Multigenetic Pharmacogenomics–Guided Treatment vs Treatment As Usual Among Hospitalized Men With Schizophrenia

Author:

Kang Zhewei123,Qin Ying4,Sun Yutao5,Lu Zhe123,Sun Yaoyao123,Chen Huan6,Feng Xiaoyang123,Zhang Yuyanan123,Guo Hua7,Yan Hao123,Yue Weihua12389

Affiliation:

1. Institute of Mental Health, Peking University Sixth Hospital, Beijing, China

2. National Clinical Research Center for Mental Disorders, Peking University Sixth Hospital, Beijing, China

3. NHC Key Laboratory of Mental Health, Research Unit of Diagnosis and Treatment of Mood Cognitive Disorder, Chinese Academy of Medical Sciences, Beijing, China

4. The Second People’s Hospital of Guizhou Province, Guiyang, China

5. Tangshan Mental Health Center, Tangshan Fifth Hospital, Tangshan, China

6. Shantou University Mental Health Center, Shantou, China

7. Zhumadian Second People’s Hospital, Zhumadian, China

8. PKU-IDG/McGovern Institute for Brain Research, Peking University, Beijing, China

9. Chinese Institute for Brain Research, Beijing, China

Abstract

ImportanceLimited evidence supports multigenetic pharmacogenomics–guided treatment (MPGT) in schizophrenia.ObjectiveTo evaluate the clinical effectiveness of MPGT in schizophrenia in a randomized clinical trial (RCT).Design, Setting, and ParticipantsThis RCT was conducted from March 2020 to March 2022. Male Chinese Han inpatients aged 18 to 60 years diagnosed with schizophrenia with a Positive and Negative Symptom Scale (PANSS) score of 60 or more from 2 selected study hospitals were included. Patients and raters were masked to MPGT or treatment as usual (TAU) randomization.InterventionsParticipants were randomly assigned in a 1:1 ratio to receive either MPGT or TAU for 12 weeks.Main Outcomes and MeasuresThe primary efficacy outcome was the percentage change in PANSS total scores (range, 30 to 210) from baseline to week 6 analyzed by a modified intention-to-treat mixed model for repeated measures. The secondary outcome included response and symptomatic remission rates.ResultsA total of 210 participants (mean [SD] age, 29.2 [8.8] years) were enrolled and analyzed, with 113 assigned to MPGT and 97 to TAU. Compared with those randomized to TAU, participants randomized to MPGT demonstrated a significantly higher percentage change in PANSS score (74.2% vs 64.9%; adjusted mean difference, 9.2 percentage points; 95% CI, 4.4-14.1 percentage points; P < .001) and a higher response rate (93 of 113 [82.3%] vs 63 of 97 [64.9%]; adjusted odds ratio, 2.48; 95% CI, 1.28-4.80; P = .01) at the end of week 6.Conclusions and RelevanceIn this RCT of MPGT, MPGT was more effective than TAU in treating patients with schizophrenia. These findings suggest that multigenetic pharmacogenomic testing could serve as an effective tool to guide the treatment of schizophrenia.Trial RegistrationChinese Clinical Trial Registry Identifier: ChiCTR2000029671

Publisher

American Medical Association (AMA)

Subject

General Medicine

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