NCT04323566 - 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)

Attwells S, Setiawan E, Wilson AA, Rusjan PM, Mizrahi R, Miler L, Xu C, Richter MA, Kahn A, Kish SJ, Houle S, Ravindran L, Meyer JH
Inflammation in the Neurocircuitry of Obsessive-Compulsive Disorder. JAMA Psychiatry. 2017 Aug 1;74(8):833-840. doi: 10.1001/jamapsychiatry.2017.1567.
Brimberg L, Benhar I, Mascaro-Blanco A, Alvarez K, Lotan D, Winter C, Klein J, Moses AE, Somnier FE, Leckman JF, Swedo SE, Cunningham MW, Joel D
Behavioral, pharmacological, and immunological abnormalities after streptococcal exposure: a novel rat model of Sydenham chorea and related neuropsychiatric disorders. Neuropsychopharmacology. 2012 Aug;37(9):2076-87. doi: 10.1038/npp.2012.56. Epub 2012 Apr 25.
Dazzi F, Shafer A, Lauriola M
Meta-analysis of the Brief Psychiatric Rating Scale - Expanded (BPRS-E) structure and arguments for a new version. J Psychiatr Res. 2016 Oct;81:140-51. doi: 10.1016/j.jpsychires.2016.07.001. Epub 2016 Jul 4. Review.
Debnath M, Venkatasubramanian G
Recent advances in psychoneuroimmunology relevant to schizophrenia therapeutics. Curr Opin Psychiatry. 2013 Sep;26(5):433-9. doi: 10.1097/YCO.0b013e328363b4da. Review.
Lee WJ, Lee ST, Byun JI, Sunwoo JS, Kim TJ, Lim JA, Moon J, Lee HS, Shin YW, Lee KJ, Kim S, Jung KH, Jung KY, Chu K, Lee SK
Rituximab treatment for autoimmune limbic encephalitis in an institutional cohort. Neurology. 2016 May 3;86(18):1683-91. doi: 10.1212/WNL.0000000000002635. Epub 2016 Apr 1.

A Randomized, Double-blinded, Placebo-controlled Study of Rituximab in Patients With Psychosis and/or Obsessive Compulsive Disorder, With an Indication of Immune System Involvement

Details for clinical trial NCT04323566

Clinical trial NCT04323566 - References