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OBJECTIVES: The main aim of the study was to assess the incidence of metabolic syndrome and its individual components in patients subject to a confinement measure, treated with antipsychotics in mono - or polytherapy. Additional objectives included the analysis of associations between the occurrence of metabolic syndrome and patients' age, psychiatric diagnosis, overweight or obesity, and the presence of addictions to psychoactive substances. METHODS: The study involved 61 patients of the Department of Forensic Psychiatry, including 9 women and 52 men, subject to a confinement measure from September 2019 to August 2021. All parameters of metabolic syndrome and BMI were measured twice, at the beginning of the stay at the Department and after six months of treatment with atypical antipsychotics. Appropriate statistical comparative analyses were then performed. RESULTS: There was no relationship between the occurrence of metabolic syndrome and the age of the subjects, medical diagnosis, addiction to psychoactive substances, including smoking. It has not been confirmed that the chronic use of atypical antipsychotics with parallel prophylactic and health-promoting effects in conditions of confinement leads to the development of metabolic syndrome and worsens its symptoms, apart from a marked increase in waist circumference and an increase in BMI. CONCLUSIONS: Systematic measurements of BMI and waist circumference during treatment with atypical antipsychotics may be accurate tools in assessing the risk of metabolic syndrome. Long-term confinement hospitalizations should include psychoeducational nterventions aimed at minimizing metabolic complications of pharmacotherapy.
RESUMO
BACKGROUND: The aim of the study was to examine the efficacy and safety of morning bright light therapy (BLT) in the treatment of patients with a current major depressive episode (MDE) in bipolar and unipolar disorder without a seasonal pattern. It was a randomized, sham-controlled trial. METHODS: Adults, ages 18-70 years were randomized to treatment either with BLT or a sham negative ion generator (as a placebo control). The subjects were required to be on a stable and therapeutic dose of psychotropic medication for at least 4 weeks prior to enrollment and their treatment had to be insufficiently effective. Their clinical state was monitored at the baseline and at the end of treatment. The Hamilton Depression Rating Scale-21 items (HDRS-21), Montgomery-Asberg Depression Rating Scale (MADRS), Beck Depression Inventory (BDI-II), Clinical Global Impression-Severity (CGI-S) and Patient Global Impression (PGI) were used. The results were analyzed with an intention-to-treat (ITT) analysis. RESULTS: Ninety-five patients were enrolled (50 diagnosed with bipolar disorder and 45 with unipolar depression). Fifty-two patients were randomized to treatment with BLT and forty-three were in the placebo group (ITT population). Eighty-three subjects completed the study. There were 12 dropouts (5 in the light group and 7 in the placebo group). After 14 days of treatment, a significant improvement was found in all groups (p<0.001). The subjects treated with BLT did not significantly differ in terms of improvement in HDRS-21 scores at the endpoint when compared to patients treated with placebo (p=0.2). However, further analysis demonstrated significantly higher response (50% v. 27.9%, p=0.02) and remission rates (28.8% v. 11.6%, p=0.04) among patients treated with morning BLT when compared to placebo group. It should be noted that in the population of drug-resistant patients, BLT was more efficacious than placebo. There were no statistically significant differences between unipolar and bipolar disorders (p=0.4). CONCLUSION: Although overall improvement in HDRS-21 scores were not superior in the BLT group, both response and remission rates were significantly higher among patients treated with BLT relative to those receiving the sham intervention. BLT was also more efficacious than placebo in the population of patients with drug-resistant depression. Further studies to define the subpopulation of patients with non-seasonal depression who may benefit the most from BLT are needed.