Paroxetine Hydrochloride

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

Treatment

3 FDA approvals

20 Active Studies for Paroxetine Hydrochloride

What is Paroxetine Hydrochloride

Paroxetine

The Generic name of this drug

Treatment Summary

Paroxetine, also known as Paxil, is a drug used to treat a range of mental health issues including anxiety, depression, PTSD, and menopause symptoms. It was introduced in the 1990s and is more powerful than other SSRIs (selective serotonin reuptake inhibitors), meaning it is more likely to cause withdrawal effects if stopped suddenly. Paroxetine is generally considered safe for most patients, with a similar list of side effects to other SSRIs, although a controlled-release version was developed to help reduce the risk of nausea.

Paxil

is the brand name

image of different drug pills on a surface

Paroxetine Hydrochloride 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 Hydrochloride Affects Patients

Paroxetine is used to treat depression, anxiety disorders, post-traumatic stress disorder, obsessive-compulsive disorder, and the hot flashes associated with menopause. It works by blocking the reuptake of serotonin, a neurotransmitter in the brain. The effects of paroxetine usually become noticeable after about 6 weeks. However, if taken with certain medications that block monoamine oxidase (MAO), it can cause serotonin syndrome, a potentially dangerous side effect. Therefore, it is recommended to wait two weeks before taking paroxetine after stopping MAO inhibitors.

How Paroxetine Hydrochloride works in the body

Paroxetine is a medication that works by increasing the amount of serotonin in the brain. This helps to reduce symptoms associated with depression, anxiety, and menopause. It does this by blocking the reuptake of serotonin, meaning it prevents serotonin from leaving the brain. Paroxetine also has a small effect on other brain chemicals, but it mainly works on serotonin. This drug takes some time for its effects to be seen, as it first needs to activate certain receptors, which then allows serotonin to build up in the brain.

When to interrupt dosage

The measure of Paroxetine Hydrochloride is subject to the diagnosed affliction, including Post Traumatic Stress Disorder, Depression and Irritable Bowel Syndrome (IBS). The dosage can differ as per the technique of delivery (e.g. Oral or Capsule - Oral) featured in the table below.

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

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

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

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

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

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

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

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

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

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

Warnings

Paroxetine Hydrochloride has five contraindications, therefore it should not be administered in circumstances of the conditions detailed in the following table.

Paroxetine Hydrochloride 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 Hydrochloride.

Common Paroxetine Hydrochloride 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 Hydrochloride Toxicity & Overdose Risk

The toxic dose of paroxetine in mice and rats is 350mg/kg. A fatal overdose of paroxetine is typically around 400mg, while the highest reported non-fatal overdose was 2000mg. Symptoms of a paroxetine overdose include fatigue, fever, difficulty sleeping, high blood pressure, rapid heartbeat, nausea, vomiting, drowsiness, shaking, dizziness, irritability, anxiety, headache, excessive sweating, enlarged pupils, seizures, and changes in mental status. There is no known antidote for an overdose of paroxetine.

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

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

Currently, 539 active trials are being conducted to investigate the utility of Paroxetine Hydrochloride in treating Post Traumatic Stress Disorder, Premature Ejaculation and Menopausal symptoms.

Condition

Clinical Trials

Trial Phases

Social Anxiety Disorder

16 Actively Recruiting

Not Applicable

Depression

216 Actively Recruiting

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

Obsessive-Compulsive Disorder

63 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

235 Actively Recruiting

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

Panic Disorder

13 Actively Recruiting

Not Applicable

Irritable Bowel Syndrome

5 Actively Recruiting

Not Applicable, Phase 2, Early Phase 1

Hot Flashes

5 Actively Recruiting

Phase 2, Not Applicable

Premature Ejaculation

0 Actively Recruiting

Hot flashes

19 Actively Recruiting

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

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

5

Patient Review

3/10/2019

Paroxetine Hydrochloride for "Change of Life" Signs

Hot flashes have decreased significantly, now only occurring a few times per day. I've also been feeling sleepy in the evenings, but it's a welcome opportunity to relax. Another plus is that I've lost weight due to lack of appetite. Finally, I have more energy in the mornings and can be more productive with my time.

5

Patient Review

7/2/2022

Paroxetine Hydrochloride for Depression

I've been taking paroxetine for 25 years and it's really improved my quality of life. I've tried to wean myself off a few times but the anxiety and depression come back too strong without it. I'm currently on a maintenance dose of 20mg and doing well.

