled for this assessment. This visit will be conducted virtually. The total expected participation time for enrolled participants is 6-7 hours over the course of 2-3 weeks.

Phase 3
Waitlist Available

University of Colorado Anschutz Medical Campus (+3 Sites)

Senseye, Inc.

Image of University of Rochester Medical Center in Rochester, United States.

Deaf CBT-TS for Suicide Risk

18+
All Sexes
Rochester, NY

The goal of this clinical trial is to learn if a short, Zoom-based intervention, Cognitive Behavioral Therapy for Treatment-Seeking for Deaf Individuals (Deaf CBT-TS) can change beliefs about mental health treatment and increase treatment-seeking behaviors in Deaf adults with untreated mental health or alcohol use problems. It will also see if Deaf CBT-TS may reduce suicide risk and explore factors that may increase the effectiveness of Deaf CBT-TS. The main questions it aims to answer are: * Does Deaf CBT-TS increase positive beliefs about treatment and increase treatment-seeking behaviors? * Does Deaf CBT-TS increase hope and reduce mental health symptoms, suicide ideation, and alcohol use? * Is Deaf CBT-TS more effective for individuals with less cultural stress compared to those with high levels of cultural stress? * Is Deaf CBT-TS more effective for Deaf individuals in residential areas with more Deaf resources than those with less Deaf resources? Researchers will compare individuals who complete Deaf CBT-TS to those on a waitlist to see if Deaf CBT-TS works to increase positive beliefs about treatment and treatment-seeking behaviors. Participants will: * Complete a baseline assessment including demographic information, measures of hope, general mental health and functioning, alcohol use, suicide ideation, cultural stress, and beliefs about treatment. * Receive Deaf CBT-TS (2 sessions) or be placed on a waitlist with the option of receiving Deaf CBT-Ts after 4 months * Complete two follow-up assessments in 2 and 4 months.

Waitlist Available
Has No Placebo

University of Rochester Medical Center

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Psychotherapy for Depression

18 - 65
Female
Hamilton, Canada

The RESPOND trial explores the link between early life adversity and later life depressive symptoms. The investigators have designed a new psychological therapy tailored to address the symptoms that can be caused by difficult experiences in early life. These symptoms include low mood, emotional dysregulation, and distressing thoughts and beliefs related to difficult or traumatic experiences. The investigators would like to see if this new therapy helps people feel better. The investigators are also studying the biological changes that can occur as a result of early life adversity, and how this therapy may influence those changes. To do this, The investigators ask questions about participants' physical and mental health and take blood samples.

Recruiting
Has No Placebo

St. Joseph's Healthcare Hamilton

Sheryl Green, PhD

Image of Stanford Digestive Health Clinic in Redwood City, United States.

MITI-001 for Irritable Bowel Syndrome

18 - 65
All Sexes
Redwood City, CA

While the pathophysiology of diarrhea-predominant irritable bowel syndrome (IBS-D) is complex and heterogeneous, dysbiosis of the gut microbiome is frequently observed, suggesting that a substantial subset of patients with irritable bowel syndrome (IBS) have symptoms that are initiated and/or perpetuated by a microbiome dysfunction. Successful randomized controlled trials (RCT) for IBS-D (Ford 2018; Black 2022) leveraging microbiome-targeted therapies (antibiotics or low microbiome fermentation diets) suggest the gut microbiome is at least partially involved in IBS symptoms. Furthermore, fecal microbiota transplantation (FMT) for patients with IBS-D has demonstrated promising results (El-Salhy 2020), supporting the possibility that altering the microbiome composition could ameliorate IBS-D symptoms. MITI-001 is a transplantable gut bacterial community composed of 157 live bacterial strains, encompassing 79 genera of commensal bacteria, that have been isolated from healthy donor stool, purified, and banked. The hypothesis of the proposed research is that MITI-001 can target the pathophysiologic lesion in a subset of IBS-D patients, restore the altered microbial metabolic process, and thus alleviate IBS-D symptoms.

Phase < 1
Waitlist Available

Stanford Digestive Health Clinic (+1 Sites)

Sean P Spencer, MD, PhD

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Stepped Care Treatment for Anxiety

7 - 17
All Sexes
Houston, TX

Childhood anxiety disorders (CAD) are common and impairing. Family based cognitive behavioral therapy (CBT) is efficacious in treating CAD. Yet, many children do not receive care due to barriers such as limited provider availably, high treatment costs, and constrained family resources (e.g., time). To combat these barriers, other treatment methods have been developed. The stepped care treatment models maximize resources by providing low-intensity, low-cost interventions as a first time treatment, while stepping up care for those needing more intensive treatment. Specifically, a stepped care model for CAD that begins with a parent-focus intervention has great promise to deliver efficacious and cost-effective treatment without having to engage the child. While stepped care approaches show promise in treating CAD with comparable efficacy to standard CBT, there remains a large research-to-practice gap. The stepped care model for CAD that begins with a parent-focused intervention has yet been explored, and very little is known about intervention mediators that explain mechanisms of change. This research is being done to improve the reach and quality of services using a stepped care model, offering an affordable and practical solution to the widespread gap in youth mental health care.

Waitlist Available
Has No Placebo

Baylor College of Medicine

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Cognitive Rehabilitation for Anger in TBI and PTSD

18+
All Sexes
Durham, NC

This randomized clinical trial will enroll 100 Veteran-family/friend dyads to test the efficacy of CALM in treating anger in TBI and PTSD. The investigators hypothesize that compared to an active control group, Veterans randomized to the CALM group will demonstrate: * Significantly larger decreases in anger dysregulation, impulsivity, and executive dysfunction. * Significantly larger improvements in social and adaptive functioning including less aggression. * Significantly larger reduction in PTSD symptoms and suicidal ideation. The study targets Veterans who experience difficulties with anger and impulsivity due to TBI and PTSD. These issues are common, with up to 38% of Veterans with TBI also having PTSD. These conditions often make it challenging for Veterans to control their emotions and interact successfully in social and work settings. Our research will test the CALM (Cognitive Applications for Life Management) mobile app, which helps Veterans manage their goals, remember important tasks, and improve their attention. Initial tests of CALM have shown it can reduce levels of anger and related issues in Veterans. The investigators will conduct a study with 100 pairings of Veterans and a family member or friend. These pairs will be randomly assigned to one of two groups: one using the CALM mobile platform and the other receiving brain health education. Both groups will use their assigned intervention for three months and will receive support through videoconference calls at the beginning, middle, and end of the program.

Waitlist Available
Has No Placebo

Duke University School of Medicine

Eric Elbogen

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