title: Adjunctive Aripiprazole Treatment for Risperidone-Induced Hyperprolactinemia: An 8-Week Randomized, Open-Label, Comparative Clinical Trial.
abstract: OBJECTIVE
  The present study aimed to evaluate the efficacy and safety of adjunctive aripiprazole treatment in schizophrenia patients with risperidone-induced hyperprolactinemia.
  
  
  METHODS
  One hundred and thirteen patients who were receiving a stable dose of risperidone were randomly assigned to either adjunctive aripiprazole treatment (10 mg/day) (aripiprazole group) or no additional treatment (control group) at a 1:1 ratio for 8 weeks. Schizophrenia symptoms were measured using the Positive and Negative Syndrome Scale (PANSS). Rating scales and safety assessments (RSESE, BARS, UKU) were performed at baseline and at weeks 4 and 8. Serum levels of prolactin were determined at baseline and at weeks 2, 4, 6 and 8. Metabolic parameters were determined at baseline and again at weeks 4 and 8.
  
  
  RESULTS
  One hundred and thirteen patients were enrolled in this study, and 107 patients completed the study (54 in the aripiprazole group, and 53 in the control group). PANSS-total scores in the aripiprazole group decreased significantly at week 4 (P = 0.003) and week 8 (P = 0.007) compared with the control group. PANSS-negative scores in the aripiprazole group also decreased significantly at week 4 (P = 0.005) and week 8 (P< 0.001) compared with the control group. Serum levels of prolactin in the aripiprazole group decreased significantly at week 2 (P< 0.001), week 4 (P< 0.001), week 6 (P< 0.001) and week 8 (P< 0.001) compared with the control group. There were no significant differences in changes of Fasting Plasma Glucose, Total cholesterol, Triglycerides and High Density Lipoprotein within each group at week 4 and 8 execpt low density lipoproteins. There was no significant difference in the incidence of adverse reactions between the two groups.
  
  
  CONCLUSIONS
  Adjunctive aripiprazole treatment may be beneficial in reducing serum levels of prolactin and improving negative symptoms in schizophrenia patients with risperidone-induced hyperprolactinemia.
  
  
  BACKGROUND
  chictr.org ChiCTR-IOR-15006278.
authors.affiliation: Department of Psychiatry, Henan Mental Hospital, The Second Affiliated Hospital of Xinxiang Medical University, Xinxiang, China; Henan Key Lab of Biological Psychiatry, Xinxiang Medical University, Xinxiang, China.
authors.forename: Jingyuan
authors.initials: J
authors.lastname: Zhao
authors.affiliation: Department of Psychiatry, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
authors.forename: Xueqin
authors.initials: X
authors.lastname: Song
authors.affiliation: Department of Psychiatry, Henan Mental Hospital, The Second Affiliated Hospital of Xinxiang Medical University, Xinxiang, China; Henan Key Lab of Biological Psychiatry, Xinxiang Medical University, Xinxiang, China.
authors.forename: Xiaoqing
authors.initials: X
authors.lastname: Ai
authors.affiliation: Department of Psychiatry, Henan Mental Hospital, The Second Affiliated Hospital of Xinxiang Medical University, Xinxiang, China; Henan Key Lab of Biological Psychiatry, Xinxiang Medical University, Xinxiang, China.
authors.forename: Xiaojing
authors.initials: X
authors.lastname: Gu
authors.affiliation: Department of Psychiatry, Henan Mental Hospital, The Second Affiliated Hospital of Xinxiang Medical University, Xinxiang, China; Henan Key Lab of Biological Psychiatry, Xinxiang Medical University, Xinxiang, China.
authors.forename: Guangbiao
authors.initials: G
authors.lastname: Huang
authors.affiliation: Department of Psychiatry, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
authors.forename: Xue
authors.initials: X
authors.lastname: Li
authors.affiliation: Department of Psychiatry, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
authors.forename: Lijuan
authors.initials: L
authors.lastname: Pang
authors.affiliation: Department of Psychiatry, Henan Mental Hospital, The Second Affiliated Hospital of Xinxiang Medical University, Xinxiang, China; Henan Key Lab of Biological Psychiatry, Xinxiang Medical University, Xinxiang, China.
authors.forename: Minli
authors.initials: M
authors.lastname: Ding
authors.affiliation: Department of Psychiatry, Henan Mental Hospital, The Second Affiliated Hospital of Xinxiang Medical University, Xinxiang, China; Henan Key Lab of Biological Psychiatry, Xinxiang Medical University, Xinxiang, China.
authors.forename: Shuang
authors.initials: S
authors.lastname: Ding
authors.affiliation: Department of Psychiatry, Henan Mental Hospital, The Second Affiliated Hospital of Xinxiang Medical University, Xinxiang, China; Henan Key Lab of Biological Psychiatry, Xinxiang Medical University, Xinxiang, China.
authors.forename: Luxian
authors.initials: L
authors.lastname: Lv
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D000068180:Aripiprazole / Q000627:therapeutic use*; D001786:Blood Glucose / Q000032:analysis; D015992:Body Mass Index; D002784:Cholesterol / Q000097:blood; D004334:Drug Administration Schedule; D005047:Etoposide; D005260:Female; D006801:Humans; D006966:Hyperprolactinemia / Q000139:chemically induced* / Q000150:complications; D008075:Lipoproteins, HDL / Q000097:blood; D008297:Male; D008942:Mitoxantrone; D011241:Prednisone; D011388:Prolactin / Q000097:blood; D011569:Psychiatric Status Rating Scales; D018967:Risperidone / Q000627:therapeutic use / Q000633:toxicity*; D012559:Schizophrenia / Q000150:complications / Q000188:drug therapy*; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood; D014750:Vincristine
chemical_list: D014150:Antipsychotic Agents; D001786:Blood Glucose; D008075:Lipoproteins, HDL; D014280:Triglycerides; D014750:Vincristine; D005047:Etoposide; D000068180:Aripiprazole; D011388:Prolactin; D002784:Cholesterol; D008942:Mitoxantrone; D018967:Risperidone; D011241:Prednisone