5

Patient Review

12/15/2018

Paroxetine Hydrochloride for "Change of Life" Signs

This is the best medication I've tried for hot flashes.

5

Patient Review

7/2/2022

Paroxetine Hydrochloride for Depression

I've been taking Paroxetine for 25 years and it has completely changed my life. I've tried to wean myself off a few times, but the anxiety and depression come back extremely quickly and severely without it. I'm stable on a maintenance dose of 20mg now, and at 61 years old, I'm in excellent mental and physical health.

5

Patient Review

9/10/2017

Paroxetine Hydrochloride for Depression

I've been using this treatment for a few years and it works great for me.

5

Patient Review

9/10/2017

Paroxetine Hydrochloride for Depression

I've been taking this medication for a few years and have found it to be very effective.

5

Patient Review

12/15/2018

Paroxetine Hydrochloride for "Change of Life" Signs

I've tried a few different medications for hot flashes, and this one is by far the best.

5

Patient Review

3/10/2019

Paroxetine Hydrochloride for "Change of Life" Signs

I've been taking this for three months now, and it's cut down my hot flashes to just a few times a day. I also find myself getting sleepy earlier in the evening, but that's not necessarily a bad thing. My mouth has gotten really dry though, so I'm drinking more water. I've also lost weight because of decreased appetite, which is great. Overall, I have more energy in the morning and can get more done.

4.7

Patient Review

8/16/2019

Paroxetine Hydrochloride for Panic Disorder

I'm really happy with Paroxetine. I've been taking 20 mg per day since June 2018 and saw a significant change after about six weeks. The few side effects I experienced in the beginning were totally worth it, because this medication has completely changed my life for the better.

4.7

Patient Review

9/29/2020

Paroxetine Hydrochloride for Major Depressive Disorder

I've been on this medication for 19 years and it's always done a great job at evening out my mood swings. However, recently I started experiencing some unpleasant side effects in the form of tinnitus. Not sure what to do about it at this point.

4.7

Patient Review

8/16/2019

Paroxetine Hydrochloride for Panic Disorder

I'm quite pleased with Paroxetine. I've been taking 20 mg per day since June 2018 and saw results within a month or two. There were some mild side effects at first, but after sticking it out they disappeared and I found the medication to be incredibly helpful for managing my panic attacks and anxiety.

4.7

Patient Review

9/29/2020

Paroxetine Hydrochloride for Major Depressive Disorder

I've been pretty happy with this medication for the last 19 years. It's helped me a lot with my mood swings, and my husband has noticed too. However, recently I've been having some titinits (a type of muscle spasm) that are really bothersome and I don't know what to do about it.

4.7

Patient Review

8/25/2022

Paroxetine Hydrochloride for Panic Disorder

After a really tough initial period, this medication started working and really helped me. It's been life-changing in the best way possible.

4.7

Patient Review

6/27/2022

Paroxetine Hydrochloride for Panic Disorder

I really feel like this medication has given me my life back. It's helped so much with my tourrettes and I'm incredibly grateful.

4.7

Patient Review

6/27/2022

Paroxetine Hydrochloride for Panic Disorder

I'm feeling great since I started this medication. It's also curbed my tics from tourrettes.

4.7

Patient Review

8/25/2022

Paroxetine Hydrochloride for Panic Disorder

At first, this medication was really tough to get through. The first few weeks were incredibly difficult. However, after a month or so it started working and I've been feeling much better since then. This treatment saved my life and I'm grateful for that.

4.3

Patient Review

1/10/2019

Paroxetine Hydrochloride for "Change of Life" Signs

This is the best treatment I've tried for hot flashes. They've gone from happening every hour to just three times a day. Additionally, it's helped with my mood swings.

4.3

Patient Review

8/21/2020

Paroxetine Hydrochloride for Panic Disorder

It took some time for this medication to take effect, but once it did I noticed a significant decrease in my anxiety levels. I'm glad to report that I haven't had a major panic attack since starting this treatment.

4.3

Patient Review

8/21/2020

Paroxetine Hydrochloride for Panic Disorder

It took some time for this medicine to take effect, but once it did, I found that my anxiety was greatly alleviated. I haven't had a single panic attack since starting this treatment regimen.

4.3

Patient Review

1/10/2019

Paroxetine Hydrochloride for "Change of Life" Signs

This has been the most effective treatment I've tried for hot flashes. They've gone from happening every hour to only a few times a day. Additionally, it's helped to stabilize my mood which is great.

