NCT02370316 - 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)

Rossi R, Lanfredi M, Pievani M, Boccardi M, Beneduce R, Rillosi L, Giannakopoulos P, Thompson PM, Rossi G, Frisoni GB
Volumetric and topographic differences in hippocampal subdivisions in borderline personality and bipolar disorders. Psychiatry Res. 2012 Aug-Sep;203(2-3):132-8. doi: 10.1016/j.pscychresns.2011.12.004. Epub 2012 Sep 1.
Rossi R, Lanfredi M, Pievani M, Boccardi M, Rasser PE, Thompson PM, Cavedo E, Cotelli M, Rosini S, Beneduce R, Bignotti S, Magni LR, Rillosi L, Magnaldi S, Cobelli M, Rossi G, Frisoni GB
Abnormalities in cortical gray matter density in borderline personality disorder. Eur Psychiatry. 2015 Feb;30(2):221-7. doi: 10.1016/j.eurpsy.2014.11.009. Epub 2015 Jan 2.
Rossi R, Pievani M, Lorenzi M, Boccardi M, Beneduce R, Bignotti S, Borsci G, Cotelli M, Giannakopoulos P, Magni LR, Rillosi L, Rosini S, Rossi G, Frisoni GB
Structural brain features of borderline personality and bipolar disorders. Psychiatry Res. 2013 Aug 30;213(2):83-91. doi: 10.1016/j.pscychresns.2012.07.002. Epub 2012 Nov 10.
Semerari A, Cucchi M, Dimaggio G, Cavadini D, Carcione A, Battelli V, Nicolò G, Pedone R, Siccardi T, D'Angerio S, Ronchi P, Maffei C, Smeraldi E
The development of the Metacognition Assessment interview: instrument description, factor structure and reliability in a non-clinical sample. Psychiatry Res. 2012 Dec 30;200(2-3):890-5. doi: 10.1016/j.psychres.2012.07.015. Epub 2012 Aug 18.

Neuroimaging and Clinical Markers of Change in Borderline Personality Disorder After Metacognitive Interpersonal Therapy - Standard Approach

Clinical trial NCT02370316 - References