Utility of the daily prospective National Institute of Mental Health Life-Chart Method (NIMH-LCM-p) ratings in clinical trials of bipolar disorder.

This study investigated the assets of the daily prospective National Institute of Mental Health Life-Chart Method (NIMH-LCM-p or LCM-p) for use in clinical trials in bipolar disorder. Fifty-two outpatients, who met DSM-III-R criteria for bipolar disorder, were randomly assigned in a double-blind design to an intended 1 year of treatment with lithium or carbamazepine, a crossover to the opposite drug in the second year, and then to a combination of both agents in the third year. For each patient, the LCM-p was initiated upon admission and was continued on a daily basis. Overall therapeutic effect for each phase (intended year) was assessed by using the Clinical Global Impressions-Bipolar Version (CGI-BP) scale. Kruskal-Wallis analysis of variance was used to examine the detailed course-of-illness variables derived from the LCM-p (e.g., percentage of time ill, average severity of illness, episodes per year, and mood switches per year) in relation to the global assessments of treatment response (CGI-BP). Most of the individual LCM-p-derived illness variables varied significantly (P <.05) as a function of global treatment response. Since global ratings of the degree of improvement can represent very different proportions of improvement in percentage of time ill, average severity of mania or depression, or frequency of manic and depressive episodes, the LCM-p provides the basis for a comprehensive description of both the illness course and the response to treatment. The LCM-p appears to have considerable utility in clinical trials of pharmacological and other interventions of bipolar disorder. It provides a detailed characterization of the severity, frequency, and duration of manic and depressive episodes, which facilitates the assessment of global improvement and allows for the quantification of separate components of the illness, which are or are not responsive to a given treatment. Copyright 2002 Wiley-Liss, Inc.

RCT Entities:   Population Interventions Outcomes