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Title: Extended-Release Quetiapine Effective in Treating Acute Schizophrenia: Presented at APA

"Extended-Release Quetiapine Effective in Treating Acute Schizophrenia: Presented at APA"

By Paula Moyer SAN DIEGO, CA -- May 24, 2007 -- A once-daily extended-release formulation of quetiapine (Seroquel) is effective in the treatment of acute schizophrenia, according to investigators who presented their findings here at the American Psychiatric Association 2007 Annual Meeting (APA). "Extended-release quetiapine is effective across a broad range of symptoms in acute schizophrenia," said principal investigator S. Charles Schulz, MD, department head, department of psychiatry, University of Minnesota, Minneapolis, United States. "In our study, we saw a therapeutically effective dose of the drug as early as day 2 of the study." The investigators conducted the study because of the concern regarding nonadherence to medication in patients with schizophrenia and the thought that less frequent dosing regimens could improve adherence. Therefore, in a 6-week, double-blind, randomised, placebo-controlled study, he and his coinvestigators evaluated the efficacy and safety of the once-daily extended-release formulation. They randomised 588 patients with acute schizophrenia into placebo, 1 of 3 doses of quetiapine, or immediate-release quetiapine. The extended-release arms received 400 mg/day, 600 mg/day, or 800 mg/day with dose escalation to 400 mg/day and 600 mg/day by day 2 and 800 mg/day by day 3. Those in the immediate-release group underwent a 5-day dose escalation until they reached a dose of 200 mg twice daily. The patients had to have a Positive And Negative Symptoms Scale (PANSS) total score of at least 70 and a Clinician's Global Impressions-Severity (CGI-S) of at least 4. The investigators wanted to determine the change in PANSS total score from baseline to day 42 or last observation carried forward (LOCF). They also wanted to know the percentage of patients responding by day 42, with response defined as a reduction in PANSS total score of at least 30% or a CGI-Improvement (CGI-I score of no more than 3, as well as changes from baseline to day 42 in various PANSS subscale scores and the CGI-S. The subscales are positive symptoms, negative symptoms, and general psychopathology, and the clusters under investigation were aggression and depression. The investigators also documented the adverse effects and other safety assessments. At the end of the study period, the average PANSS total score decreased significantly with the extended-release quetiapine formulation. The average decrease was 24.8 in the 400-mg/day group ([P <.05 compared with placebo); 30.9 in the 600-mg/day group (P <.001); and 31.3 in the 800-mg/day group (P <.001). The average decrease was 26.6 in the immediate-release quetiapine group (P <.01) and 18.8 in the placebo group.

The CGI response rates for all doses of the sustained-release quetiapine and immediate-release quetiapine were significantly higher than for placebo (P <.05). Improvements in the PANSS subscale and cluster scores were also observed for all sustained-release doses compared with placebo. The CGI-S scores improved significantly with the 600-mg/day and 800-mg/day doses of the sustained-release formulation and with the immediate-release formulation compared with placebo (P =.001, P <.001, and P =.033, respectively).

The investigators documented no unexpected adverse effects with the 3-day dose escalation of extended-release quetiapine. The most common adverse effects were somnolence and dizziness. Adverse effects that led to discontinuation occurred at rates of 5.3% in the 400-mg/day extended-release group, 2.7% in the 600-mg/day group, and 2.5% in the 800-mg/day group, and at rates of 4.9% in the immediate-release group and 2.5% in the placebo group. Three patients had orthostatic hypotension, 1 in the 800-mg/day group and 2 in the immediate-release group. Extrapyramidal symptoms occurred in 2.7% of the 400-mg/day extended-release group, 8.0% in the 600-mg/day group, and 4.1% in the 800-mg/day group, and in 4.9% of the immediate-release group and 5.1% of those on placebo.

Seroquel is manufactured by AstraZeneca, which sponsored the study.

[Presentation title: Efficacy of Once-Daily Quetiapine Sustained Release (SR) in Patients With Acute Schizophrenia. Abstract NR491]

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