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MDMA Tolerability in Schizophrenia Study

This study is looking at how well MDMA (3,4-methylenedioxymethamphetamine) is tolerated in people with schizophrenia. Researchers are interested in MDMA because it might help with social motivation, a symptom of schizophrenia that current medications don't treat effectively. You might be able to join if you are 18-60 years old, have a diagnosis of schizophrenia, and have been clinically stable (no hospitalizations or medication changes) for six months. The study will measure how MDMA affects symptoms like disorganized speech, delusions, and hallucinations 24 hours after each dose. The study plans to enroll 20 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 20 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will measure symptoms 24 hours after each drug session.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05770375

Tolerability of MDMA in Schizophrenia

Recruiting
PHASE1Ages 18–60InterventionalTreatment
Anya Bershad, MD, PhD
~20 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:MDMA 40mgMDMA 80mgMDMA 120mg

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Positive and Negative Syndrome Scale for Schizophrenia (PANSS): Disorganized speech.
Measured over 24 hours after each drug session
+2 more outcomes measured

Conditions

Schizophrenia

Explore related trials

Schizophrenia

Where it's being run

1 sites across 1 states
California1

Who to contact

Gerard De Vera
[email protected]
310-794-5577
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS): Disorganized speech.24 hours after each drug session

    The PANSS is a validated 30-item clinician-administered scale assessing symptom severity in SCZ. It is widely used to assess the efficacy of antipsychotic medications. Symptoms are rated from 1 (not present) to 7 (extremely severe). The PANSS will be administered at the first session, before drug administration at each drug session, and 24 hours after each drug session. Our primary tolerability outcome measure will be clinician-rated psychotic symptoms on the three core DSM-V symptoms of psychosis (disorganized speech, delusions, hallucinations) on the PANSS 24 hours after each drug session. This is the item assessing disorganized speech.

  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS): Delusions24 hours after each drug session

    The PANSS is a validated 30-item clinician-administered scale assessing symptom severity in SCZ. It is widely used to assess the efficacy of antipsychotic medications. Symptoms are rated from 1 (not present) to 7 (extremely severe). The PANSS will be administered at the first session, before drug administration at each drug session, and 24 hours after each drug session. Our primary tolerability outcome measure will be clinician-rated psychotic symptoms on the three core DSM-V symptoms of psychosis (disorganized speech, delusions, hallucinations) on the PANSS 24 hours after each drug session. This is the item assessing delusions.

  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS): Hallucinations24 hours after each drug session

    The PANSS is a validated 30-item clinician-administered scale assessing symptom severity in SCZ. It is widely used to assess the efficacy of antipsychotic medications. Symptoms are rated from 1 (not present) to 7 (extremely severe). The PANSS will be administered at the first session, before drug administration at each drug session, and 24 hours after each drug session. Our primary tolerability outcome measure will be clinician-rated psychotic symptoms on the three core DSM-V symptoms of psychosis (disorganized speech, delusions, hallucinations) on the PANSS 24 hours after each drug session. This is the item assessing hallucinations.