Table 1 Demographics and clinical characteristics of participants at baseline
From: MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial
Characteristic | MDMA-AT (n = 53) | Placebo with therapy (n = 51) |
|---|---|---|
Age (years), mean (s.d.) | 38.2 (11.0) | 40.0 (9.6) |
Sex assigned at birth, n (%) | ||
Male | 21 (39.6) | 9 (17.6) |
Female | 32 (60.4) | 42 (82.4) |
Ethnicity, n (%) | ||
Hispanic or Latino | 17 (32.1) | 11 (21.6) |
Not Hispanic or Latino | 36 (67.9) | 39 (76.5) |
Race, n (%) | ||
American Indian/Alaska Native | 0 | 2 (3.9) |
Asian | 5 (9.4) | 6 (11.8) |
Black or African American | 5 (9.4) | 3 (5.9) |
Native Hawaiian/Pacific Islander | 0 | 1 (2.0) |
White | 37 (69.8) | 32 (62.7) |
Multiple | 6 (11.3) | 7 (13.7) |
BMI (kg m−2), mean (s.d.) | 26.3 (5.6) | 24.7 (4.9) |
Duration of PTSD (years), mean (s.d.) | 16.3 (14.3) | 16.1 (12.4) |
Dissociative subtype of PTSD, n (%) | 13 (24.5) | 11 (21.6) |
Psychiatric disorder, n (%) | ||
Comorbid major depression | 49 (92.5) | 51 (100) |
Suicidal ideation | 44 (83.0) | 47 (92.2) |
Trauma history, n (%) | ||
Developmental trauma events | 49 (92.5) | 43 (84.3) |
Combat exposure | 9 (17.0) | 6 (11.8) |
Veteran status | 9 (17.0) | 7 (13.7) |
Multiple trauma events | 40 (75.5) | 45 (88.2) |
Pre-study PTSD medication, n (%)a | ||
Paroxetine | 1 (1.9) | 1 (2.0) |
Sertraline | 15 (28.3) | 10 (19.6) |
Pre-study therapy, n (%) | ||
Cognitive behavioral therapy | 15 (28.3) | 14 (27.5) |
Cognitive processing therapy | 1 (1.9) | 1 (2.0) |
Dialectical behavioral therapy | 4 (7.5) | 2 (3.9) |
Eye movement desensitization reprocessing | 17 (32.1) | 18 (35.3) |
Group therapy | 9 (17.0) | 15 (29.4) |
Holotropic breathwork | 0 | 3 (5.9) |
Prolonged exposure therapy | 2 (3.8) | 0 |
Psychodynamic therapy | 15 (28.3) | 11 (21.6) |
Other | 41 (77.4) | 42 (82.4) |
Baseline CAPS-5 total severity score, mean (s.d.) | 39.4 (6.6) | 38.7 (6.7) |
Baseline PTSD severity, n (%) | ||
Moderate (CAPS-5 score 28–34) | 13 (24.5) | 15 (29.4) |
Severe (CAPS-5 score ≥35) | 40 (75.5) | 36 (70.6) |
Baseline C-SSRS score, mean (s.d.) | ||
Suicidal ideation | 0.4 (0.8) | 0.3 (0.6) |
Ideation intensity | 3.0 (5.5) | 2.8 (5.3) |
Baseline BDI-II total score, mean (s.d.) | 25.4 (11.9) | 25.5 (11.3) |
ACE questionnaire score, mean (s.d.) | 4.8 (2.9) | 4.5 (2.7) |
Prior report of MDMA use, n (%) | ||
Lifetime reported use | 22 (41.5) | 26 (51.0) |
Reported use in the past 10 years | 13 (24.5) | 18 (35.3) |