4

Patient Review

6/27/2022

Paroxetine Hydrochloride for Posttraumatic Stress Syndrome

This medication has helped me a lot with my anxiety and tourrettes. The only downside is that it makes it hard to orgasm, but that side effect eventually went away on its own. Overall, this medication has given me back my life and personality.

4

Patient Review

11/4/2021

Paroxetine Hydrochloride for Panic Disorder

I've been taking 12.5mg ER since November of 2018 and it has helped to reduce the frequency and intensity of my panic attacks. The medication does make me sleepy, but I am still able to function relatively normally.

4

Patient Review

11/4/2021

Paroxetine Hydrochloride for Panic Disorder

I've been taking 12.5mg of this medication since November 2018 and it has helped to lessen the intensity and frequency of my panic attacks. I do find that it makes me tired, but not excessively so.

4

Patient Review

6/27/2022

Paroxetine Hydrochloride for Posttraumatic Stress Syndrome

This medication has helped me a great deal with my anxiety and tourrettes. The only downside is that I've lost the ability to orgasm, but thankfully that seems to be subsiding. All in all, this meds has allowed me to have a much better quality of life.

3.7

Patient Review

7/12/2021

Paroxetine Hydrochloride for "Change of Life" Signs

I've been on the medication for 24 days now. I have experienced fewer hot flashes, but when I do get them they're accompanied by profuse sweating. Additionally, I find myself sleeping more hours than usual. Overall, it's decent so far but I'll wait a few more months before deciding if I want to continue taking it.

3.7

Patient Review

2/1/2018

Paroxetine Hydrochloride for Repeated Episodes of Anxiety

I've been on this medication for a little over a month now, and while it has helped my anxiety, I sometimes experience shaking and sweating. It's not pleasant, and I'm considering asking my doctor to switch me to something else.

3.7

Patient Review

2/1/2018

Paroxetine Hydrochloride for Repeated Episodes of Anxiety

I've been on this medication for a little over a month now, and it does help with my anxiety. However, I sometimes experience shaking and sweating which makes me feel uncomfortable. I'm considering talking to my doctor about changing medications.

3.7

Patient Review

7/12/2021

Paroxetine Hydrochloride for "Change of Life" Signs

I've been on this for 24 days now. I have less hot flashes, but when I walk I sweat really bad and my body feels incredibly hot.Overall, I'm drinking more water and sleeping more hours. I'll give it 3 months before deciding if I want to continue with this medicine.

2.3

Patient Review

9/20/2017

Paroxetine Hydrochloride for Posttraumatic Stress Syndrome

At first, I thought this dosage was working for me. But after three months, I suddenly became very depressed and my anxiety skyrocketed.

2.3

Patient Review

9/20/2017

Paroxetine Hydrochloride for Posttraumatic Stress Syndrome

I was initially pleased with the results of this medication, but after three months I began to experience increased depression and anxiety.

2

Patient Review

5/4/2021

Paroxetine Hydrochloride for "Change of Life" Signs

I waited for this to work, but after taking the entire bottle I'm no closer to understanding what it's supposed to do.

2

Patient Review

5/4/2021

Paroxetine Hydrochloride for "Change of Life" Signs

I waited for this to work, but it didn't. I'm not sure what it's supposed to be used for.

1

Patient Review

6/5/2022

Paroxetine Hydrochloride for Panic Disorder

I took 20mg for 4 days. It was awful. Headaches and nausea. Rang GP and asked to stop. The following 6 days have been the worst in my life. Extreme nausea, cant sleep, feeling like i cant breathe properly, diorreah, crying, severe anxiety. Its the worst withdrawal i have ever experienced. I spent days just constantly pacing around. I wish i had never taken this med

1

Patient Review

6/5/2022

Paroxetine Hydrochloride for Panic Disorder

I wish I had never taken this medication. It caused me nothing but headaches and nausea for the four days that I took it, and the withdrawal has been even worse. For six days now I've been dealing with non-stop nausea, anxiety, diarrhea, and more.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about paroxetine hydrochloride

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

What are the side effects of taking paroxetine?

"headache, dizziness, weakness, difficulty concentrating, nervousness, forgetfulness, confusion, sleepiness."

Answered by AI

Is paroxetine a sleeping pill?

