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. 2023 Dec 4:14:1321233.
doi: 10.3389/fpsyt.2023.1321233. eCollection 2023.

Brexpiprazole in patients with schizophrenia with or without substance use disorder: an observational study

Ginevra Lombardozzi  1 , Giada Trovini  1 , Emanuela Amici  1 , Georgios D Kotzalidis  1   2   3   4 , Filippo Perrini  5 , Valeria Giovanetti  1 , Alessandro Di Giovanni  1 , Sergio De Filippis  1
Affiliations

Brexpiprazole in patients with schizophrenia with or without substance use disorder: an observational study

Ginevra Lombardozzi et al. Front Psychiatry. .

Abstract

Background: Partial dopamine D2 receptor agonists are used for psychotic symptoms in adults with schizophrenia spectrum disorders. Recently, interest surged for partial dopamine D2 receptor agonists in substance use disorders (SUDs). Since it is believed that SUDs decrease the efficacy of pharmacotherapy of underlying psychiatric disorders, we tested the efficacy of the partial D2 agonist brexpiprazole in patients with schizophrenia who were either comorbid with a SUD (SUD group) or not comorbid (non-SUD) to assess treatment response and the effect of brexpiprazole on substance craving in SUD.

Methods: We included patients with DSM-5/DSM-5-TR schizophrenia (using SCID-5-CV) aged 18-66 years with either comorbid SUD or non-SUD to treat with brexpiprazole 4 mg/day for 6 months during February-October 2022. Patients were assessed with the Clinical Global Impressions-Severity (CGI-S) scale, the 24-item Brief Psychiatric Rating Scale (BPRS), and the Positive And Negative Syndrome Scale (PANSS) at baseline, weekly for the first 2 months and monthly for the next four. Furthermore, we assessed substance craving in SUD with a visual analog scale for craving (VAScrav) at the same timepoints.

Results: The total sample was 86 (85 analysable) 18- to 64-year-old (mean 39.32 ± 14.09) patients with schizophrenia [51 men (59.3%) and 35 women (40.7%)], of whom 48 SUD (55.8%) (37 men and 11 women) and 38 non-SUD (44.2%) (14 men and 24 women). No serious or persistent adverse events developed over the study period, but one patient dropped out for subjective akathisia. Results indicated the main effects of time with improvements over the course of the study for CGI-S, BPRS, and PANSS in both SUD and non-SUD groups and the entire sample, and for VAScrav in SUD. Brexpiprazole was associated with similar significant improvements in both groups at the 6 month endpoint compared to baseline.

Conclusion: Treatment with brexpiprazole for 6 months improved psychotic symptoms in patients with schizophrenia, independently from whether they belonged to the SUD or the non-SUD group; hence, SUD comorbidity did not confer treatment resistance to brexpiprazole. Furthermore, in the SUD group, we observed reduced substance craving.

Keywords: antipsychotic medications; brexpiprazole; partial dopamine D2 receptor agonists; schizophrenia; substance use disorder.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Drop of Clinical Global Impressions (CGI-S) scores during the study in the groups with comorbid substance use disorder (SUD) and the non-comorbid group (non-SUD). The two groups look quite similar in their scores on this scale.
Figure 2
Figure 2
Course of the scores on the 24-item Brief Psychiatric Rating Scale-Expanded version (BPRS-24) in the groups with comorbid substance use disorder (SUD) and in the non-comorbid group (non-SUD). Both groups obtained about a 50% reduction from baseline to endpoint, but the non-SUD group scored constantly lower throughout the study, indicating that its participants fared better than the comorbid SUD group.
Figure 3
Figure 3
Course of the total scores of the Positive And Negative Syndrome Scale (PANSS) in the groups with comorbid substance use disorder (SUD) and the non-comorbid group (non-SUD). Both groups obtained >50% reduction from baseline to endpoint, compatible with clinical response, but similarly to what occurred with the BPRS-24, the non-SUD group scored constantly lower throughout the study, indicating that the non-comorbid group was clinically better than the comorbid SUD group.
Figure 4
Figure 4
Course of the scores on the Visual Analog Scale for craving (VAScrav) in the SUD comorbid group. This scale is rated by the patient from 0 to 10; at baseline, it was 7.47 and by the 6 month endpoint had dropped to 1.49, i.e., by >80%.
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Grants and funding

The author(s) declare financial support was received for the research, authorship, and/or publication of this article. This research has been supported by Otsuka Pharmaceutical Italy and, as its copromotion partner, by Lundbeck Italy. Both Companies were not involved in study conduction, data analyses, and manuscript publication.

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