Exploring the effects of MDMA on social motivation in schizophrenia
Tolerability of MDMA in Schizophrenia
This study is testing if different doses of MDMA can help people with schizophrenia feel more motivated to engage socially and improve their quality of life.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT05770375 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the tolerability of MDMA in individuals diagnosed with schizophrenia, specifically targeting the negative symptom of asociality, which significantly impairs social functioning. Participants aged 18-60 will receive varying doses of MDMA (40mg, 80mg, or 120mg) to assess its effects on social motivation and engagement. The study aims to determine if MDMA can enhance social interactions and improve the quality of life for patients suffering from this debilitating symptom. The trial is designed for clinically stable patients who have not experienced recent hospitalizations or medication changes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 with a DSM-5 diagnosis of schizophrenia who are clinically stable.
Not a fit: Patients with a history of aggressive behavior, substance use disorders, or significant neurological or cardiovascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel treatment option for enhancing social motivation in patients with schizophrenia.
How similar studies have performed: While MDMA has shown promise in treating other psychiatric conditions like PTSD, its application for enhancing social motivation in schizophrenia is novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Los Angeles, California
- UCLA — Los Angeles, California, United States (Recruiting)
Study contacts
- Study coordinator: Gerard De Vera
- Email: gdevera@mednet.ucla.edu
- Phone: 310-794-5577
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.