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| ID | Type | Description | Link |
|---|---|---|---|
| MD Grant | Other Grant/Funding Number | MD Grant |
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A Phase 2, single-center, fixed-dose, open-label study will explore the efficacy, safety, and tolerability of a 120 mg dose of oral MDMA followed by a supplemental dose of 60 mg MDMA in conjunction with therapy in individual versus group settings for adult veterans diagnosed with PTSD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individual | Experimental |
| |
| Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MDMA | Drug | MDMA is a ring-substituted phenylisopropylamine derivative invented by the Merck pharmaceutical company in 1912. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | To assess the safety and tolerability of individual and group MDMA-assisted therapy in adult veterans with PTSD using Incidence and occurrence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) from signing of ICF until the EOS Visit. | 15 months |
| C-SSRS | Incidence of changes in suicidal ideation/behavior (measured using the Columbia-Suicide Severity Rating Scale [C-SSRS]) score at all visits from Baseline to EOS Visit. | 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Therapy | To assess the efficacy of individual vs. group MDMA-assisted therapy on symptoms of PTSD in adult participants using the change from Baseline to EOS Visit in the Clinician Administered PTSD Scale. (CAPS-5) | 15 months |
| Effect of Therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Evaluation Team | Contact | (301) 750-3401 | clinical.specialists@sunstonetherapies.com | |
| Kalisha Watkins | Contact | kalisha.watkins@sunstonetherapies.com |
| Name | Affiliation | Role |
|---|---|---|
| Manish Agarwal | Sunstone Medical, PC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunstone Therapies | Recruiting | Rockville | Maryland | 20850 | United States |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related 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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To assess the effect of individual vs. group MDMA-assisted therapy on quality of life and participant functional impairment in adult participants with PTSD using the change from baseline to EOS using the Sheehan Disability Scale. (SDS) |
| 15 months |
| Efficacy of Therapy | To assess the efficacy of individual vs. group MDMA-assisted therapy on symptoms of PTSD in adult participants using the change from Baseline to EOS Visit in the PTSD Checklist for DSM-5.(PCL-5) | 15 months |
| Efficacy of Therapy | To assess the efficacy of individual vs. group MDMA-assisted therapy on symptoms of PTSD in adult participants using the change from Baseline to EOS Visit in the State-Trait Anxiety Inventory. (STAI) | 15 months |
| Efficacy of Therapy | To assess the efficacy of individual vs. group MDMA-assisted therapy on symptoms of PTSD in adult participants using the change from Baseline to EOS Visit in the Quick Inventory of Depressive Symptomatology- Self-Report. ( QIDS-SR-16) | 15 months |
| Effect of Therapy | To assess the effect of individual vs. group MDMA-assisted therapy on quality of life and participant functional impairment in adult participants with PTSD using the change from baseline to EOS using the EQ-5D-5L. | 15 months |
| Effects of Therapy | To assess the effect of individual vs. group MDMA-assisted therapy on quality of life and participant functional impairment in adult participants with PTSD using the change from baseline to EOS using the Clinician Administered PTSD Scale. (CAPS-5) | 15 months |
| Organic Chemicals |