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New treatment option for Post Traumatic Stress Disorder
Official title Silexan in the Treatment Of Posttraumatic Stress Disorder Trial
ClinicalTrials.gov ID: NCT06412757
What this study is testing
What is Silexan?
Silexan is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for post traumatic stress disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Posttraumatic stress disorder (PTSD) is a common and debilitating mental illness. Current treatments for PTSD include psychotherapy and antidepressant medications.
- Phase 3: a large, late-stage study
- Time commitment: about 12 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Aged 18 years or over.
- Fluent in English.
- Meet DSM-5 criteria for PTSD, irrespective of occupation (e.g. first responder, police officer, ex-military or civilian), determined using the Mini...
- Have a score on the PTSD Checklist for DSM-5 (PCL-5) equal to or over 33.
You likely can't join if
- Are currently serving in the Australian Defence Force
- Lifetime history of a psychotic or bipolar disorder, or dissociative identity disorder.
- Moderate or severe alcohol or other substance use disorder within 3 months of screening.
- Active suicidal or homicidal ideation.
- Borderline Personality Disorder (BPD).
- Acute or unstable medical illness or other significant medical condition, that would make participation in the trial unsafe or inappropriate.
See the full eligibility criteria
- Aged 18 years or over.
- Fluent in English.
- Meet DSM-5 criteria for PTSD, irrespective of occupation (e.g. first responder, police officer, ex-military or civilian), determined using the Mini International Neuropsychiatric Interview 7.0.2.
- Have a score on the PTSD Checklist for DSM-5 (PCL-5) equal to or over 33.
- Are currently serving in the Australian Defence Force
- Lifetime history of a psychotic or bipolar disorder, or dissociative identity disorder.
- Moderate or severe alcohol or other substance use disorder within 3 months of screening.
- Active suicidal or homicidal ideation.
- Borderline Personality Disorder (BPD).
- Acute or unstable medical illness or other significant medical condition, that would make participation in the trial unsafe or inappropriate.
- Pregnancy, lactation or unwillingness to use an acceptable method of contraception (required for both males and females who are of reproductive potential and sexually active with partners of the opposite sex) through...
- Commencement of a trauma-focussed psychotherapy (including Prolonged Exposure, Cognitive Processing Therapy and Eye Movement Desensitisation and Reprocessing) within 3 months of screening.
- Commencement or change in dose of psychoactive medications within 4 weeks of screening.
- Participants will be asked not to initiate psychotherapy or change the dose of psychoactive medications during the course of the study except in clinically urgent circumstances; if this becomes necessary, a decision...
- Severe acquired brain injury.
- Individual is not eligible for public mental health services due to their visa status in Australia or for any other reason.
- Any other condition that in the opinion of the research team is likely to make completion of the trial requirements infeasible.
- Inability to understand or speak English to the extent necessary to give informed consent and complete the trial (researcher or clinician-determined).
The study team makes the final eligibility decision.
Where it's taking place
- Carlton, Victoria, Australia
- Geelong, Victoria, Australia
- Heidelberg, Victoria, Australia
- Melbourne, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Carlton, Victoria, Australia; Geelong, Victoria, Australia; Heidelberg, Victoria, Australia; Melbourne, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.