Ongoing Clinical Trials for Post-traumatic Stress Disorder
This article provides information about 10 ongoing clinical trials investigating various treatments for post-traumatic stress disorder. These studies are taking place across several European countries and are testing medications including MDMA, ketamine, propranolol, cannabidiol, mifepristone, clonidine, doxazosin, methylone, and hydrocortisone, alongside different therapy approaches for individuals affected by trauma.
Clinical trial locations
- Belgium
- France
- Germany
- Ireland
- Netherlands
- Study on Cannabidiol for Reducing Anxiety and PTSD Symptoms in Dutch Uniformed Personnel
- Study of Hydrocortisone Treatment to Improve Fear Response in Adults with Post-Traumatic Stress Disorder (PTSD) and Hormonal System Changes
- Study on MDMA-Assisted Therapy for Patients with Treatment-Resistant PTSD
- Study on Mifepristone for Patients with Treatment-Resistant Post-Traumatic Stress Disorder (PTSD)
Study on Ketamine and Sodium Chloride for Reducing Morphine Use in Patients with Severe Trauma
This trial is taking place in France and examines the use of ketamine in patients who have experienced severe trauma. While the study primarily focuses on pain management following serious injuries, it also monitors participants for the development of trauma-related psychological conditions.
Main inclusion criteria: Participants must be adults over 18 years old who have suffered severe trauma involving at least two different body areas or multiple bone injuries. They must have injuries rated as moderate to very severe and be enrolled in a social security scheme.
Main exclusion criteria: The study excludes individuals outside the specified age range and those considered part of vulnerable populations.
Study focus: The trial aims to determine whether low-dose ketamine can reduce the need for opioid pain medications by at least 25% within 48 hours after injury while maintaining effective pain relief. The study monitors participants over five days, tracking pain levels, side effects such as nausea and delirium, liver function, and overall recovery including quality of life.
Investigational drug: Ketamine Renaudin is administered as an injection with a concentration of 10 mg/ml.
Study on MDMA-Assisted Therapy for Patients with Treatment-Resistant PTSD
This trial is being conducted in the Netherlands and focuses on individuals whose condition has not responded to at least two previous trauma-focused therapies.
Main inclusion criteria: Participants must be at least 18 years old with a diagnosis confirmed for at least six months. They must score 40 or greater on the PTSD Checklist, indicating moderate to severe symptoms, and have previously tried at least two trauma-focused psychotherapies without success.
Main exclusion criteria: The study excludes individuals without a diagnosis, those outside the age requirement, and people unable to give informed consent.
Study focus: The trial evaluates MDMA-assisted therapy provided in a high-intensity inpatient setting. The primary measure is the change in symptom severity from baseline to 12 weeks post-baseline using standardized assessment tools. Secondary measures include changes in disability and tracking of dropouts.
Investigational drug: 3,4-methylenedioxymethamphetamine hydrochloride (MDMA HCl) is administered orally in capsule form during therapy sessions.
Study on Mifepristone for Patients with Treatment-Resistant Post-Traumatic Stress Disorder (PTSD)
This study is taking place in the Netherlands and tests whether mifepristone can help individuals who have not responded to other treatments.
Main inclusion criteria: Participants must speak and understand Dutch, be 18 years or older, and have treatment-resistant symptoms with a score of 30 or higher on the assessment scale. They must not have responded to two recommended treatments, including at least one full course of trauma-focused therapy.
Main exclusion criteria: The study excludes individuals without a diagnosis, children and teenagers, and those unable to provide consent.
Study focus: The trial compares mifepristone to placebo over seven days at a daily dose of 1200 milligrams. Symptom severity is assessed at four weeks and twelve weeks, with weekly monitoring of symptom changes. Additional evaluations measure disability, sleep quality, stress levels, anxiety, depression, and suicidal thoughts.
Investigational drug: Mifepristone is a glucocorticoid receptor antagonist taken orally in tablet form.
Study on the Effectiveness of Reconsolidation Therapy with Propranolol for Patients with Severe Post-Traumatic Stress Disorder
This Belgian trial investigates whether propranolol can enhance the effectiveness of prolonged exposure therapy for individuals with severe and chronic symptoms requiring hospital care.
