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New treatment option for PTSD
Official title Induction of Dreaming With EEG and Anesthesia for Post-traumatic Stress Disorder
ClinicalTrials.gov ID: NCT06577636
What this study is testing
- What it's testing
- The goal of this study is to test whether anesthesia-induced dreaming can help alleviate symptoms of PTSD in an (1) open-label trial (Phase I) and (2) double-blind, randomized controlled trial (Phase II) in a non-surgical setting. The investigators predict that inducing and sustaining a dream state prior to emergence from anesthesia will result in reduced symptoms of PTSD.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- A subject will be eligible for inclusion when all of the following criteria are met:
- Male or female, 18 to 70 years of age
- Able to read, understand, and provide written, dated informed consent prior to screening.
- Diagnosed with PTSD prior to screening, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition...
- Meet the threshold of CAPS-5 score of \>20 during screening.
You likely can't join if
- A potential participant will NOT be eligible for participation if any of the following criteria are met:
- Female who is pregnant or breastfeeding.
- Total CAPS-5 score ≤20 at either the screening.
- Current diagnosis of a Substance Use Disorder (SUD; Abuse or Dependence, as defined by DSM-V) rated "moderate" or "severe" per criteria of the SCID...
- Current diagnosis of Axis I disorders other than Dysthymic Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder...
- History of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes.
See the full eligibility criteria
- A subject will be eligible for inclusion when all of the following criteria are met:
- Male or female, 18 to 70 years of age
- Able to read, understand, and provide written, dated informed consent prior to screening.
- Diagnosed with PTSD prior to screening, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition. The diagnosis of PTSD will be made by a trained study staff member...
- Meet the threshold of CAPS-5 score of \>20 during screening.
- In sufficiently good health to proceed with a low-risk elective procedure, characterized using the American Society of Anesthesiologists (ASA) physical status classification system as Class I or II.
- If female, a status of non-childbearing potential or use of an acceptable form of birth control
- Body mass index between 17-35 kg/m2.
- A potential participant will NOT be eligible for participation if any of the following criteria are met:
- Female who is pregnant or breastfeeding.
- Total CAPS-5 score ≤20 at either the screening.
- Current diagnosis of a Substance Use Disorder (SUD; Abuse or Dependence, as defined by DSM-V) rated "moderate" or "severe" per criteria of the SCID, or Alcohol Use Disorder rated "moderate" or "severe" per SCID...
- Current diagnosis of Axis I disorders other than Dysthymic Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, Specific Phobia, or Bipolar II Disorder (unless one of these is...
- History of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes.
- History of anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified, within five years of screening.
- Any Axis I or Axis II Disorder, which at screening is clinically predominant to their PTSD or has been predominant to their PTSD at any time within six months prior to screening.
- In the judgment of the investigator, the subject is at significant risk for suicidal behavior during the course of his/her participation in the study.
- A neurological disorder
- A cardiovascular disorder
- A pulmonary/respiratory disorder
- Clinically significant liver disease
- Clinically significant kidney disease
- Symptomatic gastroesophageal reflux disease, hiatal hernia, or other gastrointestinal disorder placing patient at risk for aspiration or that would merit categorization of patient as ASA Class III or higher
- An endocrine disorder
- Any other abnormal laboratory result at the time of the screening exam that in the view of the investigator poses a risk for participation in the study.
- If, in the view of the participant's current primary mental health care provider this study poses a risk for participation (if a participant has a current mental health care provider).
- Participation in any clinical trial with an investigational drug or device that conflicts with this trial, within the past month or concurrent to study participation.
The study team makes the final eligibility decision.
Where it's taking place
- Stanford, California, United States
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stanford, California, United States. 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.