An Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD
ConditionPost Traumatic Stress Disorder
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTranscend Therapeutics
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Meets DSM-5 criteria for current PTSD diagnosis, with a symptom duration of at least 6 months.
Tried at least one pharmacological treatment for PTSD or trauma-focused psychotherapy.
Proficient in communication (verbal and reading) to complete interviews and written questionnaires.
Free from any other clinically significant illness or disease.
Disqualifiers
Primary diagnosis of any other DSM-5 disorder.
Body mass index (BMI) <18kg/m2 or ≥40 kg/m2.
Unable to refrain from nicotine use for at least 8 hours.
Use of prohibited concomitant medications or therapies.
Trial design
Design model
Parallel
Treatments tested in this trial
TSND-201
DrugTSND-201 capsules, given orally, once a week for four consecutive weeks
Placebo
DrugPlacebo capsules, given orally, once a week for four consecutive weeks
Treatment groups
300 Participants
are divided into 3 treatment groupsGroup A: TSND-201, Dose Level 1Experimental treatment 1 intervention
Group B: TSND-201, Dose Level 2Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score
CAPS-5 is a structured interview designed to assess PTSD symptoms severity. The total severity score ranges from 0 to 80, with a higher score indicating more severe symptoms.
Time frame
Up to 12 WeeksSponsors and contacts
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Source ClinicalTrials.gov