Hybrid Open Access Research Article Clinical Schizophrenia & Related Psychoses Clin Schizophr Relat Psychoses Volume 14:2, 2020 The Evaluation of Atypical Antipsychotic Augmentation with Atomoxetine in the Reduction of Negative Symptoms in Patients with Schizophrenia: A Randomized, Double- Blind, Placebo-Controlled Clinical Trial Abstract Background and purpose: Schizophrenia is one of the most severe psychiatric disorders with a chronic and debilitating condition. Negative symptoms are common in patients with schizophrenia that have not yet responded well to drugs. The aim of this study is to evaluate the effect of adding Atomoxetine to atypical antipsychotics in reducing the negative symptoms in schizophrenic patients. Materials and methods: In this randomized, double-blind, placebo-controlled clinical trial during 2018-2020, 60 DSM-V based schizophrenic patients were enrolled to the study. They were divided into case (n=30) and control (n=30) groups. Case group received Atomoxetine, 40 mg daily in the first week and 40 mg daily in the following weeks and the control group received placebo. The effect of medication on negative symptoms in both groups was compared by PANSS scale at baseline and weeks 4 and 8. The data analyzed by using SPSS software version 22. Result: The mean age of the patients was 30.00 ± 8.50 years and the majority of patients were male (55%). There was no statistically significant difference between the negative symptoms of case and control group at the beginning of the study (19.86 ± 3.00 vs. 20.83 ± 3.51 p=0.257) and in the fourth week (16.53 ± 2.56 vs. 17.46 ± 3.00 p=0.201). But in the eighth week, general (26.90 ± 5.33 vs. 31.50 ± 7.41 p=0.008), negative (11.83 ± 1.87 vs. 15.83 ± 2.98 p=0.001), and Total symptoms (52.16 ± 8.33 vs. 62.33 ± 9.37 p=0.002) were significantly lower in the case group than in the control group. Conclusion: This study showed that Atomoxetine significantly reduces the negative, general and total PANSS score in schizophrenic patients. This can improve treatment and quality of life in these patients. Therefore, the findings of this study confirmed the addition of Atomoxetine to the treatment of schizophrenia to improve treatment of negative symptoms. Keywords: Schizophrenia • Atomoxetine hydrochloride • Antipsychotic agents • Quality of life Maryam Pourshams 1 , Forough Riahi 1 , Ashraf Tashakori 1 and Fatemeh Erfanifar 2* 1 Department of Child and Adolescent Psychiatry, Department of Psychiatry, Golestan Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran 2 Student Research Committee, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran *Corresponding Author: Dr. Fatemeh Erfanifar, Student Research Committee, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran, Tel: +09192961401; E-mail: vakili.f63@gmail.com Copyright: © 2020 Pourshams M, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Received 09 October, 2020; Accepted 23 October, 2020; Published 30 October, 2020 Introduction Today, psychiatric disorders as one of the major problems in global health have become more and more important for researchers, and efforts to better manage the treatment of patients and find new pharmacological and non-pharmacological methods have become particularly important [1-3]. One of the most common psychiatric disorders is schizophrenia. Schizophrenia is one of the most severe psychiatric disorders with a chronic and debilitating condition [4,5]. The main manifestations of the disease include positive and negative symptoms [6,7]. Positive symptoms include hallucinations, delusions, confused behaviors, and confusion [8,9]. Negative symptoms include a lack of willpower, inability to initiate and purposeful activities, a lack of understanding and enjoyment of activities, and an emotional slowdown as well as a decrease in verbal communication and word production. Negative symptoms are the most important symptoms of schizophrenia [10,11]. Generally, according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria, the diagnosis of schizophrenia requires at least two symptoms: delusions, hallucinations, Disorganized speech, Grossly disorganized or catatonic behavior, and negative symptoms for a period of one month. In addition, symptoms should be on the threshold or stay for at least 6 months and should be accompanied by a significant decrease in social or occupational performance. Symptoms should not be due to medical conditions or medication use [12,13]. Negative symptoms in schizophrenia are less known than positive symptoms, but it can be claimed that negative symptoms are the most important symptoms in schizophrenia because they represent the best predictor of future schizophrenia disability [14]. Negative symptoms associated with demographic characteristics such as male gender, pre-existing academic and occupational performance, early onset of illness, and longer duration of related illness [15]. Negative symptoms can be considered a major deficiency in the underlying systems involved in interpersonal relationships by a patient with schizophrenia. Treatment strategy for this patient include atypical antipsychotic and typical antipsychotic drugs. Atypical antipsychotic drugs that are newer have fewer motor side effects than typical antipsychotic drugs. But in spite of this superiority in treating the negative symptoms of the disease, only a slight superiority has been achieved [16-18]. No effective treatment has been known to treat the negative symptoms of the disease, which are the most harmful symptoms of schizophrenia. Progressive damage to the noradrenergic pathway has been shown to cause negative symptoms of schizophrenia [19]. Recently, booster therapy with norepinephrine reuptake inhibitors has been proven to be a treatment for schizophrenia [20]. Studies of the efficacy of Atomoxetine in the treatment of schizophrenia have shown that Atomoxetine has little benefit in improving cognitive symptoms [21]. DOI: 10.3371/CSRP.PMRF.101920