A random-assignment, double-blind, clinical trial of once- vs twice-daily administration of quetiapine fumarate in patients with schizophrenia or schizoaffective disorder: a pilot study

Can J Psychiatry. 2003 Apr;48(3):187-94. doi: 10.1177/070674370304800307.

Abstract

Objective: To evaluate the efficacy and safety of administering quetiapine once vs twice daily.

Method: Utilizing a double-blind design, 21 hospitalized adult men or women with DSM-IV schizophrenia or schizoaffective disorder, who had received unchanged doses (for 2 weeks) of either 400 or 600 mg daily of quetiapine administered in 2 doses, were randomly assigned to once- or twice-daily administration for 4 weeks and then crossed over to the opposite dosing regimen for an additional 4 weeks. Standard psychopathology and safety measures were used in the study.

Results: Nearly 70% (15/21) of the subjects met the a priori efficacy responder criteria with no statistical differences in response between those assigned to once- or twice-daily quetiapine administration. Statistical analyses confirmed that most subjects maintained efficacy during the switch to once- or twice-daily administration with quetiapine. A minority (15%) did experience worsening of symptoms or orthostatic hypotension during the crossover. Quetiapine was generally well tolerated at either twice- or once-daily administration.

Conclusions: These pilot data suggest that it is clinically feasible to switch most quetiapine-treated subjects receiving a therapeutic twice-daily dosing schedule to a once-daily regimen. A minority may experience worsening of symptoms or orthostatic hypotension during the switch. This strategy of administering quetiapine entirely at bedtime may promote improved adherence to treatment.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Anticarcinogenic Agents / administration & dosage
  • Anticarcinogenic Agents / therapeutic use*
  • Antipsychotic Agents / administration & dosage
  • Antipsychotic Agents / therapeutic use*
  • Cross-Over Studies
  • Dibenzothiazepines / administration & dosage
  • Dibenzothiazepines / therapeutic use*
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Fumarates / administration & dosage
  • Fumarates / therapeutic use*
  • Humans
  • Male
  • Middle Aged
  • Pilot Projects
  • Psychotic Disorders / drug therapy*
  • Psychotic Disorders / psychology
  • Quetiapine Fumarate
  • Schizophrenia / drug therapy*
  • Schizophrenic Psychology

Substances

  • Anticarcinogenic Agents
  • Antipsychotic Agents
  • Dibenzothiazepines
  • Fumarates
  • Quetiapine Fumarate
  • fumaric acid