The assessment of quality of life (QoL) and economic outcomes of psychotropic medications are closely related. Both costs and QoL are important in establishing the value of new and existing drugs in order to assist patients, physicians, payors of health care, and society to make optimal decisions. These parameters may be combined, as in cost-utility analyses, or analysed separately. Although not a true reflection of normal practice, clinical trials are most often the setting for measurement of these parameters. The viability of such analyses, which often necessitate the inclusion of active comparators and additional work measuring costs and QoL, within the context of controlled studies must be established early on in the development process. If ‘registration oriented’ trials are inappropriate, alternative strategies must be pursued.