Safety and Efficacy of High-Dose Vitamin B6 as an Adjunctive Treatment for Antipsychotic-Induced Hyperprolactinemia in Male Patients With Treatment-Resistant Schizophrenia
This study aimed to investigate the safety and efficacy of high-dose vitamin B6 (vB6) as an adjunct treatment for antipsychotic-induced hyperprolactinemia (AIHP) in male patients with treatment-resistant schizophrenia (TRS). In this randomized double-blinded controlled study, patients were randomize...
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Frontiers Media S.A.
2021-08-01
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| Series: | Frontiers in Psychiatry |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fpsyt.2021.681418/full |
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| author | Chuanjun Zhuo Chuanjun Zhuo Yong Xu Yong Xu Haibo Wang Tao Fang Tao Fang Jiayue Chen Jiayue Chen Chunhua Zhou Qianchen Li Jie Liu Shuli Xu Cong Yao Weiliang Yang Anqu Yang Bo Li Yuhui Chen Hongjun Tian Hongjun Tian Chongguang Lin |
| author_facet | Chuanjun Zhuo Chuanjun Zhuo Yong Xu Yong Xu Haibo Wang Tao Fang Tao Fang Jiayue Chen Jiayue Chen Chunhua Zhou Qianchen Li Jie Liu Shuli Xu Cong Yao Weiliang Yang Anqu Yang Bo Li Yuhui Chen Hongjun Tian Hongjun Tian Chongguang Lin |
| author_sort | Chuanjun Zhuo |
| collection | DOAJ |
| description | This study aimed to investigate the safety and efficacy of high-dose vitamin B6 (vB6) as an adjunct treatment for antipsychotic-induced hyperprolactinemia (AIHP) in male patients with treatment-resistant schizophrenia (TRS). In this randomized double-blinded controlled study, patients were randomized (1:1) into a control group given aripiprazole (ARI; 10 mg/day; n = 100) or an intervention group given vB6 (300 mg/12 h for 16 weeks; n = 100). Prolactin levels, psychotic symptoms [Positive and Negative Syndrome Scale (PANSS)], cognitive function [MATRICS Consensus Cognitive Battery (MCCB)], liver function, kidney function, growth hormone level, micronutrient levels, blood lipids, and adverse secondary effects (ASEs)[Treatment Emergent Symptom Scale (TESS) and Barnes-Akathisia scale] were monitored. After a 16-week treatment period, the vB6 group showed a 68.1% reduction in serum prolactin levels (from 95.52 ± 6.30 μg/L to 30.43 ± 18.65 μg/L) while the ARI group showed only a 37.4% reduction (from 89.07 ± 3.59 μg/L to 55.78 ± 7.39 μg/L). During weeks 1–4, both treatments reduced prolactin similarly. Subsequently, the ARI effect plateaued, while the vB6 effect remained robust. The vB6 group showed better alleviation of psychotic symptoms and cognitive impairment. No serious ASEs were observed; ASEs were more frequent in the ARI group. AIHP reduction efficacy of vB6 was associated with baseline prolactin and triglyceride levels, total vB6 dosage, and education level. In conclusion, compared with the ARI group, TRS patients given vB6 showed better attenuation of AIHP, lower ASE scores, and greater improvements in clinical symptoms and cognitive impairments. These results support further consideration of vB6 as a putative treatment for AIHP.Trial Registration: ChiCTR1800014755 |
| first_indexed | 2024-12-21T22:26:26Z |
| format | Article |
| id | doaj.art-d882f314649747878dd7833db1ad8762 |
| institution | Directory Open Access Journal |
| issn | 1664-0640 |
| language | English |
| last_indexed | 2024-12-21T22:26:26Z |
| publishDate | 2021-08-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Psychiatry |
