Design and Methodology for SIB Treatment Studies Sub-group

Design and Methodology for SIB Treatment Studies Bibliography

Working Group Goal:
Review current approaches and develop consensus on the key requirements for design of clinical studies and programs to be used for regulatory approval of therapies to treat SIB

Possible Activities:

–Compare design approaches: Independent, trans-nosological identification (ie, across primary psychiatric or medical   diagnoses) vs. linked to diagnosis (e.g. as a symptom of depression or anxiety)

–Review study design considerations for treatment trials and make recommendations

–Review acute and maintenance designs and make recommendations

–Review patient selection and make recommendations

–Review considerations around use of placebo and make recommendations

–Review outcome measures and make recommendations

–Review use of biomarkers

• Review of promising biomarkers for SIB
• Develop considerations and recommendation regarding inclusion in SIB treatment trials

–Review management of suicide risk in clinical trials and make recommendations

Sub-group Members:

Alan Brier, Indiana University
Heather Bryson, PPDI
Bob Buchanan, University of Maryland
Carla Canuso, Janssen
Jordan DeVylder, University of Maryland
Franco Di Cesare, Leoben Research
Ebrahim Haroon, Emory University
Yuko Hirata, INC Research
Sid Kennedy, University of Toronto
Andrew Krystal, Duke University
William Lenderking, Evidera
J.P. Lindenmayer, Nathan Kline Institute
Herbert Meltzer, Northwestern University
Andrew Nierenberg, Massachusetts General Hospital
Charles Nemeroff, University of Miami
Tina Oakes, Lilly
Anne-Marie Quinn, Janssen
David Sheehan, University of South Florida
Michelle Stewart, Pfizer
Eliseo Salinas, Turing Pharmaceuticals
David Walling, Collaborative Neuroscience Network

Design and Methodology for SIB Treatment Studies Internal Working Group Documents