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| ID | Type | Description | Link |
|---|---|---|---|
| 1DP5OD036172-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MDMA | Experimental | Each subject will receive 3 doses of MDMA in ascending order: 40mg, 80mg, 120mg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MDMA 40mg | Drug | MDMA 40mg |
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| MDMA 80mg |
| Measure | Description | Time Frame |
|---|---|---|
| Positive and Negative Syndrome Scale for Schizophrenia (PANSS): Disorganized speech. | 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. | 24 hours after each drug session |
| Positive and Negative Syndrome Scale for Schizophrenia (PANSS): Delusions | 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. | 24 hours after each drug session |
| Positive and Negative Syndrome Scale for Schizophrenia (PANSS): Hallucinations | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gerard De Vera | Contact | 310-794-5577 | gdevera@mednet.ucla.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA | Recruiting | Los Angeles | California | 90025 | United States |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D018817 | N-Methyl-3,4-methylenedioxyamphetamine |
| ID | Term |
|---|---|
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 |
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Ascending-dose tolerability study
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| Drug |
MDMA 80mg |
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| MDMA 120mg | Drug | MDMA 120mg |
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| 24 hours after each drug session |
| Organic Chemicals |