| spelling | doaj.art-d882f314649747878dd7833db1ad87622022-12-21T18:48:12ZengFrontiers Media S.A.Frontiers in Psychiatry1664-06402021-08-011210.3389/fpsyt.2021.681418681418Safety and Efficacy of High-Dose Vitamin B6 as an Adjunctive Treatment for Antipsychotic-Induced Hyperprolactinemia in Male Patients With Treatment-Resistant SchizophreniaChuanjun Zhuo0Chuanjun Zhuo1Yong Xu2Yong Xu3Haibo Wang4Tao Fang5Tao Fang6Jiayue Chen7Jiayue Chen8Chunhua Zhou9Qianchen Li10Jie Liu11Shuli Xu12Cong Yao13Weiliang Yang14Anqu Yang15Bo Li16Yuhui Chen17Hongjun Tian18Hongjun Tian19Chongguang Lin20Key Laboratory of Multiple Organ Damages of Major Psychoses (MODMP_Lab), Tianjin Fourth Center Hospital, The Fourth Central Hospital Affiliated With Nankai University, The Fourth Central Hospital Affiliated to Tianjin Medical University, Tianjin, ChinaKey Laboratory of Real Time Brain Circuit Tracing in Neurology and Psychiatry (RTBNP_Lab), Tianjin Fourth Center Hospital, The Fourth Central Hospital Affiliated With Nankai University, The Fourth Central Hospital Affiliated to Tianjin Medical University, Tianjin, ChinaDepartment of Psychiatry, First Hospital/First Clinical Medical College of Shanxi Medical University, Taiyuan, ChinaMental Disorder Therapy Center for Cognitive Impairment and Sleep Disorders, First Hospital of Shanxi Medical University, Taiyuan, ChinaPeking University Clinical Research Institute, Peking University First Hospital, Beijing, ChinaKey Laboratory of Multiple Organ Damages of Major Psychoses (MODMP_Lab), Tianjin Fourth Center Hospital, The Fourth Central Hospital Affiliated With Nankai University, The Fourth Central Hospital Affiliated to Tianjin Medical University, Tianjin, ChinaKey Laboratory of Real Time Brain Circuit Tracing in Neurology and Psychiatry (RTBNP_Lab), Tianjin Fourth Center Hospital, The Fourth Central Hospital Affiliated With Nankai University, The Fourth Central Hospital Affiliated to Tianjin Medical University, Tianjin, ChinaKey Laboratory of Real Time Brain Circuit Tracing in Neurology and Psychiatry (RTBNP_Lab), Tianjin Fourth Center Hospital, The Fourth Central Hospital Affiliated With Nankai University, The Fourth Central Hospital Affiliated to Tianjin Medical University, Tianjin, ChinaLaboratory of Neuro-Imaging and Comorbidity (PNGC_Lab), Tianjin Anding Hospital Affiliated to Nankai University, Tianjin Medical University, Tianjin, ChinaDepartment of Pharmacology, The First Hospital Affiliated to Hebei Medical University, Shijiazhuang, ChinaDepartment of Pharmacology, The First Hospital Affiliated to Hebei Medical University, Shijiazhuang, ChinaLaboratory of Neuro-Imaging and Comorbidity (PNGC_Lab), Tianjin Anding Hospital Affiliated to Nankai University, Tianjin Medical University, Tianjin, ChinaLaboratory of Neuro-Imaging and Comorbidity (PNGC_Lab), Tianjin Anding Hospital Affiliated to Nankai University, Tianjin Medical University, Tianjin, ChinaLaboratory of Neuro-Imaging and Comorbidity (PNGC_Lab), Tianjin Anding Hospital Affiliated to Nankai University, Tianjin Medical University, Tianjin, ChinaLaboratory of Neuro-Imaging and Comorbidity (PNGC_Lab), Tianjin Anding Hospital Affiliated to Nankai University, Tianjin Medical University, Tianjin, ChinaDepartment of Treatment Resistant Schizophrenia, Tianjin Kangtai Hospital, Tianjin, ChinaDepartment of Treatment Resistant Schizophrenia, Tianjin Kangtai Hospital, Tianjin, ChinaDepartment of Treatment Resistant Schizophrenia, Tianjin Kangtai Hospital, Tianjin, ChinaKey Laboratory of Multiple Organ Damages of Major Psychoses (MODMP_Lab), Tianjin Fourth Center Hospital, The Fourth Central Hospital Affiliated With Nankai University, The Fourth Central Hospital Affiliated to Tianjin Medical University, Tianjin, ChinaKey Laboratory of Real Time Brain Circuit Tracing in Neurology and Psychiatry (RTBNP_Lab), Tianjin Fourth Center Hospital, The Fourth Central Hospital Affiliated With Nankai University, The Fourth Central Hospital Affiliated to Tianjin Medical University, Tianjin, ChinaDepartment of Psychiatry, Wenzhou Seventh Peoples