This report describes the development of a new questionnaire designed to capture and quantify the psychosocial impact of weight gain associated with psychotropic drug use, and presents results of a preliminary validation study. Based on a review of literature, consultations with experts, interviews with individual patients and focus groups, themes relevant to weight gain and its psychosocial consequences were identified. A 12-item self-report questionnaire was designed and administered to a heterogeneous group of psychiatric outpatients (n = 141) receiving antipsychotic and other adjunctive medications. The scale could be self-administered in 2-3 min with minimal assistance. Correlational analysis showed a high internal consistency (Cronbach's alpha 0.79) and fair split half reliability (Spearman-Brown coefficient of 0.76). The total scores were able to distinguish groups of people with higher and lower body mass index (BMI) (chi(2) = 16.4, P < 0.001), suggestive of good discriminant validity. Repeated administration of the scale in 56 subjects on 2 occasions with a gap of 1 week in between revealed a test-retest reliability coefficient of 0.81 (p < 0.001). These preliminary findings indicate that body weight, image and self-esteem evaluation questionnaire (B-WISE) is a potentially useful instrument for clinical trials to measure the psycbosocial consequences of weight changes associated with psychotropic drug use, and also in monitoring the impact of various intervention programs aimed at minimizing or preventing weight gain. (C) 2004 Elsevier B.V. All rights reserved.