There is also laboratory monitoring of fasting plasma glucose, lipid levels, insulin, leptin, prolactin, and antipsychotic and/or mood stabilizer levels at baseline and at weeks 4, 8 and 12. Patients are followed monthly for the first three months, as well as every three months thereafter if continued on the atypical antipsychotic.
Correll told PT that 193 youngsters have completed the acute phase of the study. In the extension phase, 79 youngsters have completed six months; 50 have completed nine months; 52 have completed 12 months; and a few have been followed longer.
"We are building up the number of patients followed for one year and longer to be able to assess long-term effects on weight, metabolic indices and the incidence of neuromotor side effects, including tardive dyskinesia," Correll said.
The study will continue until at least 300 antipsychotic-naive youngsters are enrolled, in order to allow for a meaningful analysis of genetic influences on weight gain and metabolic indices, including blood sugar, insulin resistance and lipid abnormalities.
"However, interim results will soon be analyzed and submitted regarding the frequency and clinical predictors of weight gain and abnormal glucose and lipid metabolism; hyperprolactinemia and related sexual side effects; as well as predictors for medication persistence and non-adherence," Correll said.
A subgroup of the patients taking atypical antipsychotics also is being studied to elucidate the molecular mechanisms of antipsychotic-induced weight gain, he added. "We are doing weekly assessments of neuropeptides and cytokines during the first month."
The investigators hope the results from this substudy will help to identify patients who are at particular risk for weight gain and associated metabolic problems, in addition to the genetic predictors.
"Moreover, mechanistic insights could potentially provide novel treatment targets for the amelioration or even prevention of weight gain associated with antipsychotic treatment," Correll said. "If the mechanisms are similar to those of non-medication-associated weight gain/obesity, this could even help to ameliorate the pandemic of obesity in general. However, this is still only a theoretical argument."