ConLiGen member sites agree to contribute their samples to joint genetic projects within the limits of each site's IRB regulation. A large-scale candidate gene study of lithium response shall be the first joint genetic project. Funding permitting, a genome-wide association study will be performed.
Variables describing treatment tolerability or side effects may be studied in subsequent projects. Because the issue of 'best response phenotype' is far from trivial, ConLiGen will strive to continuously weigh evidence from future clinical and biological studies of lithium in an effort to refine the definition of phenotype response. Evaluating response to long-term treatment in an illness with a highly variable natural course presents a challenge. Many patients with bipolar disorder experience spontaneous remissions of variable timing and duration. Moreover, in a pharmacogenetic study we need to evaluate the quality of response not for groups of subjects as in clinical trials but individually for each patient. While prospective studies will be able to implement more precise measures, our approach is a practical way to assess the quality of response in a variety of patients treated in diverse settings.