SEROQUEL Effective in Treating Depressive Symptoms in People with Psychotic Disorders

Depressive symptoms are common in people with psychotic disorders, such as schizophrenia and other psychotic mood disorders, and can have devastating effects, including decreased energy, difficulty sleeping, an inability to enjoy life, and loss of interest in daily activities. These symptoms are associated with poor outcomes, increased risk of relapse, and high suicide rates. A study presented at the American Psychiatric Association Annual Meeting has found that the atypical antipsychotic SEROQUEL(R) (quetiapine fumarate) Tablets is effective in treating depressive symptoms in people with schizophrenia and other psychotic disorders.

Key Takeaways:

  • The study found that SEROQUEL produced a statistically significant greater improvement in depressive symptoms, measured by the Hamilton Rating Scale for Depression (HAMD), compared to risperidone (44.6% vs. 34.4%, p=0.0015).
  • SEROQUEL produced a greater effect than risperidone in patients who had the most severe depressive symptoms, scoring high (greater than or equal to 20) on the initial HAMD test.
  • The study included 751 adults with psychoses, who were randomized in a 3:1 ratio of SEROQUEL to risperidone, and were assessed using the HAMD tool.
  • SEROQUEL was well tolerated by more than 4,000 male and female patients in clinical trials, with a low incidence of hormonal, reproductive, and anticholinergic side effects.
  • The efficacy of SEROQUEL was demonstrated in a dose range of 150 mg/day to 750 mg/day, with an initial target dose range of 300-400 mg given in two divided doses daily.
  • SEROQUEL has been prescribed for over 1.3 million patients in the United States since its approval in September of 1997, with nearly 2 million prescriptions written.
  • Common adverse events exhibited across placebo-controlled trials included headache (19%), somnolence (18%), and dizziness (10%), with the majority of events rated mild or moderate.
  • AstraZeneca, the manufacturer of SEROQUEL, has a major international health care business with health care sales of $15 billion and leading positions in sales of gastrointestinal, oncology, anesthesia, cardiovascular, CNS, and respiratory products.

Statistics:

  • 44.6% of patients in the SEROQUEL group experienced a significant improvement in depressive symptoms, measured by the HAMD, compared to 34.4% in the risperidone group (p=0.0015).
  • 751 adults with psychoses participated in the study, which was a four-month, open-label trial.
  • 3:1 ratio of SEROQUEL to risperidone was used in the study.
  • 4,000 male and female patients were involved in clinical trials with SEROQUEL.
  • 1.3 million patients have been prescribed SEROQUEL in the United States since its approval in September of 1997.
  • 2 million prescriptions have been written for SEROQUEL in the United States since its approval.

Sources:

  • (1) Sajatovic M, Mullen J, Sweitzer D. Mood Response to Quetiapine and Risperidone. Poster presented at the American Psychiatric Association Annual Meeting in Chicago, May 13 - 18, 2000.
  • (2) Atypical Antipsychotics for Treatment of Depression in Schizophrenia and Affective Disorders. Journal of Clinical Psychiatry. 1998; 59 [supply 12]: 41-45.
  • (3) U.S. Department of Health and Human Services. Diagnosis and Treatment of Depression in Late Life. 1991.
  • (4) Hamilton M. A Rating Scale for Depression. J Neurol Neurosurg Psychiatry. 1960;23:56-62.
  • (5) Source(TM) Prescription Audit (SPA) 29-Month Period Ending March 2000, Scott Levin, a division of PMSI Scott-Levin, Inc.
  • (6) NDC Health Information Services, SEROQUEL Patient Tracking Analysis. 29-Month Period Ending March 2000.