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Quetiapine Equivalent to Haloperidol in Acute Schizophrenia: Presented at ECNP

By Paula Moyer

PRAGUE, CZECH REPUBLIC -- October 7, 2003 -- Quetiapine (Seroquel) is as effective in treating schizophrenia in the emergency setting as haloperidol (Haldol), and may be more effective at addressing negative symptoms, a study presented here September 21^st at the 16^th Congress of the European College of Neuropsychopharmacology.

"We also saw an extremely mild profile regarding extrapyramidal side effects [EPS]," said Bilgen Taneli, MD, psychiatry department, Uludag University Medical School, Bursa, Turkey. "This difference may be attributed to quetiapine's high affinity for 5-HT2A receptors and its comparatively low affinity for D1 and D2 receptors."

Because haloperidol is often the first-line therapy used in acute settings, Dr. Taneli and colleagues wanted to evaluate its efficacy and tolerability in acute episodes of chronic and sub-chronic schizophrenia against that of quetiapine. Their multicenter, open-labelled, randomised, parallel-group clinical trial enrolled 94 patients with such exacerbations.

Patients were treated with one of the two agents for 12 weeks at 17 psychiatry clinics in Turkey. Treating physicians titrated the medications over a 4-day period. The mean dose of quetiapine was 487 mg daily and that of haloperidol was 10 mg daily. The maximum daily doses were 750 mg for quetiapine and 20 mg for haloperidol.

To assess efficacy, the investigators used the Positive and Negative Symptoms Scale (PANSS) as a primary instrument and the Clinical Global Impression - Severity of Illness Scale (CGI-SI) as a secondary instrument. To assess tolerability, they used the Simpson-Angus Scale (SAS) as a primary instrument and the Abnormal Involuntary Movement Scale (AIMS) as a secondary instrument. The Approaches to Schizophrenia Communication Self-Report (ASC-SR) served as a quality-of-life measure.

The reductions in PANSS-Total scores were similar for the two groups, with a baseline average 98 for the haloperidol and post-treatment average of 72. For the quetiapine group, the baseline average PANSS-total score was 101, with a post-treatment average of 75.

Mean scores on the subscales for negative, positive and general psychopathology significantly improved in both groups during the study period, according to Dr. Taneli (P<0.05). The differences between groups were not significant. However, a secondary analysis showed that significantly more quetiapine-treated patients had a reduction of at least 40% in the PANSS negative subscale, with a mean reduction of 47%. In the haloperidol group, the mean reduction in that subscale was 25% (P<0.05).

The patients' change in CGI-SI scores was statistically significant a well (P<0.05). In the haloperidol the change in average score dropped from 5.0 at baseline to 3.5 after treatment. In the quetiapine group, the baseline averaged dropped from 5.1 to 3.7. These responses were similar, Dr. Taneli said.

The tolerability scores showed some advantage to treatment with quetiapine, he added. The SAS scores showed that 51% of the patients in quetiapine group exhibited improvement and 9% worsened. In the haloperidol group 27% improved and 50% worsened, a difference between groups that Dr. Taneli said was significant (P<0.05). In the quetiapine group, the proportion of patients with normal AIMS scores gradually increased during the entire treatment period and reached statistical significance from Week 4 onwards. In the haloperidol group, there were no significant changes. The investigators also documented more EPS in the haloperidol group, Dr. Taneli said.

In the haloperidol group, 65% of patients were received concomitant medication compared to 29% in the quetiapine group (P<0.05). The mean ASC-SR scores of quetiapine group exhibited statistically significant improvement and no worsening, in contrast to the haloperidol group (P<0.05).


[Study title: Comparison of Efficacy and Tolerability of Quetiapine and Haloperidol in Acute Exacerbation of Chronic or Subchronic Schizophrenia. Abstract P.2.020]

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