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This is an extension study of participants who previously completed a Transcend-sponsored clinical trial evaluating TSND-201 as a treatment for PTSD.
Participants will be followed for up to 52 weeks. During the 52 week period, PTSD symptoms and safety will be assessed monthly.
Participants' PTSD symptoms will be assessed at each observational visit and if criteria for Relapse has been met, participants may be eligible to receive a course of TSND-201 treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (Methylone) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylone | Drug | A course of treatment includes 4 weekly doses of TSND-201. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Clinician Administered PTSD Scale for DSM-5 (CAPS-5) total severity score | The CAPS-5 is a structured interview designed to assess PTSD symptom severity. The total severity score ranges from 0 to 80, with a higher score indicating more severe symptoms. | Up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of serious adverse events (SAEs), adverse events of special interest (AESIs), and treatment-emergent adverse events (TEAEs) | Types and rates of adverse events | Up to 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mountain View Clinical Research | Denver | Colorado | 80209 | United States | ||
| Sunstone Medical |
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| Rockville |
| Maryland |
| 20850 |
| United States |
| Cedar Clinical Research, Inc | Draper | Utah | 84020 | United States |
| La Nua Mental Health Centre | Galway | Ireland |
| Cambridgeshire and Peterborough NHS Foundation Trust | Cambridge | England | United Kingdom |
| Mirabilis Health | Belfast | Northern Ireland | United Kingdom |
| NHS Greater Glasgow and Clyde | Glasgow | Scotland | United Kingdom |
| Clerkenwell Health | London | United Kingdom |
| Kings College | London | United Kingdom |
| 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 |
|---|---|
| C400939 | methylone |
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