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הניסוי הקליני NCT07288151 עבור הפרעת דחק פוסט-טראומטית הוא טרם החל גיוס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן. | ||
מחקר אחד תואם לקריטריוני המסנן
תצוגת כרטיסים
חזרה לחיפוש
אוניברסיטת אמוריMDMA-Assisted Massed Exposure Therapy for PTSD שלב II 200 אקראי מבוקר פלסבו
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
הניסוי הקליני NCT07288151 מתוכנן לבדוק את טיפול עבור הפרעת דחק פוסט-טראומטית. זהו מחקר שלב II מסוג התערבותי שנמצא במצב טרם החל גיוס. גיוס המשתתפים צפוי להתחיל ב-1 בינואר 2026, במטרה לכלול 200 משתתפים. המחקר ינוהל על ידי אוניברסיטת אמורי וצפוי להסתיים ב-1 בינואר 2030. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-17 בדצמבר 2025.
סיכום קצר
The goal of this clinical trial is to investigate the efficacy of 3,4-methylenedioxy-methamphetamine hydrochloride (MDMA) combined with Massed Prolonged Exposure (PE) therapy for the treatment of posttraumatic stress disorder (PTSD) in adult participants diagnosed with PTSD. This randomized, placebo-controlled trial will enroll 95 participants.
The main questions it aims to answer are:
- Does the combination of PE ...
תיאור מפורט
Posttraumatic stress disorder (PTSD) affects many individuals, including military veterans and civilians exposed to trauma. While trauma-focused therapies like Prolonged Exposure (PE) are effective, many people do not fully recover, and current medications often have limited success.
This study will test whether combining PE therapy with a single dose of MDMA (a psychoactive drug) can improve PTSD treatment outcomes...
הצג עודכותרת רשמית
MDMA-Assisted Massed Exposure Therapy for PTSD
מצבים רפואיים
הפרעת דחק פוסט-טראומטיתמזהי מחקר נוספים
- 2025P012039
- TP240376 (מזהה אחר) (DOD)
מספר NCT
תחילת המחקר (בפועל)
2026-01
עדכון אחרון שפורסם
2025-12-17
סיום המחקר (מוערך)
2030-01
משתתפים (מתוכנן)
200
סוג המחקר
התערבותי
שלב
שלב II
סטטוס
טרם החל גיוס
מילות מפתח
MDMA
3,4-Methylenedioxymethamphetamine
Massed prolonged exposure therapy
Pos traumatic stress disorder
3,4-Methylenedioxymethamphetamine
Massed prolonged exposure therapy
Pos traumatic stress disorder
מטרה ראשית
טיפול
הקצאת טיפול
אקראי
דגם מתערב
קבוצות מקבילות
עיוורון
משולש
זרועות / התערבויות
| קבוצת משתתפים/זרוע | התערבות/טיפול |
|---|---|
ניסיMDMA group | 3,4-Methylenedioxymethamphetamine (MDMA) MDMA is a synthetic compound, commonly administered as MDMA hydrochloride (HCl).
The drug will be administered in 100mg doses for a single session on Visit 2 out of 10- day study sessions over 2 weeks. MDMA is administered orally in capsule form and is taken under supervision in a controlled, therapeutic environment Massed Prolonged Exposure (PE) Massed exposure therapy will be conducted for 11 sessions, 10 daily sessions and an additional therapy session during V2. They will consist of repeated exposures to trauma memories (imaginal exposure) consistent with the manualized protocol for massed exposure therapy.
Also consistent with this treatment manual, participants will listen to imaginal exposures outside of PE sessions for "homework." |
פלצבו להשוואהStandard of Care | פלצבו Placebos will visually match the 3 MDMA capsules (40mg, 40mg, and 20mg). Massed Prolonged Exposure (PE) Massed exposure therapy will be conducted for 11 sessions, 10 daily sessions and an additional therapy session during V2. They will consist of repeated exposures to trauma memories (imaginal exposure) consistent with the manualized protocol for massed exposure therapy.