Hospital, Wenzhou, ChinaThis study aimed to investigate the safety and efficacy of high-dose vitamin B6 (vB6) as an adjunct treatment for antipsychotic-induced hyperprolactinemia (AIHP) in male patients with treatment-resistant schizophrenia (TRS). In this randomized double-blinded controlled study, patients were randomized (1:1) into a control group given aripiprazole (ARI; 10 mg/day; n = 100) or an intervention group given vB6 (300 mg/12 h for 16 weeks; n = 100). Prolactin levels, psychotic symptoms [Positive and Negative Syndrome Scale (PANSS)], cognitive function [MATRICS Consensus Cognitive Battery (MCCB)], liver function, kidney function, growth hormone level, micronutrient levels, blood lipids, and adverse secondary effects (ASEs)[Treatment Emergent Symptom Scale (TESS) and Barnes-Akathisia scale] were monitored. After a 16-week treatment period, the vB6 group showed a 68.1% reduction in serum prolactin levels (from 95.52 ± 6.30 μg/L to 30.43 ± 18.65 μg/L) while the ARI group showed only a 37.4% reduction (from 89.07 ± 3.59 μg/L to 55.78 ± 7.39 μg/L). During weeks 1–4, both treatments reduced prolactin similarly. Subsequently, the ARI effect plateaued, while the vB6 effect remained robust. The vB6 group showed better alleviation of psychotic symptoms and cognitive impairment. No serious ASEs were observed; ASEs were more frequent in the ARI group. AIHP reduction efficacy of vB6 was associated with baseline prolactin and triglyceride levels, total vB6 dosage, and education level. In conclusion, compared with the ARI group, TRS patients given vB6 showed better attenuation of AIHP, lower ASE scores, and greater improvements in clinical symptoms and cognitive impairments. These results support further consideration of vB6 as a putative treatment for AIHP.Trial Registration: ChiCTR1800014755https://www.frontiersin.org/articles/10.3389/fpsyt.2021.681418/fullTRSaripiprazoledrug repurposingcognitive abilityPANSS |
| spellingShingle | Chuanjun Zhuo Chuanjun Zhuo Yong Xu Yong Xu Haibo Wang Tao Fang Tao Fang Jiayue Chen Jiayue Chen Chunhua Zhou Qianchen Li Jie Liu Shuli Xu Cong Yao Weiliang Yang Anqu Yang Bo Li Yuhui Chen Hongjun Tian Hongjun Tian Chongguang Lin Safety and Efficacy of High-Dose Vitamin B6 as an Adjunctive Treatment for Antipsychotic-Induced Hyperprolactinemia in Male Patients With Treatment-Resistant Schizophrenia Frontiers in Psychiatry TRS aripiprazole drug repurposing cognitive ability PANSS |
| title | Safety and Efficacy of High-Dose Vitamin B6 as an Adjunctive Treatment for Antipsychotic-Induced Hyperprolactinemia in Male Patients With Treatment-Resistant Schizophrenia |
| title_full | Safety and Efficacy of High-Dose Vitamin B6 as an Adjunctive Treatment for Antipsychotic-Induced Hyperprolactinemia in Male Patients With Treatment-Resistant Schizophrenia |
| title_fullStr | Safety and Efficacy of High-Dose Vitamin B6 as an Adjunctive Treatment for Antipsychotic-Induced Hyperprolactinemia in Male Patients With Treatment-Resistant Schizophrenia |
| title_full_unstemmed | Safety and Efficacy of High-Dose Vitamin B6 as an Adjunctive Treatment for Antipsychotic-Induced Hyperprolactinemia in Male Patients With Treatment-Resistant Schizophrenia |
| title_short | Safety and Efficacy of High-Dose Vitamin B6 as an Adjunctive Treatment for Antipsychotic-Induced Hyperprolactinemia in Male Patients With Treatment-Resistant Schizophrenia |
| title_sort | safety and efficacy of high dose vitamin b6 as an adjunctive treatment for antipsychotic induced hyperprolactinemia in male patients with treatment resistant schizophrenia |
| topic | TRS aripiprazole drug repurposing cognitive ability PANSS |
| url | https://www.frontiersin.org/articles/10.3389/fpsyt.2021.681418/full |
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