Main inclusion criteria: Participants must be between 18 and 65 years old, currently staying in a psychiatric care unit, speak French as their first language, and have a confirmed diagnosis. Women of childbearing potential must use contraception and have a negative pregnancy test.
Main exclusion criteria: The study excludes patients outside the age range, those with severe heart problems or uncontrolled high blood pressure, pregnant or breastfeeding women, and individuals with known allergies to propranolol.
Study focus: Participants are randomly assigned to receive prolonged exposure therapy either with or without propranolol. The study lasts up to six months and uses various scales to assess changes in symptoms, emotions, and overall well-being.
Investigational drug: Inderal (propranolol) is administered orally in film-coated tablets at doses of either 10 mg or 40 mg, with a maximum daily dose of 80 mg.
Study on Cannabidiol for Reducing Anxiety and PTSD Symptoms in Dutch Uniformed Personnel
This Netherlands-based trial focuses specifically on Dutch uniformed personnel such as police officers, firefighters, ambulance paramedics, military personnel, and veterans.
Main inclusion criteria: Participants must be members of Dutch uniformed services, aged between 18 and 65, and waiting for therapy for trauma or anxiety disorders as determined by psychiatric interview.
Main exclusion criteria: The study excludes individuals with certain psychological disorders, those outside the age range, and people considered part of vulnerable populations.
Study focus: The trial explores whether a two-week course of cannabidiol (CBD) can reduce anxiety symptoms before starting therapy. Researchers monitor changes in anxiety levels using Beck’s anxiety index and assess effects on fear responses, stress regulation, and sleep quality through questionnaires, physiological measurements, and sleep monitoring.
Investigational drug: Cannabidiol (CBD) is administered in capsule form taken orally daily for two weeks.
Study on Propranolol for Preventing PTSD in Women After Sexual Violence
This French trial focuses on early prevention in women who have recently experienced sexual violence.
Main inclusion criteria: Participants must be female adults over 18 who can understand French, with a heart rate of at least 55 beats per minute and systolic blood pressure greater than 10 cm Hg. They must have been seen at a medical unit for sexual violence within 72 hours after the incident and be enrolled in social security.
Main exclusion criteria: Men and individuals considered part of vulnerable populations cannot participate.
Study focus: The study evaluates whether taking propranolol soon after trauma can reduce the occurrence of symptoms. Participants receive either propranolol or placebo and are followed over time with symptom assessments at five weeks, three months, and six months. The trial also evaluates functioning, healthcare costs, suicide risk, and any adverse events.
Investigational drug: Propranolol 40 mg is administered orally in film-coated tablets.
Study of Hydrocortisone Treatment to Improve Fear Response in Adults with Post-Traumatic Stress Disorder (PTSD) and Hormonal System Changes
This Netherlands trial examines whether hydrocortisone can help improve therapy outcomes in individuals whose stress response system has been affected by trauma.
Main inclusion criteria: Participants must be aged 18-64 with a confirmed diagnosis and currently experiencing significant symptoms. They must either be starting trauma-focused therapy or be willing to complete a diagnostic interview.
Main exclusion criteria: The study excludes individuals with current or past psychotic disorders, current bipolar disorder, current substance use disorder (except nicotine and caffeine), pregnancy or breastfeeding, recent use of corticosteroids, severe allergic reactions to medications, traumatic brain injury with prolonged loss of consciousness, and active thoughts of self-harm.
Study focus: The study consists of two parts. The first examines how childhood difficulties affect the body’s stress system. The second tests whether hydrocortisone can help patients learn to feel safe in situations that previously caused fear responses. Participants provide saliva samples and undergo assessments using virtual reality technology, with some also receiving brain scans.
Investigational drug: Hydrocortisone is administered orally in tablet form at a dose of 20 mg.
Evaluation of clonidine and doxazosin for treating nightmares in adults with Post-traumatic Stress Disorder
This German trial focuses specifically on treating nightmares, a common and distressing symptom.
