NCT05012709 - 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)

American Psychiatric Association
(2013). Quick reference to the diagnostic criteria from DSM-V (p. 370). Washington, DC: APA.
Cheng SC, Hsu WS, Shen SH, Hsu MC, Lin MF
Dose-Response Relationships of Multisensory Intervention on Hospitalized Patients With Chronic Schizophrenia. J Nurs Res. 2017 Feb;25(1):13-20. doi: 10.1097/jnr.0000000000000154.
Juszczak E, Altman DG, Hopewell S, Schulz K
Reporting of Multi-Arm Parallel-Group Randomized Trials: Extension of the CONSORT 2010 Statement. JAMA. 2019 Apr 23;321(16):1610-1620. doi: 10.1001/jama.2019.3087.
Michultka DM, Poppen RL, Blanchard EB
Relaxation training as a treatment for chronic headaches in an individual having severe developmental disabilities. Biofeedback Self Regul. 1988 Sep;13(3):257-66.
Overall, J
E., & Gorham, D. R. (1962). The brief psychiatric rating scale. Psychological reports, 10(3), 799-812. https://doi.org/10.2466%2Fpr0.1962.10.3.799
Schulz KF, Altman DG, Moher D; CONSORT Group
CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Trials. 2010 Mar 24;11:32. doi: 10.1186/1745-6215-11-32.
Snaith RP
The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29.

Developing a Healthy Care Environment in Psychiatry: A Study of Dose-response Relationship and the Evidence Based Multisensory Stimulation Intervention

Details for clinical trial NCT05012709

Clinical trial NCT05012709 - References