NCT05766241 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Jackson CE, Ciarleglio MM, Aslan M, Marx BP, Ko J, Concato J, Proctor SP, Vasterling JJ
Associations Among Increases in Posttraumatic Stress Symptoms, Neurocognitive Performance, and Long-Term Functional Outcomes in U.S. Iraq War Veterans. J Trauma Stress. 2021 Jun;34(3):628-640. doi: 10.1002/jts.22663. Epub 2021 Mar 2.
Regier DA, Kuhl EA, Kupfer DJ
The DSM-5: Classification and criteria changes. World Psychiatry. 2013 Jun;12(2):92-8. doi: 10.1002/wps.20050.
Watkins LE, Sprang KR, Rothbaum BO
Treating PTSD: A Review of Evidence-Based Psychotherapy Interventions. Front Behav Neurosci. 2018 Nov 2;12:258. doi: 10.3389/fnbeh.2018.00258. eCollection 2018.

Investigating the Feasibility and Efficacy of a Novel Sensory-based Psychoeducation Program for Military Veterans With Posttraumatic Stress Disorder

Clinical trial NCT05766241 - References