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Behavioural Intervention
Anesthesia-Induced Dreaming for PTSD (IDEA_PTSD Trial)
Phase 2
Waitlist Available
Led By Boris D Heifets, MD, PhD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with PTSD prior to screening, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, supported by the Structured Clinical Interview for DSM Disorders (SCID)
If female, status of non-childbearing potential or use of an acceptable form of birth control
Must not have
History of schizophrenia, schizoaffective disorders, or psychotic symptoms in depressive episodes
Clinically significant liver disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month post-intervention
Summary
This trial aims to test if anesthesia-induced dreaming can help reduce symptoms of PTSD. Participants will be split into two groups - one that will experience dreaming during anesthesia and one that will not.
Who is the study for?
This trial is for individuals with Post-Traumatic Stress Disorder (PTSD). Participants should be healthy enough to undergo anesthesia. Specific details about inclusion and exclusion criteria are not provided, but typically these would outline who can or cannot participate based on health conditions, medications, or other factors.
What is being tested?
The study is testing if using Propofol anesthesia to induce dreams can help reduce PTSD symptoms. It's a Phase II trial where participants are split into two groups: one experiences induced dreaming ('Dream Group'), while the other does not ('No-Dream group'). The allocation is random and both participants and researchers do not know who is in which group (double-blind).
What are the potential side effects?
While specific side effects of the intervention are not listed here, generally Propofol anesthesia may cause reactions such as pain at injection site, low blood pressure, drowsiness after waking up, and in rare cases more serious effects like allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with PTSD by a professional.
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I am not able to have children or I am using reliable birth control.
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I am between 18 and 70 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of schizophrenia or related disorders.
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I have a serious liver condition.
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I have a serious kidney condition.
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I have severe acid reflux, hiatal hernia, or another serious stomach condition.
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I am currently pregnant or breastfeeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month post-intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month post-intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Secondary study objectives
Number of Participants With Clinical Response
Number of Participants With Remission
PTSD Checklist for DSM-5 (PCL-5)
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Dream GroupActive Control1 Intervention
Dream Group (n=21) will be subjected to an anesthetic protocol resulting in dream experiences during anesthesia.
Group II: No-Dream GroupPlacebo Group1 Intervention
No-Dream Group (n=21) will be subjected to an anesthetic protocol resulting in no dream experiences during anesthesia.
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,491 Previous Clinical Trials
17,519,170 Total Patients Enrolled
Tiny Blue Dot FoundationUNKNOWN
9 Previous Clinical Trials
616 Total Patients Enrolled
Boris D Heifets, MD, PhDPrincipal InvestigatorStanford University
1 Previous Clinical Trials
45 Total Patients Enrolled