Efficacy of low-dose risperidone in combination with sertraline in first-episode drug-naïve patients with schizophrenia: a randomized controlled open-label study.

OBJECTIVE: Despite advances in pharmacology, the treatment of schizophrenia (SZ) remains a challenge due to relapse after antipsychotic discontinuation and multiple adverse effects of antipsychotics. We hypothesized that a low dose of risperidone in combination with sertraline would reduce serious adverse effects without decreasing treatment response. This study aimed to examine the efficacy, safety, and tolerability of low-dose risperidone combined with sertraline to reduce risperidone dose and serious adverse effects in first-episode and medication-naive (FEMN) SZ patients. METHODS: A total of 230 patients with FEMN SZ were randomly assigned to receive low-dose risperidone in combination with sertraline (RS group) or regular-dose risperidone (control group). The Positive and Negative Syndrome Scale (PANSS), Hamilton Depression Rating Scale (HAMD), and Personal and Social Performance Scale (PSP) were assessed at baseline and the end of the first, second, third, and sixth months. In addition, serum prolactin levels and extrapyramidal symptoms were measured at baseline and follow-up. RESULTS: Repeated measures ANCOVA showed significant interaction effects of treatment by time on psychotic symptoms, as well as HAMD, PSP scores, prolactin levels, and extrapyramidal symptoms (all p < 0.05). Compared with the control group, the RS group had greater decreases in PANSS total score and its subscores and HAMD score (all p < 0.01) and a greater increase in PSP total score (p < 0.01). Notably, side effects were lower in the RS group relative to the control group. Improvements in HAMD and PANSS total scores, changes in prolactin levels and gender predicted improvements in PSP from baseline to month 6. CONCLUSIONS: Our study suggests that low-dose risperidone in combination with sertraline was more effective for psychotic symptoms and psychosocial functioning, with significantly fewer adverse effects in patients with FEMN SZ. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT04076371.

Effects of low-dose combined olanzapine and sertraline on negative and depressive symptoms in treatment-resistant outpatients with acute exacerbated schizophrenia.

Background: Treatment-resistant schizophrenia (TRS) is a major clinical challenge. Current antipsychotic medications do not adequately address negative and depressive symptoms in patients with TRS, and novel treatments are thus needed. This study examines the efficacy of low-dose combined olanzapine (OLA) and sertraline on depressive and negative symptoms in patients with TRS. Methods: A total of 34 TRS outpatients with acutely exacerbated schizophrenia were randomly assigned to OLA monotherapy (12.5-20 mg/day) (control group) or low-dose combined OLA (7.5-10 mg/day) and sertraline (50-100 mg/day) (OS group). Clinical symptoms were assessed using the Positive and Negative Syndrome Scale (PANSS) at baseline and at the end of treatment in weeks 4, 8, 12, and 24. Depressive symptoms and social functioning were also assessed. Results: Compared to the control group, the OS group showed significant improvements in depressive and negative symptoms over time. In addition, the low-dose combination of OLA and sertraline significantly improved social functioning compared with OLA monotherapy. There were no significant between-group differences in psychotic symptom improvement. However, the reduction in Hamilton Depression Rating Scale total score and PANSS negative subscore were not associated with improvements in social functioning, suggesting that these effects of combined treatment are independent. Conclusion: Low-dose combined OLA and sertraline may be effective in the treatment of negative and depressive symptoms compared with standard OLA monotherapy in patients with TRS who are experiencing an acute exacerbation of schizophrenia. Clinical Trial Registration: [ClinicalTrials.gov], identifier [NCT04076371].

The relationship between overweight and thyroid function in first-episode, untreated Chinese patients with major depressive disorder with different ages of onset.

BACKGROUND: Major depressive disorder (MDD) and obesity are common. There are many differences in many aspects of MDD patients at different ages of onset (AOO); however, there are currently no studies on differences in obesity or overweight. This study aims to evaluate whether thyroid function changes with body weight, and to explore the related factors of overweight in MDD patients with different AOOs. METHODS: A total of 1716 first-episode, untreated Chinese Han outpatients with MDD were recruited from a general hospital. Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale (HAMD) and Positive Symptom subscale of the Positive and Negative Syndrome Scale (PANSS) were used to evaluate anxiety, depression and psychotic symptoms, respectively. The participants were divided into two groups: early adulthood onset (EAO, <45 years old) and mid-adulthood onset (MAO, >=45 years old). RESULTS: Compared with EAO patients, MAO patients scored higher on the HAMD, HAMA, CGI-S and PANSS positive symptoms subscale, and they also had higher systolic and diastolic blood pressure (BP), higher serum levels of thyroid stimulating hormone (TSH), FBG, cholesterol (TC) and low-density lipoprotein, but they had lower serum levels of free triiodothyronine 3 and high-density lipoprotein. TSH, anti-thyroglobulin (TgAb), TC and systolic BP were correlated with overweight in MAO patients, while TSH and FBG were correlated with overweight of EAO patients. CONCLUSIONS: The results indicate that TSH is related to overweight in both AOO subgroups, and the influencing factors of overweight related to thyroid function may be different in different AOOs.