Evidence map›Paper›PMID 37403159›Full record

Trial reportJournal of translational medicine2023

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

Xiaoe Lang, Mei Xue, Xiaocui Zang, Fengchun Wu, Meihong Xiu, Xiangyang Zhang

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of translational medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04076371 (The Treatment Efficacy of Combination Atypical Antipsychotics With Sertraline in Patients With Schizophrenia), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.6field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04076371 nacompletednot on this map

The Treatment Efficacy of Combination Atypical Antipsychotics With Sertraline in Patients With Schizophrenia

TypeinterventionalSponsorBeijing HuiLongGuan HospitalRan2012 to 2018Enrolled1,640ConditionsSchizophreniaArmsolanzapine-sertraline combination, only olanzapine, risperidone-sertraline combination, only risperidone, paliperidone-sertraline combination
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 7 citations in OpenAlex.

  1. Efficacy of sertraline combined with low-dose antipsychotics in first-episode schizophrenia.European archives of psychiatry and clinical neuroscience · 2026
    Article
  2. Antidepressant Augmentation of Antipsychotic Treatment in Schizophrenia: A Narrative Review.Medical science monitor : international medical journal of experimental and clinical research · 2026
    Review
  3. Review
  4. Article
  5. The antipsychotic potential ofIBRO neuroscience reports · 2024
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 5 institutions in 2 countries.

Xiaoe LangDepartment of Psychiatry, First Hospital of Shanxi Medical University, Taiyuan, China.
Mei XueQingdao Mental Health Center, Qingdao, China.
Xiaocui ZangQingdao Mental Health Center, Qingdao, China.
Fengchun WuDepartment of Psychiatry, The Affiliated Brain Hospital of Guangzhou Medical University, Guangzhou, China. 13580380071@163.com.
Meihong XiuPeking University HuiLongGuan Clinical Medical School, Beijing HuiLongGuan Hospital, Beijing, China. xiumeihong97@163.com.
Xiangyang ZhangCAS Key Laboratory of Mental Health, Institute of Psychology, Beijing, China. zhangxy@psych.ac.cn.
Qingdao Mental Health Center · CNBeijing HuiLongGuan Hospital · CNCenter for Translational Molecular Medicine · NLFirst Hospital of Shanxi Medical University · CNInstitute of Psychology, Chinese Academy of Sciences · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveDespite 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.

methodsA 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.

resultsRepeated 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.

conclusionsOur 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.

Indexed as

Antipsychotic AgentsDrug-Related Side Effects and Adverse ReactionsSchizophreniaHumansProlactinRisperidoneSertralineTreatment OutcomeAntipsychotic AgentsProlactinRisperidoneSertralineEfficacyFirst-episodeRisperidoneSchizophreniaSertraline

Identifiers

PMID37403159
PMCPMC10318661
OpenAlexW4383104541

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.