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Objective <p>Many individuals suffering from schizophrenia discontinued antipsychotic drugs, frequently due to dose-related multiple and severe adverse effects, especially in first-episode patients. We hypothesized that a low-dose paliperidone in combination with sertraline, an SSRI that increases cortical dopamine and serotonin, would reduce serious side effects without affecting treatment efficacy. Therefore, this study was designed to investigate whether low-dose paliperidone plus sertraline would improve negative symptoms and psychosocial functioning without affecting the antipsychotic efficacy of positive symptoms in medication-naive and first-episode (MNFE) patients with schizophrenia to minimize the influence of potential confounding factors, including prior antipsychotic drugs and disease duration.</p> Methods <p>This is a 24-week, open-label, randomized controlled trial. In this study, we randomly assigned 188 MNFE schizophrenia patients to receive either a half dose of paliperidone in combination with sertraline (PS group, n = 94) or a usual dose of paliperidone monotherapy (Control group, n = 94). Primary outcome measures included negative symptoms and psychosocial functioning as assessed by the Personal and&#xa0;Social&#xa0;Performance Scale (PSP). Secondary outcome measures included psychotic symptoms as assessed by the Positive and Negative Syndrome Scale (PANSS) and depressive symptoms as evaluated by the Hamilton Depression Rating Scale (HAMD).</p> Results <p>We found that treatment with paliperidone plus sertraline was correlated with greater improvements from baseline to week 24 in negative symptoms and psychosocial functioning compared to paliperidone monotherapy [mean reductions in negative symptoms: 11.7 [95% confidence&#xa0;interval&#xa0;(CI):11.2 to 12.2] vs. 14.6 (95% CI:14.1 to 15.0), F = 69.8, <i>p</i> &lt; 0.001; mean increases in psychosocial functioning: 43.7 (95% CI:42.8 to 44.6) vs. 53.9 (95% CI:52.9 to 54.8), F = 237.2, <i>p</i> &lt; 0.001]. In addition, improvements in psychosocial functioning were associated with a reduction in negative symptoms in patients (β = − 0.48, t = − 2.8, <i>p</i> = 0.007). The combination treatment was also relatively superior to monotherapy in terms of depressive symptoms (F = 37.0, <i>p</i> &lt; 0.001) and comparable in terms of psychotic symptoms (<i>p</i> &gt; 0.05).</p> Conclusions <p>This open-label study demonstrates that half of the usual dose of paliperidone plus sertraline is efficacious in the treatment of MNFE patients with schizophrenia with respect to their negative symptoms and psychosocial functioning. However, the limitations included the open-label design, absence of a placebo arm, and short 12-week follow-up. Further, longer-term, double-blind trials are warranted to confirm our findings. If confirmed, this combination could offer a practical, low-risk strategy to close the persistent efficacy gap for negative and cognitive symptoms in schizophrenia.</p>

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Low-dose paliperidone combined with sertraline for first-episode and medication-naïve patients with schizophrenia: an open-label, randomized trial

  • 期刊论文

  • 发表日期：

    2025年11月22日

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  • Zhonghui Lin,
  • Xiaoni Guan,
  • Xiaoe Lang,
  • Meihong Xiu,
  • Fengchun Wu

摘要

Objective

Many individuals suffering from schizophrenia discontinued antipsychotic drugs, frequently due to dose-related multiple and severe adverse effects, especially in first-episode patients. We hypothesized that a low-dose paliperidone in combination with sertraline, an SSRI that increases cortical dopamine and serotonin, would reduce serious side effects without affecting treatment efficacy. Therefore, this study was designed to investigate whether low-dose paliperidone plus sertraline would improve negative symptoms and psychosocial functioning without affecting the antipsychotic efficacy of positive symptoms in medication-naive and first-episode (MNFE) patients with schizophrenia to minimize the influence of potential confounding factors, including prior antipsychotic drugs and disease duration.

Methods

This is a 24-week, open-label, randomized controlled trial. In this study, we randomly assigned 188 MNFE schizophrenia patients to receive either a half dose of paliperidone in combination with sertraline (PS group, n = 94) or a usual dose of paliperidone monotherapy (Control group, n = 94). Primary outcome measures included negative symptoms and psychosocial functioning as assessed by the Personal and Social Performance Scale (PSP). Secondary outcome measures included psychotic symptoms as assessed by the Positive and Negative Syndrome Scale (PANSS) and depressive symptoms as evaluated by the Hamilton Depression Rating Scale (HAMD).

Results

We found that treatment with paliperidone plus sertraline was correlated with greater improvements from baseline to week 24 in negative symptoms and psychosocial functioning compared to paliperidone monotherapy [mean reductions in negative symptoms: 11.7 [95% confidence interval (CI):11.2 to 12.2] vs. 14.6 (95% CI:14.1 to 15.0), F = 69.8, p < 0.001; mean increases in psychosocial functioning: 43.7 (95% CI:42.8 to 44.6) vs. 53.9 (95% CI:52.9 to 54.8), F = 237.2, p < 0.001]. In addition, improvements in psychosocial functioning were associated with a reduction in negative symptoms in patients (β = − 0.48, t = − 2.8, p = 0.007). The combination treatment was also relatively superior to monotherapy in terms of depressive symptoms (F = 37.0, p < 0.001) and comparable in terms of psychotic symptoms (p > 0.05).

Conclusions

This open-label study demonstrates that half of the usual dose of paliperidone plus sertraline is efficacious in the treatment of MNFE patients with schizophrenia with respect to their negative symptoms and psychosocial functioning. However, the limitations included the open-label design, absence of a placebo arm, and short 12-week follow-up. Further, longer-term, double-blind trials are warranted to confirm our findings. If confirmed, this combination could offer a practical, low-risk strategy to close the persistent efficacy gap for negative and cognitive symptoms in schizophrenia.