The efficacy and tolerability of quetiapine in the treatment of acute mania were reviewed.
Five randomized, placebo-controlled trials involving quetiapine as monotherapy or adjunct therapy in combination with either divalproex or lithium in the treatment of bipolar mania in either adolescents or adults were identified and reviewed. The primary outcome measure used in the trials was a change in Young Mania Rating Scale total scores. Monotherapy trials evaluated quetiapine, lithium, haloperidol, and placebo. Quetiapine was superior to placebo in both trials. Quetiapine and lithium showed comparable efficacy in one study, though lithium serum concentrations may have been suboptimal. Haloperidol was superior to quetiapine in efficacy at day 21 but similar at day 84. In the two trials evaluating quetiapine or placebo as adjunct therapy to lithium or divalproex, quetiapine was significantly more efficacious than placebo in one trial. In adolescents, quetiapine was more effective than placebo as an adjunct to divalproex. The most common adverse effects clearly attributable to quetiapine in these trials were somnolence and dry mouth. Quetiapine did not induce extrapyramidal effects, but weight gain was notable with the drug.
While quetiapine treatment demonstrated efficacy in the majority of the studies, the robustness of its efficacy is questionable. The use of quetiapine as first-line therapy for acute mania is not recommended based on the available results and cost considerations. However, it may be a useful second-line agent, particularly when sensitivity to extrapyramidal symptoms limits treatment options.
"As monotherapy, quetiapine has proven more effective than lithium in the treatment of depression at doses ranging from 150 to 600 mg [6,7], with no significant difference found between 300 and 600 mg doses . The drug has also shown similar efficacy in the treatment of mania at doses of between 600 and 800 mg compared with lithium after 4 weeks and with haloperidol after 84 days [9-11], although response in mania was slower when compared with haloperidol . To date, quetiapine is the only antipsychotic medication with evidence of efficacy across all phases of bipolar disorder , and was recently indicated as the first choice in monotherapy for the treatment of bipolar depression [12,13]. "
[Show abstract][Hide abstract] ABSTRACT: The treatment of bipolar disorder (BD) remains a challenge due to the complexity of the disease. Current guidelines represent an effort to assist clinicians in routine practice but have several limitations, particularly concerning long-term treatment. The ARIQUELI (efficacy and tolerability of the combination of lithium or aripiprazole in young bipolar non or partial responders to quetiapine monotherapy) study aims to evaluate two different augmentation strategies for quetiapine nonresponders or partial responders in acute and maintenance phases of BD treatment.
The ARIQUELI study is a single-site, parallel-group, randomized, outcome assessor-blinded trial. BD I patients according to the DSM-IV-TR, in depressive, manic/hypomanic or mixed episode, aged 18 to 40 years, are eligible. After diagnostic assessments, patients initiated treatment in phase I with quetiapine. Nonresponders or partial responders after 8 weeks are allocated into one of two groups, potentiated with either lithium (0.5 to 0.8 mEq/l) or aripiprazole (10 or 15 mg). Patients will be followed up for 8 weeks in phase I (acute treatment), 6 months in phase II (continuation treatment) and 12 months in phase III (maintenance treatment). Outcome assessors are blinded to the treatment. The primary outcome is the evaluation of changes in mean scores on the CGI-BP-M between baseline and the endpoint at the end of each study phase.
The ARIQUELI study is currently in progress, with patients undergoing acute treatment (phase I), potentiation (phase II) and maintenance (phase III). The study will be extended until January 2015. Trials comparing lithium and aripiprazole with potentiate treatment in young BD I nonresponders to quetiapine in monotherapy can provide relevant information on the safety of these drugs in clinical practice. Long-term treatment is an issue of great importance and should be evaluated further through more in-depth studies given that BD is a chronic disease.Trial registration: ClinicalTrials.gov identifier: NCT01710163.
"In the bipolar spectrum disorders quetiapine is approved for the treatment of acute manic and mixed episodes associated with bipolar I disorder (Bowden et al., 2005; Brahm et al., 2007). It is also approved for the treatment of acute bipolar depressive episodes and as adjunctive maintenance therapy of bipolar I disorder with lithium or valproate (Thase et al., 2006; Vieta et al., 2008; Suppes et al., 2009). "
American journal of health-system pharmacy: AJHP: official journal of the American Society of Health-System Pharmacists 02/2008; 65(2):114-5; author reply 115-6. DOI:10.2146/ajhp070440 · 1.88 Impact Factor
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