Phase
Condition
Post-traumatic Stress Disorders
Treatment
Silexan
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion 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 InternationalNeuropsychiatric Interview 7.0.2.
Have a score on the PTSD Checklist for DSM-5 (PCL-5) equal to or over 33.
Exclusion
Exclusion Criteria:
Are currently serving in the Australian Defence Force
Lifetime history of a psychotic or bipolar disorder, or dissociative identitydisorder.
Moderate or severe alcohol or other substance use disorder within 3 months ofscreening.
Active suicidal or homicidal ideation.
Borderline Personality Disorder (BPD).
Acute or unstable medical illness or other significant medical condition, that wouldmake 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 sexuallyactive with partners of the opposite sex) through the duration of participants'involvement in the study up to and including week 16. Participants will also beadvised not to donate eggs or sperm during the study period.
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 ofscreening.
Participants will be asked not to initiate psychotherapy or change the dose ofpsychoactive medications during the course of the study except in clinically urgentcircumstances; if this becomes necessary, a decision will be made on a case-by-casebasis with regard to retaining the participant or terminating their participation.
Severe acquired brain injury.
Individual is not eligible for public mental health services due to their visastatus in Australia or for any other reason.
Any other condition that in the opinion of the research team is likely to makecompletion of the trial requirements infeasible.
Inability to understand or speak English to the extent necessary to give informedconsent and complete the trial (researcher or clinician-determined).
Study Design
Study Description
Connect with a study center
University of Melbourne
Carlton, Victoria 5053
AustraliaActive - Recruiting
Deakin University
Geelong, Victoria 3220
AustraliaActive - Recruiting
Austin Health
Heidelberg, Victoria 3084
AustraliaActive - Recruiting
Ramsay Clinic Albert Road
Melbourne, Victoria 3004
AustraliaActive - Recruiting
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