Paxil Cr

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

Treatment

3 FDA approvals

20 Active Studies for Paxil Cr

What is Paxil Cr

Paroxetine

The Generic name of this drug

Treatment Summary

Paroxetine, sold under the brand name Paxil, is a medication used to treat anxiety, depression, post-traumatic stress disorder, and symptoms of menopause. It is a type of selective serotonin reuptake inhibitor (SSRI), meaning it specifically affects serotonin levels in the brain. Paroxetine is usually well tolerated but can cause withdrawal symptoms when stopped. To reduce nausea, there is a controlled release formula of the drug available.

Paxil

is the brand name

image of different drug pills on a surface

Paxil Cr 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 Paxil Cr Affects Patients

Paroxetine is used to treat depression, anxiety, post-traumatic stress disorder, obsessive-compulsive disorder, and menopause symptoms by preventing the reabsorption of serotonin. It usually takes about 6 weeks for the effects to be felt. Taking it with other drugs that affect serotonin levels, like MAO inhibitors, can cause dangerous side effects. It is important to wait 2 weeks after discontinuing any MAO inhibitor before taking paroxetine.

How Paxil Cr works in the body

Paroxetine helps regulate serotonin levels in the body. It does this by blocking the serotonin (SERT) receptor from taking serotonin away from the synapse. This raises serotonin levels, which can relieve symptoms. Paroxetine has been proven to be more effective at blocking serotonin reuptake than other drugs in its class. The exact way Paroxetine treats menopausal symptoms is still unknown, but it may be related to how it affects temperature regulation. Paroxetine also has a mild effect on certain receptors in the body, including adrenergic, dopamine, histamine, and serotonin receptors. Its delayed effects may be

When to interrupt dosage

The suggested dosage of Paxil Cr is contingent upon the recognized situation, like Post Traumatic Stress Disorder, Depression and Irritable Bowel Syndrome (IBS). The measure of dosage may differ, depending on the approach of delivery (e.g. Oral or Capsule - Oral) noted in the table beneath.

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

Paxil Cr has five contraindications, and thus should not be engaged when one is faced with the conditions in the subsequent table.

Paxil Cr 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 Paxil Cr.

Common Paxil Cr 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.

Paxil Cr Toxicity & Overdose Risk

The most toxic dose of paroxetine for mice and rats is 350 mg/kg. The lowest reported fatal dose of paroxetine is 400 mg; the highest reported dose of paroxetine that someone has survived is 2000 mg. Symptoms of paroxetine overdose can include tiredness, fever, high blood pressure, fast heartbeat, nausea, vomiting, drowsiness, trembling, confusion, anxiety, headache, sweating, dilated pupils, seizures, tingling sensations, serotonin syndrome, muscle contraction, and changes in mental status. There is no known antidote for paroxetine overdose.

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

Paxil Cr Novel Uses: Which Conditions Have a Clinical Trial Featuring Paxil Cr?

539 active trials are currently being conducted to examine the utility of Paxil CR in 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

Paxil Cr Reviews: What are patients saying about Paxil Cr?

5

Patient Review

11/13/2014

Paxil Cr for Major Depressive Disorder

Paxil has been a game-changer for me. I've suffered from depression since childhood, and this medication has helped alleviate many of the symptoms. I'm so grateful to have found something that helps me feel more like myself.

5

Patient Review

7/19/2015

Paxil Cr for Repeated Episodes of Anxiety

Paxil has been a life-saver for me. It's helped me manage my anxiety for 15 years without any negative side effects. I'm able to live a joyful and positive life thanks to this medication!

5

Patient Review

4/7/2015

Paxil Cr for Panic Disorder

Paxil has been a game-changer for me. I haven't had a panic attack in 20 years, and even just forgetting to take it on vacation for 3 days brought the attacks back.

5

Patient Review

9/23/2014

Paxil Cr for Panic Disorder

Paxil is an excellent drug for those suffering from OCD or panic disorder. I experienced very few side effects, and they were all manageable.

4.3

Patient Review

6/15/2016

Paxil Cr for Repeated Episodes of Anxiety

I come from a family with a history of anxiety, so my FNP put me on Paxil CR about 10 years ago. Over time, the dosage increased as needed. I was really struggling to function without the medication; however, it has helped me immensely and allowed me to enjoy life much more.

