Investigating the safety and efficacy of naltrexone for anti-psychotic induced weight gain in severe mental illness: study protocol of a double-blind, randomized, placebo-controlled trial

Table 1 Study flow

MINI, PANSS, Demographics, Physical Exam	Week 0
Urine toxicology, pregnancy test for female subjects, fluorescence check in urine for compliance	Week 0 and every 4 weeks subsequently + as needed determined by study physician
Fasting Glucose, Insulin, HbA1c, Lipid Profile, Liver function tests, FTND	Week 0, 16, 32, 52
Serum leptin, ghrelin, peptite YY, adiponectin, high sensitivity CRP, TNF-α, IL-1B, IL-6, IL-18	Week 0, 16, 52
Framingham Score	Calculated same time with blood draws.
Vitals (Blood Pressure, pulse)	Weekly for first 4 weeks, then every two weeks
Weight, BMI	Weekly for first 4 weeks, then every two weeks
Waist Circumference, 24hr Food Recall, BPRS, BDI, CDSS, C-SSRS, QCSRF, QLS-Q-18, SF-36, RMR, TFEQ, YPAS	Week 0 and every 4 weeks
UKU side effects	Weekly for first 4 weeks, then every two weeks
Cognitive Battery (BACS)	Week 0, Week 16, Week 52

Abbreviations: BACS The Brief Assessment of Cognition in Schizophrenia, BDI Beck Depression Inventory, BMI Body Mass Index, BPRS Brief Psychiatric Rating Scale, CDSS Calgary Depression Scale for Schizophrenia, C-SSRS Calgary Depression Scale for Schizophrenia, FTND The Fagerström Test for Nicotine Dependence, MINI The Mini-International Neuropsychiatric Interview, PANSS Positive and Negative Syndrome Scale, QCSRF The Questionnaire on Craving for Sweet or Rich Foods, QLS-Q-18 Quality of Life Enjoyment and Satisfaction Questionnaire, RMR: Resting Metabolic Rate, SF-36 SF-36 Health Related Quality of Life Questionnaire, TFEQ Three Factor Eating Questionnaire, YPAS The Yale Physical Activity Survey.

ISSN: 1471-244X