RETRACTED ARTICLE: MDMA-assisted psychotherapy for treatment of PTSD: study design and rationale for phase 3 trials based on pooled analysis of six phase 2 randomized controlled trials
Pourquoi ce travail est-il dans la base ?
Une base qui oublie comment elle a trouvé un travail ne peut pas être vérifiée. Voici les voies qui ont admis celui-ci.
Dossier post-publication
- Nature
- Retraction
- Motif
- Concerns/Issues about Data;Concerns/Issues about Human Subject Welfare;Conflict of Interest;Ethical Violations by Author;Investigation by Journal/Publisher;Lack of IRB/IACUC Approval and/or Compliance;Objections by Author(s);
- Date
- 8/10/2024 0:00
- Signalé par OpenAlex ?
- Oui
Source : Retraction Watch, jointe par DOI. OpenAlex consigne la rétractation dans is_retracted, un booléen sur un espace d'états à au moins quatre valeurs ; il ne peut donc exprimer ni une expression de préoccupation, ni une correction, ni un rétablissement, et les rapporte comme false, ce qui se lit comme « rien à signaler ».
Résumé
BACKGROUND: Posttraumatic stress disorder is a prevalent mental health condition with substantial impact on daily functioning that lacks sufficient treatment options. Here we evaluate six phase 2 trials in a pooled analysis to determine the study design for phase 3 trials of MDMA-assisted psychotherapy for PTSD. METHODS: Six randomized, double-blind, controlled clinical trials at five study sites were conducted from April 2004 to February 2017. Active doses of MDMA (75-125 mg, n = 72) or placebo/control doses (0-40 mg, n = 31) were administered to individuals with PTSD during manualized psychotherapy sessions in two or three 8-h sessions spaced a month apart. Three non-drug 90-min therapy sessions preceded the first MDMA exposure, and three to four followed each experimental session. RESULTS: After two blinded experimental sessions, the active group had significantly greater reductions in CAPS-IV total scores from baseline than the control group [MMRM estimated mean difference (SE) between groups - 22.0 (5.17), P < 0.001]. The between-group Cohen's d effect size was 0.8, indicating a large treatment effect. After two experimental sessions, more participants in the active group (54.2%) did not meet CAPS-IV PTSD diagnostic criteria than the control group (22.6%). Depression symptom improvement on the BDI-II was greatest for the active group compared to the control group, although only trended towards significant group differences [MMRM, estimated mean difference (SE) between groups - 6.0 (3.03), P = 0.053]. All doses of MDMA were well tolerated, with some expected reactions occurring at greater frequency for the active MDMA group during experimental sessions and the 7 days following. CONCLUSIONS: MDMA-assisted psychotherapy was efficacious and well tolerated in a large sample of adults with PTSD. These studies supported expansion into phase 3 trials and led to FDA granting Breakthrough Therapy designation for this promising treatment. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00090064, NCT00353938, NCT01958593, NCT01211405, NCT01689740, NCT01793610.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
La notice
- Revue
- Psychopharmacology
- Thématique
- Psychedelics and Drug Studies
- Domaine
- Psychology
- Établissements canadiens
- Okanagan University CollegeUniversity of British Columbia, Okanagan CampusUniversity of British Columbia
- Organismes subventionnaires
- —
- Mots-clés
- MDMARandomized controlled trialPsychologyPsychotherapistPsychiatryResearch designClinical psychologyMedicineInternal medicine
- Résumé présent dans OpenAlex
- oui