"This medication is used to treat major depressive disorder, obsessive-compulsive disorder, panic disorder, social anxiety disorder, and premenstrual dysphoric disorder.

Paroxetine is a drug that is used to treat various mental disorders. It is known as a selective serotonin reuptake inhibitor, which means that it helps to restore the balance of serotonin in the brain. This can improve symptoms such as mood swings, anxiety, and depression. It can also help to improve sleep, appetite, and energy levels, and restore interest in everyday activities."

Answered by AI

What is paroxetine hydrochloride used for?

"The drug Paroxetine is used to to treat a number of mental disorders which include: depression, OCD, panic disorder, generalized anxiety disorder, social anxiety disorder, premenstrual dysphoric disorder, and posttraumatic stress disorder."

Answered by AI

Is paroxetine a strong antidepressant?

"Among the SSRIs, fluoxetine and paroxetine are highly potent inhibitors of 2D6, while sertraline is only a moderate inhibitor. Women taking SSRIs that weakly inhibit 2D6 have a 8.8% risk of breast cancer recurrence, as opposed to the 7.5% risk in women not taking these drugs."

Answered by AI

Clinical Trials for Paroxetine Hydrochloride

Image of VA Greater Los Angeles Healthcare System, West Los Angeles, CA in West Los Angeles, United States.

EBQI Strategies for Women's Health

Any Age
All Sexes
West Los Angeles, CA

Women Veterans are the fastest growing segment of VA users, with most users in midlife. This dramatic growth has created challenges for VA to ensure that appropriate services are available to meet women Veterans' needs, and that they will want and be able to use those services. Furthermore, few VA improvement efforts have focused on women Veterans' health and health care in midlife. The EMPOWER QUERI 3.0 Program is a cluster randomized type 3 hybrid implementation-effectiveness trial testing two strategies designed to support implementation and sustainment of evidence-based practices for women Veterans in at least 18 VA facilities from 4 regions.

Waitlist Available
Has No Placebo

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Erin P Finley, PhD MPH

Image of Stanford University School of Medicine in Stanford, United States.

BEAR Program for Suicidal Thoughts

18 - 75
Female
Stanford, CA

The current study aims to test the feasibility of a new form of group therapy for women who have a history of interpersonal trauma and current suicidal ideation. The Building Empowerment and Resilience (BEAR) Therapeutic group has been adapted for women who have experienced trauma and have current suicidal ideation. It incorporates psychological skills, psychoeducation about trauma and gender-based violence, and physical self-defense training, all within a therapeutic process. It will be implemented with women who have experienced interpersonal trauma (physical, sexual, or emotional abuse/neglect) and experience various mental health difficulties, including suicidal ideation. We aim to assess the feasibility to recruit and implement the BEAR group. Our ultimate aim is to assess whether the program can effect self-efficacy and suicidal ideation.

Waitlist Available
Has No Placebo

Stanford University School of Medicine

Jennifer Keller, PhD

Have you considered Paroxetine Hydrochloride clinical trials?

We made a collection of clinical trials featuring Paroxetine Hydrochloride, we think they might fit your search criteria.
Go to Trials
Image of Inova Schar Cancer Institute in Fairfax, United States.

Acupuncture for Prostate Cancer

18+
Male
Fairfax, VA

Prostate cancer is the most common cancer among men in the United States. Many men with prostate cancer are treated with hormone therapy, also called androgen deprivation therapy (ADT). While this treatment is effective, it often causes bothersome side effects such as hot flashes, poor sleep, fatigue, and other physical and emotional symptoms. There is currently no standard treatment to help manage these side effects in men. Acupuncture is a non-drug treatment that has been shown to help reduce hot flashes and related symptoms in women receiving hormone therapy for breast cancer. However, much less is known about whether acupuncture is helpful for men receiving hormone therapy for prostate cancer. This study will test whether an acupuncture program, combined with usual lifestyle education, is feasible and acceptable for men undergoing ADT. The study will also explore whether acupuncture may help reduce hot flashes and improve related symptoms. A total of 24 men with prostate cancer receiving ADT will be randomly assigned to one of two groups: one group will begin acupuncture right away, and the other group will begin acupuncture after a delay, with regular check-ins during the waiting period. All participants will receive standard lifestyle education. Participants will be followed for about five months and will be asked to complete daily hot flash diaries, questionnaires about their symptoms and quality of life, and wear a Fitbit to track sleep. The results of this pilot study will help determine whether a larger study should be conducted to better understand the role of acupuncture in managing hormone therapy side effects in men with prostate cancer.

