Switching From Twice-Daily to Once-Daily Clozapine Dosing in Schizophrenia

Condition(s) studied

Investigational drug(s) / intervention(s)

Clozapine: Switching from twice-daily to once-daily clozapine dosing regimen

Study summary

Plasma half-life has routinely been used to establish the dosing schedule of antipsychotics; for example, it is recommended that agents with a short plasma half-life be administered multiple times per day. However, to date, several randomized controlled trials (RCTs) have shown no differences in clinical outcomes between once- and twice-daily dosing of various antipsychotics, suggesting that once-daily dosing of antipsychotics is a viable option regardless of plasma half-life. This would apply to clozapine as well; however, there have been no studies comparing once-daily vs. twice-daily dosing regimens of clozapine in terms of efficacy and tolerability. To address this gap in the literature, the investigators shall conduct a pilot, double-blind, RCT to examine efficacy and tolerability following a switch to once-daily dosing regimen of clozapine in patients with schizophrenia receiving clozapine twice a day.

Eligibility

Primary outcome measure(s)

• Brief Psychiatric Rating 18 item Scale (BPRS 18 item scale) — 0 and 12 weeks
  Change in BPRS total scores from baseline to 12 weeks Total scores range from 18-126, higher scores represent worse clinical outcomes: \<31 = Illness not significant \>=31 = Mildly ill \>41 = Moderately ill \>53 = Markedly ill.

Trial sites (1)

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