MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial.

This multi-site, randomized, double-blind, confirmatory phase 3 study evaluated the efficacy and safety of 3,4-methylenedioxymethamphetamine-assisted therapy (MDMA-AT) versus placebo with identical therapy in participants with moderate to severe post-traumatic stress disorder (PTSD). Changes in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total severity score (primary endpoint) and Sheehan Disability Scale (SDS) functional impairment score (key secondary endpoint) were assessed by blinded independent assessors. Participants were randomized to MDMA-AT (n = 53) or placebo with therapy (n = 51).

MDMA-Assisted Therapy for Severe PTSD: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study.

Post-traumatic stress disorder (PTSD) presents a major public health problem for which currently available treatments are modestly effective. We report the findings of a randomized, double-blind, placebo-controlled, multi-site phase 3 clinical trial (NCT03537014) to test the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of patients with severe PTSD, including those with common comorbidities such as dissociation, depression, a history of alcohol and substance use disorders, and childhood trauma. After psychiatric medication washout, participants ( = 90) were randomized 1:1 to receive manualized therapy with MDMA or with placebo, combined with three preparatory and nine integrative therapy sessions.

MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study.

Post-traumatic stress disorder (PTSD) presents a major public health problem for which currently available treatments are modestly effective. We report the findings of a randomized, double-blind, placebo-controlled, multi-site phase 3 clinical trial (NCT03537014) to test the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of patients with severe PTSD, including those with common comorbidities such as dissociation, depression, a history of alcohol and substance use disorders, and childhood trauma. After psychiatric medication washout, participants (n = 90) were randomized 1:1 to receive manualized therapy with MDMA or with placebo, combined with three preparatory and nine integrative therapy sessions.

The influence of veteran race and psychometric testing on veterans affairs posttraumatic stress disorder (PTSD) disability exam outcomes.

This study examined the influence of veterans' race and examiners' use of psychometric testing during a Department of Veterans Affairs posttraumatic stress disorder (PTSD) disability examination on diagnostic and service connection status outcomes. Participants were 764 veterans enrolled in a national longitudinal registry. Current and lifetime PTSD diagnostic status was determined with the Structured Clinical Interview for DSM-IV (SCID) and was compared with PTSD diagnosis conferred upon veterans by their compensation and pension (C&P) examiners as well as with ultimate Veterans Affairs (VA) PTSD service connected status.

Fidelity to the Cognitive Processing Therapy Protocol: Evaluation of Critical Elements.

The contributions of individual therapy elements to the overall efficacy of evidence-based practices for the treatment of posttraumatic stress disorder (PTSD) are not well-understood. This study first examined the extent to which theoretically important treatment components of Cognitive Processing Therapy (CPT; i.e.

Trauma Narratives: It's What You Say, Not How You Say It.

Structural and content- related features of trauma narratives of traumatic events may help explain the development of PTSD. In a sample of 35 female assault survivors, we examined the association between the structure and content of trauma narratives and PTSD and other trauma-related reactions (i.e.

The differential diagnostic accuracy of the PTSD Checklist among men versus women in a community sample.

We evaluated the specific version of the PTSD Checklist (PCL-S) as a screening tool for the recruitment of community-residing men and women with diverse trauma experiences. We administered the PCL-S via telephone in the context of participant recruitment, as well as in a laboratory setting preceding administration of the Clinician Administered PTSD Scale (CAPS), the gold standard PTSD assessment tool. In the laboratory, the PCL-S performed reasonably well for men and women, yielding overall diagnostic efficiency (ODE) values (representing percentage of cases accurately identified) of 0.