NCT05770375 Tolerability of MDMA in Schizophrenia
| NCT ID | NCT05770375 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Anya Bershad, MD, PhD |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2024-09-01 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 social bonding hormone, oxytocin. MDMA has shown promise in other psychiatric conditions such as PTSD. Thus, MDMA could offer a unique therapeutic benefit in patients with SCZ who suffer from impaired social motivation. The investigators plan to take the first step in testing MDMA as a treatment for these social deficits by testing the tolerability of the drug in patients with SCZ. This will be an open-label, ascending-dose, within-subject trial in which participants will receive 40mg, 80mg, or 120mg of MDMA. The doses will be administered in ascending order, but doses will be stopped if subjects experience moderate or greater psychotic symptoms at 24 hours. This trial will assess the tolerability of the drug in this population and guide in the selection of a maximum well-tolerated dose for future studies. The primary tolerability measure will be clinician-rated psychotic symptoms (disorganized speech, delusions, hallucinations) collected at 24 hours after MDMA administration. The results of this project will lay the foundation for further investigations of MDMA and other psychoactive compounds as a treatment for debilitating and difficult-to-treat social deficits in schizophrenia. Future studies will examine interactions between the effects of psychoactive compounds and nonpharmacologic psychosocial interventions targeting social symptoms.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05770375 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05770375 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05770375 currently recruiting?
Yes, NCT05770375 is actively recruiting participants. Contact the research team at gdevera@mednet.ucla.edu for enrollment information.
Where is the NCT05770375 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT05770375 clinical trial?
NCT05770375 is sponsored by Anya Bershad, MD, PhD. The trial plans to enroll 20 participants.
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