Effect of various doses aripiprazole on hyperprolactinemia induced by amisulpride and risperidone

Objective To investigate the efficacy and safety of different doses of aripirazole on hyperlactinemia induced by amisulpride and risperidone. Methods 87 patients with hyperlactinemia induced by amisulpride were randomly assigned to three groups on the basis of original medication combined with aripiprazole 5 mg/d, 10 mg/d and 15 mg/d (Ami+5 mg, Ami+10 mg, Ami+15 mg) with 29 cases in each group.106 patients with hyperlactinemia induced by risperidone were randomly assigned to three groups on the basis of original medication combined with aripiprazole 5 mg/d (36 cases), 10 mg/d (35 cases) and 15 mg/d (35 cases). The plasma prolactin (PRL) level was measured before and after 4th,8th and 12th week treatment. The Positive and Negative Syndrome Scale (PANSS) and Treatment Emergent Symptom Scale (TESS) were assessed for psychotic symptoms and adverse effects. Results The level of PRL of Ami+5 mg, Ami+10 mg and Ami+15 mg group had no statistical difference within and between groups at 4th,8th and 12th week. The level of PRL of Ris+5 mg , Ris+10 mg and Ris+15 mg group were significantly lower than that of baseline at each visit after baseline. The level of PRL of Ris+5 mg group ((38.9±19.0) nmol/L vs. (11.0±8.1) nmol/L), Ris+ 10 mg group ((36.2±16.5) nmol/L vs. (8.8±7.3) nmol/L) and Ris+ 15 mg group((35.6 ± 14.8) nmol/L vs. (9.2±7.6) nmol/L) at baseline were significantly different from which at the 12th week (t=4.129, 4.798,4.506;all P<0.01). The remission rates of symptoms relevant with hyperlactinemia in Ris+5 mg group, Ris+10 mg group and Ris+15 mg group were 66.67% (24/36), 62.86% (22/35), 51.43% (18/35) respectively. There were no difference of the remission rate of symptoms relevant with hyperlactinemia among those three groups. There were no difference of PANSS score within groups at 12th week except Ami+15 mg group, Ris+ 10 mg group and Ris+15 mg group(t=2.419, 2.406, 2.631, all P<0.05). The adverse effect rate of Ami+15 mg group (52%(15/29)) was significantly higher than that of Ami+5 mg group(17%(5/29), t=3.521, P<0.01) and Ami+10 mg group (24% (7/29), t=2.348, P<0.05). The adverse effect rate of Ris+15 mg group (34%(12/35)) was significantly higher than that of Ris+ 5 mg group (11%(4/36), t=2.203, P<0.05) and Ris+10 mg group (11% (4/35), t=2.314, P<0.05). Conclusion Various dose of aripiprazole did not show improvement in hyperprolactinemia induced by amisulpride, However that could significantly decrease PRL level in hyperprolactinemia induced by risperidone, and considering efficacy and safety, 5 mg/d aripirazole may be the best combination dose. Key words: Hyperprolactinemia; Schizophrenia; Amisulpride; Risperidone; Aripiprazole