Waitlist Available
Has No Placebo

Inova Schar Cancer Institute

Jeanny Aragon-Ching, MD

Image of Pavillon Adrien-Pinard (SU) in Montreal, Canada.

Cognitive Remediation for PTSD

18 - 45
All Sexes
Montreal, Canada

The goal of this clinical trial is to evaluate whether computer-based brain training can help adults with post-traumatic stress disorder (PTSD). Individuals with PTSD often experience difficulties with memory, attention, concentration, and problem-solving, which can significantly affect their daily lives, work performance, and overall quality of life. These cognitive challenges can hinder trauma recovery and reduce the effectiveness of standard PTSD treatments. The main questions this study seeks to address are: Does specialized brain training improve PTSD symptoms compared to regular computer games? Does brain training enhance cognitive functions such as memory, attention, processing speed, and executive functioning? Does brain training improve quality of life and daily functioning? Do participants' self-efficacy and perceived social support influence treatment outcomes? Researchers will compare two approaches: a specialized cognitive training program (HAPPYneuron Pro) with strategy teachings and quality-of-life discussions, versus engaging computer games with quality-of-life discussions, to determine which is more effective for people with PTSD. Study Design Participants will be randomly assigned to one of two groups for an 8-week program: Cognitive remediation training group: Complete computerized cognitive exercises and strategy teachings specifically designed to strengthen memory, attention, and executive functions, combined with quality-of-life discussions. Control group: Complete engaging computer games combined with quality-of-life discussions. Schedule Both groups will follow the same schedule: One online session per week, in small and consistent groups of 6 participants. Each 60-minute session consists of 30 minutes of computer activities followed by 45 minutes of group discussion. One at-home individual homework exercise per week (30 minutes at home). Total time commitment: 1h45 per week for 8 weeks. Assessments All participants will complete three comprehensive assessment sessions: before treatment, immediately after the 8-week program, and 3 months later. Assessments include neuropsychological testing and questionnaires on PTSD symptoms, depression, anxiety, quality of life, satisfaction with life, social support, cognitive failures, and self-efficacy. Significance This research evaluates a new, accessible and remotely deliverable approach for PTSD treatment. Current evidence-based treatments often do not directly target the cognitive impairments experienced by many individuals with PTSD. Compensation Participants will receive $35 for each completed assessment (maximum $105). Control group participants will gain access to the cognitive remediation training program after completing their participation.

Recruiting
Online Trial

Pavillon Adrien-Pinard (SU)

Have you considered Paroxetine Hydrochloride clinical trials?

We made a collection of clinical trials featuring Paroxetine Hydrochloride, we think they might fit your search criteria.
Go to Trials
Image of Walter Reed National Military Medical Center/Uniformed Services University in Bethesda, United States.