3.3

Patient Review

10/14/2018

Paxil Cr for Extreme Apprehension or Fear of Social Interaction

It took me an hour to ejaculate, but the results were worth it.

3

Patient Review

7/28/2016

Paxil Cr for Anxiousness associated with Depression

Though this medication helped me, I was still anxious. My doctor decided to switch me to Wellbutrin, but that turned out to be a mistake. I got very sick from it and had to withdraw from the Paxil. Be careful when changing medications!

3

Patient Review

9/6/2018

Paxil Cr for Extreme Apprehension or Fear of Social Interaction

I was convinced to take an SSRI in high school but Paxil had very little effect. The worst part was that it interfered with my sex life; I could barely ejaculate!

2.3

Patient Review

1/25/2015

Paxil Cr for Repeated Episodes of Anxiety

I've tried a lot of different antidepressants and, by far, Paxil was the worst experience. I constantly got migraines (even though I'd never had them before), slept for 16 hours a day, and couldn't focus or function when I was awake because of the headaches. There are so many better options out there than this one.

2

Patient Review

4/15/2014

Paxil Cr for Bipolar Depression

I found myself feeling really hyper one day, and then really down the next.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about paxil cr

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

What is Paxil CR used for?

"Paroxetine is a medication used to treat various forms of mental illness. These include depression, anxiety, panic attacks, and a severe form of premenstrual syndrome known as premenstrual dysphoric disorder. The drug works by correcting imbalances of the neurotransmitter serotonin in the brain."

Answered by AI

How long does it take for Paxil CR to work?

"In the first week or two, you may see some improvement in your sleep, energy levels, or appetite. This can be a good sign that the medication is working. However, it can take up to eight weeks for your mood and interest in activities to fully improve."

Answered by AI

Whats the difference between Paxil and Paxil CR?

"Paxil is a prescription medication that is used to treat depression, anxiety disorders, and other serious mental health problems. The medication is manufactured by GlaxoSmithKline and was the first medication to be approved for the treatment of social anxiety disorder (SAD). Paxil CR is the longer-acting, controlled-release version of the medication."

Answered by AI

What does the CR stand for in Paxil CR?

"Paxil and Paxil CR are indicated for the treatment of major depressive disorder, panic disorder and obsessive-compulsive disorder. Paxil was approved in May 1996."

Answered by AI

Clinical Trials for Paxil Cr

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

Image of White River Junction VA Hospital in White River Junction, United States.

Transcranial Magnetic Stimulation for PTSD

19 - 70
All Sexes
White River Junction, VT

With this research we hope to begin to understand how rTMS can improve posttraumatic stress disorder (PTSD) symptoms. TMS improves PTSD through two interrelated mechanisms: change in brain limbic system function and change in systemic inflammatory activation. If you decide to join this study, you will receive ten rTMS treatments. All participants will undergo a 40-minute rTMS procedure with a member of the study team 10 times over 2-4 weeks. Participants will undergo fMRI scans of the head in order to help researchers better understand potential effects of rTMS on brain activity. In addition, you will be asked to give two breath and blood samples to look for general signs of inflammation.

Recruiting
Has No Placebo

White River Junction VA Hospital

Bradley Watts

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

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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
New This Month

Pavillon Adrien-Pinard (SU)

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

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Image of UCLA Semel Institute in Los Angeles, United States.

Psilocybin-assisted CBT for Depression

21 - 60
All Sexes
Los Angeles, CA

The primary objectives of this clinical investigation are to (1) determine the acceptability and feasibility of joining psilocybin-assisted therapy with cognitive-behavioral therapy (PA-CBT) for patients with depression, (2) optimize CBT to most effectively integrate the psilocybin experience with psychotherapy and (3) examine the clinical benefit of psilocybin as an adjunct to cognitive-behavioral therapy (CBT) for major depressive disorder. This study is a randomized, two-arm, fixed dose trial that will test the feasibility, acceptability, and participant and therapist adherence to PA-CBT. Both treatment arms will receive two doses of psilocybin (10mg and then 25mg, separated by one month). In Phase II, participants will be randomized (1:1) to either a 12-session PA-CBT or a 6-session standard psilocybin-assisted therapy (PAT) condition (3 hours of preparation plus 3 hours of supportive therapy integration following the psilocybin experiences).

Phase 1 & 2
Recruiting

UCLA Semel Institute

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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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