Quetiapine, a novel antipsychotic: experience in elderly patients with psychotic disorders. Seroquel Trial 48 Study Group

J Clin Psychiatry. 1999 May;60(5):292-8.


Background: This uncontrolled trial examines the safety and effects of quetiapine, a new atypical antipsychotic, in elderly patients with psychotic disorders.

Method: This is an ongoing, multicenter, open-label, 52-week trial of quetiapine in men and women at least 65 years old with DSM-IV psychotic disorders. Patients received quetiapine, 25 to 800 mg/day. Assessments included the 18-item Brief Psychiatric Rating Scale (BPRS), the Clinical Global Impressions scale (CGI), the Simpson-Angus Neurologic Rating Scale, and the Abnormal Involuntary Movement Scale (AIMS).

Results: An interim analysis was performed at 12 weeks with results from 151 patients. The median total daily dose was 100 mg/day. The most common adverse events were somnolence (32%), dizziness (14%), postural hypotension (13%), and agitation (11%). Extrapyramidal symptom adverse events occurred in 6% of patients. Mean Simpson-Angus Scale total score showed significant (p<.0001) improvement at endpoint; there were no changes in AIMS scores. BPRS total and CGI-Severity of Illness scores showed significant (p<.0001 and p<.01, respectively) improvement at endpoint. No clinically important effects were reported for hematologic or liver function test variables; small changes in mean free levorotatory thyroxine (T4) levels were not associated with substantial changes in mean thyroid-stimulating hormone concentration. Mean corrected QT interval (QTc) was unchanged, but a slight increase in mean heart rate was noted.

Conclusion: Quetiapine was well tolerated in a nonrandomized study of elderly patients and was associated with improvement in symptoms.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Akathisia, Drug-Induced / etiology
  • Antipsychotic Agents / administration & dosage
  • Antipsychotic Agents / adverse effects
  • Antipsychotic Agents / therapeutic use*
  • Brief Psychiatric Rating Scale / statistics & numerical data
  • Dibenzothiazepines / administration & dosage
  • Dibenzothiazepines / adverse effects
  • Dibenzothiazepines / therapeutic use*
  • Dizziness / chemically induced
  • Drug Administration Schedule
  • Female
  • Humans
  • Hypotension, Orthostatic / chemically induced
  • Male
  • Psychiatric Status Rating Scales / statistics & numerical data
  • Psychotic Disorders / drug therapy*
  • Psychotic Disorders / psychology
  • Quetiapine Fumarate
  • Sleep / drug effects
  • Treatment Outcome


  • Antipsychotic Agents
  • Dibenzothiazepines
  • Quetiapine Fumarate