An Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD

Conditions

• Post Traumatic Stress Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• TSND-201 — DRUG
  TSND-201 capsules, given orally, once a week for four consecutive weeks
• Placebo — DRUG
  Placebo capsules, given orally, once a week for four consecutive weeks

Study Details

This study is evaluating the safety and efficacy of TSND-201 in adults with PTSD. Eligible participants will enter a 4-week Treatment Period where they will be randomized 1:1:1 to receive one of two doses of TSND-201 or placebo, once per week. Following the Treatment Period, participants will enter an 8-week Follow-up Period.

Key Dates

First listed

Sep 23, 2026

Start date

Sep 30, 2026

Status verified

Sep 2026

Primary completion

Feb 29, 2028

Completion

Feb 29, 2028

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: TSND-201, Dose Level 1
• Experimental: TSND-201, Dose Level 2
• Placebo Comparator: Placebo

Primary Outcome Measure

Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score [ Time Frame: Up to 12 Weeks ]

Central Contacts

• Study Director
  650-769-6472
  [email protected]

Locations (2)

Find similar trials in Denver, CO

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