Psychiatry Investig.  2017 Jan;14(1):63-73. 10.4306/pi.2017.14.1.63.

Efficacy and Safety of Bitopertin in Patients with Schizophrenia and Predominant Negative Symptoms: Subgroup Analysis of Japanese Patients from the Global Randomized Phase 2 Trial

• Hirayasu Y
• Sato SI
• Shuto N
• Nakano M
• Higuchi T

• KMID: 2365014
• DOI: http://doi.org/10.4306/pi.2017.14.1.63

Abstract

OBJECTIVE
The aim of the present study was to perform a subgroup analysis of data from a phase II global, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of bitopertin, a glycine reuptake inhibitor that activates N-methyl-D-aspartate receptors by increasing the concentration of glycine in the synaptic cleft, in Japanese and non-Japanese patients with schizophrenia and predominant negative symptoms.
METHODS
Patients with schizophrenia and predominant negative symptoms on one or two antipsychotic drugs, including atypical antipsychotic drugs (olanzapine, risperidone, quetiapine, aripiprazole, and paliperidone) as the primary treatment, received bitopertin (10, 30, or 60 mg/day) or placebo once daily for 8 weeks as an add-on treatment. Efficacy was assessed using the Positive and Negative Syndrome Scale (PANSS) negative symptom factor score (NSFS).
RESULTS
The efficacy of bitopertin (10 mg and 30 mg) was similar between Japanese and non-Japanese patients. In the bitopertin 60-mg group, no difference from the placebo group was observed in Japanese or non-Japanese patients. The response to placebo was lower in Japanese patients, and there was a trend towards a greater difference in the change in PANSS NSFS between the placebo group and the 10-mg and 30-mg groups among Japanese patients. The safety profile of bitopertin was favorable in Japanese and non-Japanese patients.
CONCLUSION
According to this subgroup analysis from a global phase II study of bitopertin, there was no difference in terms of efficacy and safety between Japanese and non-Japanese patients.

Keyword

Bitopertin; Japan; Negative symptoms; Schizophrenia; Placebo response

MeSH Terms

Antipsychotic Agents
Aripiprazole
Asian Continental Ancestry Group*
Glycine
Humans
Japan
Quetiapine Fumarate
Receptors, N-Methyl-D-Aspartate
Risperidone
Schizophrenia*
Antipsychotic Agents
Aripiprazole
Glycine
Quetiapine Fumarate
Receptors, N-Methyl-D-Aspartate
Risperidone