The Evaluation of Atypical Antipsychotic Augmentation with Atomoxetine in the Reduction of Negative Symptoms in Patients with Schizophrenia: A Randomized, DoubleBlind, Placebo-Controlled Clinical TrialAuthor(s): Maryam Pourshams, Forough Riahi, Ashraf Tashakori and Fatemeh Erfanifar*
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.