Adolescents: A Prospective Single Arm Open Label Trial to Confirm Safety and Effectiveness of Prism as an Adjunct to Standard of Care in Adolescents with Post-Traumatic Stress Disorder (PTSD)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Post-traumatic Stress Disorder (ptsd)
  • Age: Between 12 Year(s) - 21 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Ages 12 to 21 years.
    2. Any gender.
    3. Diagnosis of PTSD.
    4. ≥1 year since index trauma.
    5. For candidate participants under 18 years old: Willingness and ability to provide assent, with the participant's legal guardian able and willing to provide informed consent for their study participation.
    6. For candidate participants 18-year-old and above: Willingness and ability to provide informed consent for their study participation.
    7. English speaking, writing and reading.
    8. Normal or corrected-to-normal vision and hearing.

You may not be eligible for this study if the following are true:

    1. Have completed one or more full courses of trauma-focused therapy in the past (i.e., EMDR, Prolong Exposure Therapy etc.).
    2. Diagnosis for schizophrenia, schizoaffective disorder, schizophreniform disorder, Bipolar I disorder, or delusional disorder.
    3. Diagnosis of autism spectrum requiring substantial support.
    4. Diagnosis of moderate or severe substance use disorder within the last 3 months of screening visit.
    5. Current symptom level of moderate or severe ADHD or at screening visit.
    6. Any change in- or initiation of- psychotropic medications within the past 4 weeks. At the time of recruitment, subjects must have no intention of changing their medication or psychotherapy during the study duration.
    7. Any history of suicidal behavior (i.e., actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior).
    8. Recent initiation (within the past 3 months) of cognitive-behavioral therapy or any evidence-based PTSD psychotherapy (Cognitive Processing Therapy [CPT], Prolonged Exposure [PE], Eye Movement Desensitization and Reprocessing [EMDR]). However, continuation of established maintenance supportive therapy will be permitted.
    9. Any history of brain surgery, of penetrating, neurovascular, infectious, or other major brain injury, of epilepsy, or of other major neurological abnormality (including a history of traumatic brain injury [TBI] with loss of consciousness for more than 24 hours or posttraumatic amnesia for more than 7 days).
    10. Enrollment in another interventional clinical study at screening or within 2 months prior to screening or intended enrollment within the duration of this study.
    11. Female subjects who are pregnant, nursing, or who plan to become pregnant while in the trial.



If you are registered as a volunteer, please log in to contact the study team/express interest in this study.

Contact the research team to learn more about this study.

By clicking "Contact Research Team", your contact information will be sent securely to the research staff associated with the study. You will also receive a copy of this email in your inbox, as well as other notifications to determine your participation status in the study.