Main inclusion criteria: Participants must be diagnosed with a score of at least 26 points on the assessment scale and experience at least two nightmares per week that are moderately distressing or worse. They must be between 18 and 65 years old and have stable medication for at least four weeks. Women who can become pregnant must have a negative pregnancy test and use reliable birth control.
Main exclusion criteria: The study excludes individuals with severe depression or active thoughts of self-harm, allergies to the study medications, pregnancy or breastfeeding, severe heart conditions, liver or kidney disease, substance abuse within the past three months, sleep apnea, participation in other trials within 30 days, and history of fainting or severe blood pressure drops.
Study focus: Participants are randomly assigned to receive clonidine, doxazosin, or placebo for 10 weeks after an initial placebo week. The study monitors nightmare frequency and intensity through daily sleep diaries, along with overall symptoms, sleep quality, depression levels, and quality of life.
Investigational drugs: Clonidine tablets at 0.075-0.375 mg and doxazosin tablets at 1-10 mg are administered orally in capsule form.
Study of Methylone Treatment for Adults with Post-Traumatic Stress Disorder (PTSD)
This Irish trial investigates methylone as a potential new treatment option.
Main inclusion criteria: Participants must have moderate to severe symptoms lasting at least six months, confirmed by specialist assessment with specific score requirements. They must have previously tried at least one treatment without sufficient improvement, be able to read and write in the local language, be in generally good health, and be adults.
Main exclusion criteria: The study excludes individuals with major psychiatric disorders other than the condition being studied, substance abuse within six months, pregnancy or breastfeeding, use of interacting medications, severe or unstable medical conditions, seizures or neurological disorders, liver or kidney disease, cardiovascular conditions, previous adverse reactions to similar medications, participation in other trials within 30 days, inability to provide consent, suicidal behavior or thoughts, inability to attend visits, and active legal issues.
Study focus: The study is divided into two parts. Part A focuses on safety and tolerability with all participants receiving methylone. Part B examines effectiveness by comparing methylone to placebo. Treatment is given once weekly for four weeks, followed by additional monitoring. Regular health assessments, vital signs monitoring, blood tests, and heart monitoring are conducted throughout.
Investigational drug: Methylone (TSND-201) is administered orally in 50 mg capsules.
Study on the Long-term Effects of Methylone for Treating PTSD in Patients
This Irish trial is a long-term follow-up study for participants who completed the previous methylone trial.
Main inclusion criteria: Participants must have previously participated in the IMPACT-1 trial. The study is open to both young adults and middle-aged adults of both genders, including individuals who may be considered part of vulnerable populations.
Main exclusion criteria: Individuals without the condition, those outside the specified age range, and those who do not identify as male or female may not be eligible.
Study focus: This extension study evaluates the long-term effectiveness and safety of methylone over 52 weeks. Participants receive both single and repeated treatments, with regular assessments of symptom changes, mental health, mood, and overall well-being. The study includes monitoring for adverse events, vital signs, laboratory tests, and electrocardiograms throughout the treatment period.
Investigational drug: Methylone is administered orally in 50 mg capsules.
Summary
These 10 ongoing clinical trials represent diverse approaches to treating post-traumatic stress disorder across several European countries. The Netherlands hosts the largest number of trials with four studies, followed by France and Ireland with two trials each, and Belgium and Germany with one trial each. This concentration of research in the Netherlands suggests a particularly strong research interest in trauma-related conditions within Dutch medical institutions.
The trials test a wide range of medications with different mechanisms of action. Several studies focus on treatment-resistant cases, indicating recognition of the need for alternative approaches when standard treatments fail. Specialized populations are also addressed, including uniformed personnel in the Netherlands and women who have experienced sexual violence in France. The German trial specifically targets nightmares, acknowledging this distressing symptom as worthy of dedicated treatment research.
Some medications being tested, such as propranolol and hydrocortisone, are already approved for other conditions and are being repurposed for trauma treatment. Others, like MDMA and methylone, represent more novel approaches requiring careful evaluation of both safety and effectiveness. The variety of research approaches reflects the complexity of the condition and the ongoing search for more effective treatment options for those affected by trauma.