Also consistent with this treatment manual, participants will listen to imaginal exposures outside of PE sessions for "homework." |
מדדי תוצאה ראשיים
מדדי תוצאה משניים
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
Changes in PTSD symptoms measured by CAPS-5-R | The CAPS-5-R is a structured clinical interview used to assess PTSD symptoms based on DSM-5 criteria. Each symptom is rated on frequency and intensity
* Combined into a severity score per item
* Total score reflects overall PTSD symptom severity | Baseline, 1 month post-treatment |
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
Changes in PTSD symptoms measured by PCL-5 | The PCL-5 is a 20-item self-report questionnaire used to measure PTSD symptoms based on DSM-5 criteria. Participants rate how much they've been bothered by each symptom in relation to a specific traumatic event, using a scale from 0 ("Not at all") to 4 ("Extremely"). A total score of 33 or higher indicates clinically elevated PTSD symptoms | Baseline, 1 month post treatment |
Change in PHQ questionnaire scores | The PHQ-9 is a questionnaire used to assess depression severity. Each of the 9 items is scored from 0 to 3, giving a total score between 0 and 27.
Higher scores suggest more severe depressive symptoms. | Baseline, 1 month post-treatment |
עוזר השתתפות
קריטריוני זכאות
גילאים מוערכים למחקר
מבוגר, גיל שלישי
גיל מינימלי למחקר
21 Years
מגדרים מוערכים למחקר
הכל
- PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale for DSM-5 - Revised (CAPS-5-R).
- Able to speak and read English (due to standardization of outcome measures).
- Willing to sign a release for the investigators to communicate with their primary care or mental health providers if indicated.
- Able to swallow pills.
- Agree to have study visits video and/or audio recorded, including Experimental Session, assessments, and non-drug therapy sessions.
- Willing to provide a contact (relative, spouse, close friend, or another support person) who is willing and able to be contacted by the investigators.
- Agree to inform the investigators within 48 hours of any medical conditions and procedures.
- If able to become pregnant, must have a negative pregnancy test before study entry, at study entry, and before the Medicine Session. Must agree to use adequate birth control for a month before the Medicine session and through 10 days after the Medicine Session.
- Agree to the following lifestyle modifications: comply with requirements for fasting and refraining from certain medications before the Medicine Session, and not participating in any other interventional clinical trials during the duration of the study, are driven home or to a hotel after the Medicine Session, and commit to medication dosing, therapy, and study procedures
- Are not able to give adequate informed consent.
- Have previously participated in a Multidisciplinary Association for Psychedelic Studies (MAPS) sponsored MDMA clinical trial.
- Have any current problem which, in the opinion of the investigator or study physician, might interfere with participation.
- Have hypersensitivity to any ingredient of the Investigational Medicinal Product (IMP).
- Upon review of medical or psychiatric history and psychiatric assessment, have any current or past diagnosis that would be considered a risk to participating in the study
- Requires ongoing psychiatric medication use with certain exceptions. Individuals may decide to taper psychiatric medications under the guidance of their local provider.
- Have a history of any medical condition that could make receiving MDMA dangerous because of increases in blood pressure and heart rate or any medical condition the study physician believes would pose a safety risk or interfere with the effects of the treatment. Any medical disorder judged by the investigator to significantly increase the risk of MDMA administration by any mechanism is exclusionary.
- Have any unstable medical condition that would interfere with participation.
- Have uncontrolled hypertension) documented on three separate occasions.
- Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.
- Have a history of ever having ventricular arrhythmia or any other abnormal heart rhythm that the study physician believes would pose a significant risk of participation.
- Have an abnormal finding on electrocardiogram
- Have a history of additional risk factors for Torsade de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
- Require the use of concomitant medications that could impact the effects or safety of MDMA during the Medicine Session.
- Have symptomatic liver disease or significant liver enzyme elevations.
- Have a history of hyponatremia or hyperthermia.
- Weigh less than 48 kilograms (105 lbs.).
- Are pregnant or nursing
- Have engaged in ketamine-assisted therapy or used ketamine within 12 weeks of enrollment
אוניברסיטת אמוריUnited States Department of Defenseהגורם האחראי למחקר
Jessica Maples-Keller, חוקר ראשי, Associate Professor, Emory University
איש קשר מרכזי למחקר
איש קשר: Jessica Maples-Keller, PhD, 404-778-2075, [email protected]
איש קשר: Syreese Fuller, [email protected]
1 מיקומי המחקר ב-1 מדינות
Georgia
Emory Brain Health Center, Atlanta, Georgia, 30329, United States
Jessica Maples-Keller, PhD, איש קשר, 404-778-2075, [email protected]