Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06412757
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-09
Brief Title:
Silexan in the Treatment Of Posttraumatic Stress Disorder Trial
Sponsor:
Deakin University
Organization:
Deakin University
Study Overview
Official Title:
Silexan in the Treatment Of Posttraumatic Stress Disorder STOP Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STOP
Brief Summary:
Posttraumatic stress disorder PTSD is a common and debilitating mental illness Current treatments for PTSD include psychotherapy and antidepressant medications Many patients are unable to tolerate psychotherapy for PTSD and drop out of it In addition its effectiveness is limited Up to 50 percent of patients who receive psychotherapy do not benefit from it Antidepressant medications have only small benefits in PTSD They also have unpleasant side effects that can make patients unwilling to take them There is an urgent need to develop new treatments for PTSD that work and are well-tolerated Silexan has the potential to provide an important alternative treatment for PTSD
Silexan is derived from lavender oil It is taken orally in the form of capsules It is currently available over-the-counter in 14 countries including Australia and the United States Previous research has shown that it is an effective treatment for anxiety disorders including Generalized Anxiety Disorder It is also well-tolerated by patients The only side effects that have been identified so far are mild gastrointestinal symptoms including burping and breath odour and these are uncommon The results of a small pilot study suggest that Silexan may also be effective and well-tolerated in PTSD
The STOP trial is a clinical trial that aims to investigate whether adding Silexan to treatment-as-usual improves PTSD symptoms in adults with PTSD The trial will recruit 224 participants Participants will be randomly assigned to take Silexan or a placebo look-alike dummy pills daily in addition to their usual medications for 12 weeks The severity of their PTSD symptoms will be assessed prior to and at the end of this 12-week period
The STOP trial has the potential to obtain definitive evidence regarding whether Silexan helps treat symptoms of PTSD If Silexan is found to be an effective treatment for PTSD the pool of patients who could potentially benefit from this treatment includes any adults with PTSD Silexan is already available over-the-counter at a relatively low cost so there will be few barriers to accessing this treatment
Silexan is derived from lavender oil It is taken orally in the form of capsules It is currently available over-the-counter in 14 countries including Australia and the United States Previous research has shown that it is an effective treatment for anxiety disorders including Generalized Anxiety Disorder It is also well-tolerated by patients The only side effects that have been identified so far are mild gastrointestinal symptoms including burping and breath odour and these are uncommon The results of a small pilot study suggest that Silexan may also be effective and well-tolerated in PTSD
The STOP trial is a clinical trial that aims to investigate whether adding Silexan to treatment-as-usual improves PTSD symptoms in adults with PTSD The trial will recruit 224 participants Participants will be randomly assigned to take Silexan or a placebo look-alike dummy pills daily in addition to their usual medications for 12 weeks The severity of their PTSD symptoms will be assessed prior to and at the end of this 12-week period
The STOP trial has the potential to obtain definitive evidence regarding whether Silexan helps treat symptoms of PTSD If Silexan is found to be an effective treatment for PTSD the pool of patients who could potentially benefit from this treatment includes any adults with PTSD Silexan is already available over-the-counter at a relatively low cost so there will be few barriers to accessing this treatment
Detailed Description:
Background Posttraumatic stress disorder PTSD is a common and debilitating psychiatric disorder Existing PTSD treatments have very significant limitations Current evidence-based treatments for PTSD include trauma-focussed psychotherapy and antidepressant medications including selective serotonin reuptake inhibitors and the serotonin noradrenaline reuptake inhibitor venlafaxine Many patients are unable to tolerate trauma-focussed psychotherapy Uptake is relatively low and dropout rates are high In addition up to 50 of patients fail to respond to this therapy Antidepressant medications have small clinical effects and are associated with unpleasant side effects that can lead to non-adherence There is an urgent need for new treatments for PTSD that are effective and well-tolerated Silexan has the potential to provide a transformative alternative to these treatments It is an orally administered lavender oil preparation whose main constituents are the monoterpenoids linalool and linalyl acetate It is available over-the-counter in 14 countries including Australia and the United States It has a novel pharmacodynamic profile that includes potent inhibition of voltage-gated calcium channels and reduction of serotonin 1A receptor binding potential Silexan is an effective treatment for Generalized Anxiety Disorder GAD and other anxiety disorders A 2019 independent meta-analysis of data from five randomized controlled trials involving 1320 participants with anxiety disorders found that Silexan 160 mg out-performed paroxetine and lorazepam in reducing anxiety symptoms Silexan is also well-tolerated The only adverse effects that have been identified so far are mild gastrointestinal symptoms and these are uncommon Promising pilot data suggest that Silexan may also be effective and well-tolerated in PTSD
Hypothesis The primary hypothesis is that Silexan as an adjunct to treatment-as-usual over 12 weeks will be superior to placebo in improving PTSD symptoms in adults with PTSD
Specific aims The trial aims to investigate the effectiveness of adjunctive Silexan compared with placebo over 12 weeks in improving PTSD symptoms The primary outcome measure will be the between-group change from baseline in the total symptom severity score on the Clinician-Administered PTSD Scale for DSM-5 CAPS-5
Study design The trial is a phase 3 12-week multi-site parallel-arm randomized placebo-controlled double-blind trial Participants will be adults with PTSD without comorbid psychosis bipolar disorder moderate or severe substance use disorder or Borderline Personality Disorder Participants randomized to the Silexan arm will receive Silexan 160 mg daily for 12 weeks in addition to their usual prescribed medications Participants randomized to the placebo arm will receive capsules containing an inert placebo The target sample size will be 156 participants or 78 per arm The study will recruit 224 participants to account for a 30 drop-out rate
Clinical impact There is an urgent need to develop new treatments for PTSD that are effective and well-tolerated This trial has the potential to provide definitive evidence of the efficacy of Silexan in adult PTSD Silexan is safe well-tolerated currently available and affordable facilitating a rapid translation into clinical care If Silexan is found to be an effective treatment for PTSD the pool of patients who could potentially benefit from this treatment includes any adults with PTSD
Hypothesis The primary hypothesis is that Silexan as an adjunct to treatment-as-usual over 12 weeks will be superior to placebo in improving PTSD symptoms in adults with PTSD
Specific aims The trial aims to investigate the effectiveness of adjunctive Silexan compared with placebo over 12 weeks in improving PTSD symptoms The primary outcome measure will be the between-group change from baseline in the total symptom severity score on the Clinician-Administered PTSD Scale for DSM-5 CAPS-5
Study design The trial is a phase 3 12-week multi-site parallel-arm randomized placebo-controlled double-blind trial Participants will be adults with PTSD without comorbid psychosis bipolar disorder moderate or severe substance use disorder or Borderline Personality Disorder Participants randomized to the Silexan arm will receive Silexan 160 mg daily for 12 weeks in addition to their usual prescribed medications Participants randomized to the placebo arm will receive capsules containing an inert placebo The target sample size will be 156 participants or 78 per arm The study will recruit 224 participants to account for a 30 drop-out rate
Clinical impact There is an urgent need to develop new treatments for PTSD that are effective and well-tolerated This trial has the potential to provide definitive evidence of the efficacy of Silexan in adult PTSD Silexan is safe well-tolerated currently available and affordable facilitating a rapid translation into clinical care If Silexan is found to be an effective treatment for PTSD the pool of patients who could potentially benefit from this treatment includes any adults with PTSD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HT9425-23-1-0885 | OTHER_GRANT | US Department of Defense CDMRP Contract Number | None |