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Israel Conference, Tel Aviv, 24-3-05 MDMA/PTSD research in Spain. Preliminary data and future perspectives José Carlos Bouso Saiz ( jcbouso@gmail.com ) Cátedra de la “Fundación Cultural Fórum Filatélico de Psicobiología y Discapacidad” Departamento de Psicología Biológica y de la Salud
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Israel Conference, Tel Aviv, 24-3-05 MDMA/PTSD research in Spain. Preliminary data and future perspectives José Carlos Bouso Saiz (jcbouso@gmail.com) Cátedra de la “Fundación Cultural Fórum Filatélico de Psicobiología y Discapacidad” Departamento de Psicología Biológica y de la Salud Facultad de Psicología Universidad Autónoma de Madrid 28049 Madrid Spain
DOSE-FINDING PILOT STUDY Group 1 (5 subjects): MDMA 50 mg (3 subjects) placebo (1 subject) Group 2 (7 subjects): MDMA 75 mg (5 subjects) placebo (2 subjects) Group 3 (7 subjects): 100 mg de MDMA (5 subjects) placebo (2 subjects) Group 4 (7 subjects): 125 mg de MDMA (5 subjects) placebo (2 subjects) Group 5 (5 subjects): 150 mg de MDMA (3 subjects) placebo (1 subject) TOTAL SUBJECTS: 29 (MDMA: 21; placebo: 8) EFFICACY PILOT STUDY - Group 1 (15 subjects): MDMA (the most efficacy dose obtained from the dose-finding pilot study) - Group 2 (15 subjects): placebo PROPOSED STUDY DESIGNS
Psychometric measures • A Strutured Clinical Interview based on the DSM-IV (the SCID). • The Scale of Severity of Symptoms of PTSD. • A Semi-Structured Interview regarding sexual aggression. • STAI/S. The STAI in its State version. • BDI. The Beck Depression Inventory. • HRS. The Hamilton Rating Scale for depression. • MFS-III. The Modified Fear Scale (assess specific fears related with a sexual assault). • A Maladjustment Scale. • SE/R. The Rosenger Self-Esteem Scale. • HRS-S. The Hallucinogen Rating Scale, HRS. • The UKU side-effects rating scale. • HAq. The Helping Alliance questionnaire.
OBJECTIVES • To assess the security of different doses of MDMA in chronic PTSD population • To obtain preliminary data about the efficacy of MDMA in the treatment of PTSD • To familarize the therapeutic team with the treatment with MDMA and to refine the therapeutic approach • To assess how the proposed rating scales work in order to refine them in future studies