Software as a Medical Device for the Treatment of Patients With PTSD
Recruiting
Phase 2
Phase 3
Interventional Study
Post-Traumatic Stress Disorder, PTSD
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 52 (estimated)
- Sponsor
- Otsuka Medical Devices Co., Ltd. Japan · Industry
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About This Trial
To evaluate the efficacy and safety of Software as a Medical Device in patients with Post-Traumatic Stress Disorder (PTSD)
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Diagnosis of PTSD according to the DSM-5
* Subjects who are within 1 to 20 years since index trauma
Exclusion Criteria:
* Subjects diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, bipolar I disorder, autism spectrum diso…
Contacts