Number needed to treat and time to response/remission for quetiapine monotherapy efficacy in acute bipolar depression: Evidence from a large, randomized, placebo-controlled study
ABSTRACT The objectives of this analysis are to elucidate the clinical significance of antidepressant effects with quetiapine by evaluating number needed to treat as well as time to response and remission with quetiapine monotherapy in patients with acute bipolar depression. A post-hoc analysis was conducted of 542 patients with bipolar I or II disorder, (moderate to severe depression), randomized to 8 weeks of double-blind treatment with quetiapine 600 mg/day (n=180), quetiapine 300 mg/day (n=181), or placebo (n=181). Number needed to treat, time to response (> or =50% reduction from baseline in Montgomery-Asberg Depression Rating Scale total score) and time to remission (Montgomery-Asberg Depression Rating Scale total score < or =12) were evaluated. Response rates at week 8 were 58.2 and 57.6% for quetiapine 600 and 300 mg/day, respectively, and 36.1% for placebo (P<0.001). Remission rates were 52.9% for both quetiapine groups and 28.4% for placebo (P<0.001). The number needed to treat was five for both response and remission for quetiapine (600 and 300 mg/day) compared with placebo. Median time to response and remission were significantly shorter with quetiapine 600 and 300 mg/day than placebo. No between-group difference was found in the incidence of treatment-emergent mania or hypomania (quetiapine 600 mg/day: 2.2%, quetiapine 300 mg/day: 3.9, and placebo: 3.9%). In conclusion, quetiapine compared with placebo significantly reduces time to response and remission compared with placebo, and has a favorable number needed to treat.
- SourceAvailable from: Eduard Vieta
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- "Similar results were obtained from a recent study which was simultaneously negative for lithium (Young et al., 2008) and another study which was negative for paroxetine (McElroy et al., 2008). Post-hoc analysis suggests that the dose of 300 mg is not inferior to 600 mg in spite of a different effect size, and both are superior to placebo (Cookson et al., 2007) and improved secondary measures including qualityof-life indices (Endicott et al., 2007). It also suggests that quetiapine is effective against depression in rapidcycling bipolar I or II patients (Vieta et al., 2007a). "
ABSTRACT: This paper is a systematic review of the available data concerning the treatment of bipolar disorder: a systematic Medline search concerning treatment guidelines and clinical trials. The search for treatment guidelines returned 583 articles and 913 papers for RCTs. The search was last performed on 1 March 2008. An additional search included repositories of clinical trials and previous systematic reviews in order to trace especially older trials. The literature suggests that lithium is useful during the acute manic and the maintenance phase. Both first- and second-generation antipsychotics are efficacious in the treatment of acute mania. Quetiapine and the olanzapine-fluoxetine combination are also effective for treating bipolar depression, while olanzapine, quetiapine and aripiprazole are effective during the maintenance phase. Anticonvulsants, particularly valproate and carbamazepine have antimanic properties, whereas lamotrigine may be preferably effective in the treatment of depression but not mania. Antidepressants should always be used in combination with an antimanic agent because they were reported to induce switching to mania or hypomania, mixed episodes, and rapid cycling when given as monotherapy. The best evidence-based psychosocial interventions for bipolar disorder are group- and family-focused psychoeducation. Electroconvulsive therapy is an option for refractory patients. Although a variety of treatment options for bipolar disorder is currently available, their effectiveness is far from satisfactory, especially against bipolar depression and maintenance. Combination therapy may improve treatment outcome but it also carries the burden of more side-effects. Further research as well as the development of better guidelines and algorithms for step-by-step rational treatment are necessary.The International Journal of Neuropsychopharmacology 09/2008; 11(7):999-1029. DOI:10.1017/S1461145708009231 · 5.26 Impact Factor
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- "When fi rst published, initial fi ndings from BOLDER I led clinicians to believe that the magnitude of antidepressant effi cacy with quetiapine was large, though the confi rmatory BOLDER II trial indicates that quetiapine's effects are likely to be only moderate. A post-hoc analysis (Cookson et al 2007) was recently published on BOLDER I data which suggested that when translated into clinically meaningful terms, the data indicate that between 4 and 9 patients would have to be treated with quetiapine in order for one additional patient to achieve a response beyond what would be produced by placebo. This illustrates the unmet need that still exists for effective and tolerable antidepressant agents in the management of bipolar depression . "
ABSTRACT: The essential features of bipolar affective disorder involve the cyclical occurrence of high (manic or hypomanic episodes) and low mood states. Depressive episodes in both bipolar I and II disorder are more numerous and last for longer duration than either manic or hypomanic episodes. In addition depressive episodes are associated with higher morbidity and mortality. While multiple agents, including all 5 atypical antipsychotics, have demonstrated efficacy and earned US FDA indication for manic phase of bipolar illness, the acute treatment of bipolar depression is less well-studied. The first treatment approved by the US FDA for acute bipolar depression was the combination of the atypical antipsychotic olanzapine and the antidepressant fluoxetine. Recently, quetiapine monotherapy has demonstrated efficacy in the treatment of depressive episodes associated with both bipolar I and II disorder and has earned US FDA indication for the same.Neuropsychiatric Disease and Treatment 01/2008; 3(6):847-53. · 2.15 Impact Factor
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- "Use of antidepressants alone increases the risk of a switch to mania or hypomania and standard antidepressant medication, as compared with the use of mood stabilizers, is not associated with increased efficacy (Sachs et al. 2007). Therefore, there is a need for new therapies that provide a rapid onset of antidepressant efficacy, improved tolerability, and low risk of treatment emergent mania or cycle acceleration (Cookson et al. 2007). "
ABSTRACT: Background: "Difficult to treat depression" includes depression that inherently does not respond satisfactorily to one or more treatments that are optimally delivered. Quetiapine is effective for treatment for bipolar depression but its use in "difficult to treat bipolar depression" is yet to be explored. Objectives: To evaluate the effectiveness of quetiapine in "difficult to treat bipolar depression", as add on agent with mood stabilizers. Methods: Seven patients who had "difficult to treat depression" were treated with add on quetiapine to usual treatment and response to treatment was assessed. Results: Depression improved in all patients after add on quetiapine and maintained improvement for an average du- ration of follow-up of eleven months. Quetiapine was generally well tolerated without any significant side effects. Conclusions: The addition of quetiapine to usual treatment improves difficult to treat depression in bipolar disorder and is generally safe and well tolerated (German J Psychiatry 2010; 13: 41-44).