Schizophrenia study: MDMA
Official title Tolerability of MDMA in Schizophrenia
ClinicalTrials.gov ID: NCT05770375
What this study is testing
What is MDMA 40mg?
This is an investigational medicine being studied to see if it can help with social motivation issues in people with schizophrenia. It is designed to increase feelings of empathy and closeness with others by affecting brain chemicals involved in social bonding.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out if MDMA is tolerable in people with schizophrenia and to identify a safe dose for future research.
- Who it's for
- Adults who have been diagnosed with schizophrenia.
- What's involved
- Participants will take 40 mg, then 80 mg, then 120 mg of MDMA in order, one dose at a time. After each dose, a clinician will check for worsening psychotic symptoms 24 hours later.
- Time commitment
- The study lasts a few weeks, with several visits for dosing and monitoring. Each dose is followed by a 24‑hour observation period before the next dose is given.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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...
You likely can't join if
- 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...
- no substance or alcohol use disorder in the past six months
- no sedatives or benzodiazepines within 24 hours of testing
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.