NightWare Smartwatch for Insomnia

18 - 62
All Sexes
Bethesda, MD

The INSIGHT study is a multi-site clinical research program designed to examine how insomnia and symptoms of sympathetic hyperactivity impair sleep, cognition, and physiological restoration in warfighters, and to evaluate whether a wearable therapeutic device can improve these outcomes. Warfighters with a history of traumatic brain injury, post-traumatic stress disorder, or chronic operational stress commonly report disrupted sleep accompanied by manifestations of nocturnal sympathetic activation such as diaphoresis, palpitations, hyperarousal, and nightmares. These symptoms erode sleep quality, reduce cognitive performance, and undermine psychological resilience and operational readiness. Insomnia is two to three times more common in military populations than in civilians, and both TBI and PTSD independently elevate the risk for dysregulated autonomic tone. Excessive sympathetic activity during REM sleep disrupts the normally quiescent locus coeruleus state required for adaptive emotional processing and may contribute to the genesis of nightmares. Excessive sympathetic tone may also interfere with deep NREM-dependent glymphatic clearance, a recently discovered mechanism that supports cognitive restoration and metabolic waste removal. Yet, no study has comprehensively linked these physiological processes in warfighters or evaluated whether wearable-derived autonomic measures can meaningfully stratify insomnia phenotypes. The INSIGHT protocol addresses this gap through a two-phase design integrating multimodal biomarker collection, wearable technology validation, advanced imaging, and a randomized controlled intervention. Phase 1 enrolls 250 participants (50 healthy controls and 200 poor sleepers with or without PTSD and TBI) who undergo structured screening, cognitive testing, and detailed baseline assessments before completing a 2-week at-home data collection period. During this period, participants wear a suite of devices, including EEG headbands, ECG patches, PPG-based sensors, accelerometry rings, blood pressure devices, temperature sensors, and smartwatches, to capture autonomic activity, sleep architecture, cardiovascular and respiratory variability, movement, sudomotor activity, and circadian body temperature patterns. Ecological momentary assessments administered three times daily track fluctuations in sleep quality, mood, PTSD symptoms, and daytime functioning, while urine samples collected on the final three days allow for biochemical analysis of hormonal and sympathetic biomarkers. After the at-home period, all participants complete an overnight in-lab polysomnogram combined with fNIRS to measure sleep stages, autonomic dynamics, cerebral hemodynamics, and glymphatic signatures. A subset of participants also completes an optional overnight MRI with simultaneous EEG following controlled sleep deprivation, enabling state-of-the-art imaging of human glymphatic activity using the MAGNUS MRI platform. This optional visit provides unprecedented insight into how TBI, PTSD, and insomnia alter the physiology of sleep-dependent brain fluid dynamics. In Phase 2, all poor sleepers enter a double-blind, sham-controlled, 30-day randomized trial testing the therapeutic potential of the NightWare smartwatch. NightWare detects sympathetic surges during sleep through heart rate elevations and movement patterns and delivers brief haptic vibrations aimed at interrupting escalating autonomic arousal. Although originally cleared for nightmare treatment, its mechanism is well suited for SNH-related insomnia more broadly. Participants use the device daily while continuing EMA surveys, wearable monitoring, and cognitive assessments, generating rich physiological and behavioral data throughout the intervention. The primary goal is to determine whether reducing nocturnal sympathetic spikes leads to measurable improvements in sleep quality, autonomic stability, daytime functioning, and symptom burden. In parallel, Phase 2 data enable development of the Multi-Organ Autonomic Index of Sleep, an integrated biomarker model that combines neurological, cardiovascular, respiratory, and dermal signals to predict treatment response and classify insomnia subtypes. The INSIGHT study will produce the most comprehensive dataset to date linking autonomic physiology, glymphatic function, sleep architecture, wearable-derived biomarkers, cognition, and clinical outcomes in warfighters. By identifying physiological signatures of sympathetic hyperarousal and determining whether a non-pharmacological wearable intervention can meaningfully improve sleep, INSIGHT directly supports Department of Defense priorities to enhance readiness, resilience, and long-term neurological health in service members. Wearable tools capable of monitoring and improving sleep outside the laboratory have the potential to transform both clinical care and operational performance, offering scalable and accessible approaches to restoring sleep and optimizing recovery.

Waitlist Available
Paid Trial

Walter Reed National Military Medical Center/Uniformed Services University (+1 Sites)

Image of Emory Brain Health Center in Atlanta, United States.

MDMA-Assisted Therapy for PTSD

21 - 70
All Sexes
Atlanta, GA

The goal of this clinical trial is to investigate the efficacy of 3,4-methylenedioxy-methamphetamine hydrochloride (MDMA) combined with Massed Prolonged Exposure (PE) therapy for the treatment of posttraumatic stress disorder (PTSD) in adult participants diagnosed with PTSD. This randomized, placebo-controlled trial will enroll 95 participants. The main questions it aims to answer are: * Does the combination of PE + MDMA lead to greater reduction in PTSD symptom severity from pre-treatment to one-month follow-up compared to PE + placebo? * Does PE + MDMA improve response efficiency and durability of PTSD symptom improvement compared to PE + placebo? * Does MDMA + PE enhance extinction retention and reduce amygdala threat reactivity, and are these changes associated with improved PTSD outcomes? Participants will: * Receive 10 sessions of Massed Prolonged Exposure therapy over two weeks * Be administered either 100 mg of MDMA or a placebo at Visit 2 * Undergo blinded independent evaluator assessments using the Clinician-Administered PTSD Scale for DSM-5-R (CAPS-5-R) at the one-month posttreatment follow-up

Phase 2
Waitlist Available

Emory Brain Health Center

Jessica Maples-Keller, PhD

Have you considered Paroxetine Hydrochloride clinical trials?

We made a collection of clinical trials featuring Paroxetine Hydrochloride, we think they might fit your search criteria.
Go to Trials