Table 1.

Concomitant drugs

Study protocol for concomitant drugs
Concomitant use of antipsychotics
BNS01 study	Based on the clinical symptoms, physicians determined the concomitant patterns (1) or (2)
	Pattern (1) No prior antipsychotics, or prior antipsychotics could be switched to BNS monotherapy:  BNS monotherapy was started  If symptoms could not be controlled by dose adjustment of BNS, concomitant use of antipsychotics was permitted	Pattern (2) Prior antipsychotics could not be discontinued:  BNS was added to the prior antipsychotics  Continuous use of prior antipsychotics was permitted, but risperidone, quetiapine fumarate, perospirone hydrochloride and olanzapine were prohibited
	Following antipsychotics were prohibited: risperidone, quetiapine fumarate, perospirone hydrochloride, and olanzapine	Depending on the symptom severity, concomitant antipsychotics were reduced and discontinued if possible
	Concomitant antipsychotics were reduced/discontinued if the symptoms were relieved	If symptoms could not be controlled by dose adjustment of BNS, additional antipsychotic use (including dose increase) was permitted
BNS02 study	Basically, BNS was administered as monotherapy. Concomitant antipsychotics were prohibited except for HAL
	Pattern (1) No prior antipsychotics, or prior antipsychotics could be switched to BNS monotherapy:  BNS monotherapy was started  If symptoms could not be controlled by dose adjustment of BNS, concomitant use of HAL was permitted  Concomitant HAL was reduced/discontinued when the symptoms were relieved	Pattern (2) Prior antipsychotics could not be discontinued:  Regimen was simplified to HAL (up to 12 mg/day) while considering chlorpromazine equivalent dosage  If HAL could not be discontinued at the start of BNS, concomitant use of HAL up to 12 mg/day was permitted  HAL was discontinued by week 12 while adjusting the dose of BNS  If necessary, concomitant use of HAL was allowed after week 12  Concomitant HAL was reduced/discontinued when the symptoms were relieved
Concomitant use of antiparkinsonian drugs
BNS01 study & BNS02 study	If an antiparkinsonian drug was used before the start of BNS, continued use of it was permitted; otherwise its use was prohibited. If extrapyramidal symptoms developed or worsened, antiparkinsonian drugs could be used appropriately. In BNS01 study, antiparkinsonian drugs were tapered off and terminated if possible for patients with a score of < 2 for each of the seven Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS) items
Concomitant use of other psychotropics
BNS01 study & BNS02 study	If a psychotropic drug was used before the start of BNS, the continuous use of it was permitted. If symptoms such as insomnia developed or worsened, the use of psychotropic drugs was permitted as appropriate. In BNS02 study, concomitant use of vegetamin or levomepromazine was prohibited

BNS blonanserin, HAL haloperidol