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Table 1 Concomitant drugs

From: Long-term oral blonanserin treatment for schizophrenia: a review of Japanese long-term studies

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

  1. BNS blonanserin, HAL haloperidol