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. Author manuscript; available in PMC: 2019 Oct 2.
Published in final edited form as: Am J Psychiatry. 2018 Apr 25;175(9):873–886. doi: 10.1176/appi.ajp.2018.17111282

TABLE 2.

Clinical Trials for Select combinatorial pharmacogenetic Decision Support Toolsa

ClinicalTrials.gov
Identifier		 Status Condition Study Type Study Design Comparators Enrollment Estimated
Completion
Date
GeneSight
NCT02109939b Recruiting Treatment-resistant major depression Interventional 12-week DB RCT, 24-week open-label follow-up GeneSight versus TAU 1,200 (estimated) March 2017
NCT02573168 Recruiting Schizophrenia,
schizoaffective
disorder		 Interventional 8-week 3-arm, parallel group, DB RCT, 12-month follow-up GeneSight versus enhanced GeneSight versus TAU 531 Dec. 2017
NCT02466477b Recruiting Treatment-resistant major depression Interventional 8-week 3-arm, parallel group, DB RCT, 12-month follow-up GeneSight versus enhanced GeneSight versus TAU 570 (estimated) June 2017
NCT02286440 Recruiting Depression
(adolescent)		 Interventional 8-week DB RCT, crossover assignment GeneSight versus TAU 276 (estimated) Jan. 2018
NCT02189057b Recruiting Major depression, bipolar I or II disorder, schizoaffective bipolar disorder Interventional 8-week DB RCT, crossover assignment GeneSight versus TAU 276 (estimated) June 2017
NCT02770339 Recruiting Pediatric psychiatric crisis Observational Prospective Gene-drug match versus mismatch TBD Dec. 2017
NCT01261364 Completed Major depression, depression NOS Interventional 8-week DB RCT GeneSight versus TAU 50 Jan. 2011
NCT01610063 Completed Major depression, depression NOS Interventional 8-week randomized open-label pilot GeneSight versus TAU 227 Nov. 2011
NCT02479464 Completed Major depression, depression NOS Interventional NRC open-label pilot GeneSight versus TAU 60 Sep. 2010
IDgenetix
NCT02878928 Completed Major depression, anxiety Interventional 12-week prospective multicenter DB RCT IDgenetix versus TAU 579 Dec. 2016
NCT02411123 Completed Depression, anxiety Interventional 4-month prospective randomized clinical study IDgenetix versus TAU 220 Dec. 2015
NCT02599870 Ongoing Acute pain surgery Interventional Prospective randomized clinical study IDgenetix versus TAU 56 July 2016
NCT02605343 Completed Acute pain surgery Observational Prospective observational clinical study IDgenetix versus TAU 110 April 2016
CNSDose
ACTRN126130 01135707 Completed Major depression Interventional 12-week prospective DB RCT CNSDose versus TAU 174 July 2013
GeneCept
NCT01507155 Completed Treatment-resistant depression, generalized anxiety disorder Observational 3-month prospective open-label nonrandomized Single group assignment 685 May 2014
NCT02634177b Recruiting Major depression Interventional 8-week prospective DB RCT GeneCept versus TAU 335 (estimated) May 2017
NCT01438242 Withdrawn
NCT01426516 Terminated
NCT02883660 Recruiting Depression adverse effects Observational Retrospective case-control study 100 Aug. 2018
NCT01555021 Terminated
NCT02566057 Recruiting Psychosis Interventional 12-month prospective SB RCT GeneCept versus TAU 100 June 2017
a

DB=double blind; NOS=not otherwise specified; NRC=nonrandomized control; RCT=randomized controlled trial; SB=single blind; TAU=treatment as usual; TBD=to be determined.

b

Active combinatorial pharmacogenetics-guided trials for major depression.