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Tolerability of MDMA in Schizophrenia

RecruitingPhase 1, Phase 2Ages 18 Years - 60 YearsAllAnya Bershad, MD, PhD
NCT05770375 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Impaired social motivation, or "asociality," is a negative symptom of schizophrenia (SCZ) and a cause of significant functional impairment in the illness. Whereas many symptoms of schizophrenia can be treated with antipsychotic medications, deficits in social motivation persist, leading to significant social disability in patients. There is currently no effective treatment for this symptom of the illness. One promising and unexplored avenue to enhance social motivation in schizophrenia is ± 3,4-methylenedioxymethamphetamine (MDMA). MDMA is a psychostimulant that shares some pharmacological properties with amphetamines, but in addition, has pronounced pro-social effects, increasing the motivation to engage socially. In healthy volunteers, it produces feelings of empathy and closeness with others and increases attention to positive social cues, perhaps partly through its effects on the soc

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📋 Eligibility rules (as published)
Inclusion Criteria: * Ages 18-60 * able to understand spoken English sufficiently to comprehend testing procedures * DSM-5 diagnosis of schizophrenia, based on clinical interview * clinical stability (i.e., no inpatient hospitalizations for six months prior to enrollment, no changes in medication in for 6 months prior to enrollment) Exclusion Criteria: * no history of aggressive or suicidal behavior while psychotic * no history of IQ less than 70 or developmental disability, based on medical history * no clinically significant neurological disease (e.g., epilepsy), or cardiovascular condition (e.g. cardiac arrhythmia) based on medical history * no history of serious head injury (i.e., loss of consciousness longer than 1 hour, neuropsychological sequelae, cognitive rehabilitation treatment after head injury) based on medical history * no substance or alcohol use disorder in the past six months * no sedatives or benzodiazepines within 24 hours of testing * no positive urine toxicology screen or visible intoxication on the day of assessment * no women who are pregnant or think that they might be pregnant, based on self-report and urine test * not currently taking SSRIs or SNRIs * no history of NMS or serotonin syndrome * No prolongation of the QTc interval on EKG
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What it tests

  • MDMA 40mg
  • MDMA 80mg
  • MDMA 120mg
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Where

1 site
UCLA
Los Angeles, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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