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Quetiapine Better Than Lithium for Maintenance Treatment of Bipolar I Disorder After Stabilisation With Quetiapine: Presented at EPA

By Chris Berrie

LISBON, Portugal -- January 26, 2009 -- Maintenance monotherapy with the atypical antipsychotic quetiapine significantly improves time to recurrence of any mood event over a switch to placebo for patients with bipolar I disorder stabilised with quetiapine, according to results from a multicentre, randomised, double-blind, placebo-controlled trial.

Furthermore, a switch to lithium treatment confers no benefits over continuation with quetiapine, said investigator Willem Nolen, MD, PhD, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands.

Dr. Nolen presented the study findings here on January 25 at the 17th European Congress of Psychiatry, organised by the European Psychiatric Association (EPA).

Quetiapine is an effective treatment for patients with bipolar I disorder as an adjunct to treatment with lithium or divalproex. However, Dr. Nolen noted, "This study was necessary to show that quetiapine also as monotherapy is efficacious in the long-term treatment of patients who are stabilised to treatment with quetiapine for acute mania or acute depression."

In their study, Dr. Nolen and colleagues enrolled 2,438 patients (manic, 1,174; depressed, 710; mixed, 554) aged 18 years or more and experiencing a current episode of bipolar I disorder, with 1 or more episodes in 2 years prior to the index episode. All patients had been receiving open-label quetiapine 300 to 800 mg/day twice daily.

They excluded patients with a recent anxiety disorder, substance abuse/dependence, quetiapine or lithium intolerance, and associated unstable illnesses.

Those patients who had achieved disease stabilisation, defined as a Young Mania Rating Scale (YMRS) total score no greater than 12 and a Montgomery-Äsberg Depression Rating Scale (MADRS) total score no greater than 12 for at least 4 weeks, entered the randomisation phase (intention-to-treat population).

A total of 404 patients were randomised to placebo, 404 continued quetiapine 300 to 800 mg/day twice daily, and 364 were switched to lithium 600 to 1,800 mg/day.

The 3 groups had similar mean ages and ratios of men to women. No significant baseline differences were seen across groups in total rating scores for YMRS and MDRS.

The primary outcome was time to recurrence of any mood event, while secondary endpoints were recurrence of manic or depressive event and all-cause discontinuation of treatment. Changes from baseline for interepisode mood symptom severity, functioning, cognitive symptoms, and work productivity were determined according to various rating scales.

Compared with placebo, time to recurrence of any mood event was significantly greater in patients who continued quetiapine treatment (hazard ratio [HR], 0.29; 95% confidence interval [CI], 0.23-0.38; P < .0001) and in those who switched to lithium (HR, 0.46; 95% CI, 0.36-0.59; P < .0001).

Continuing with quetiapine was significantly more effective than switching to lithium (HR, 0.66; 95% CI, 0.49-0.88; P = .005).

Quetiapine and lithium were both more effective than placebo for increased time to all-cause treatment discontinuation. Similarly, the secondary endpoints demonstrated further quetiapine and lithium benefits over placebo, Dr. Nolan said.

Both quetiapine and lithium were generally well tolerated, with their overall safety profiles consistent with those reported previously.

While lithium prevented the overall bipolar episodes, Dr. Nolen noted that, "in contrast to the other atypical antipsychotics, [quetiapine] not only prevents the manic episodes, but it also prevents the depressive episodes, which is rather unique to this compound."

Funding for this study was provided by AstraZeneca.


[Presentation title: Quetiapine or Lithium Versus Placebo for Maintenance Treatment of Bipolar I Disorder After Stabilisation on Quetiapine. Abstract P1161]

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