A Double-Blind, Placebo-Controlled Study of Quetiapine and Paroxetine as Monotherapy in Adults With Bipolar Depression (EMBOLDEN II)

McElroy, Susan L.; Weisler, Richard H.; Chang, William; Olausson, B.; Paulsson, Björn; Brecher, Martin; Agambaram, V.; Merideth, Charles H.; Nordenhem, Arvid; Young, Allan H.

doi:10.4088/jcp.08m04942gre

Cited by 273 publications

(264 citation statements)

References 47 publications

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“…Pooled analyses of five identically designed trials demonstrated that quetiapine was superior to placebo, and moreover was equally effective for acute depression in BDI and BDII 243, 437. The latter finding must be reconciled with the fact that quetiapine beat placebo in only three of the five individual trials in patients with BDII, compared to all five in patients with BDI 253, 290, 438, 439, 440. This is probably because the smaller sample of BDII patients—only about half as many patients with BDII as BDI were enrolled in each of the trials—provided less statistical power for BDII.…”

Section: Bipolar II Disordermentioning

confidence: 99%

“…Antidepressants should not be used as monotherapy in patients with BDI depression, as available trials do not support their efficacy and there are concerns about their safety in terms of mood switching (level 2 negative) 260, 289, 290, 291…”

Section: Acute Management Of Bipolar Depressionmentioning

confidence: 99%

“…Further, secondary analyses from several RCTs indicate that quetiapine monotherapy significantly reduces symptoms of GAD and panic disorder in patients with bipolar depression 290, 313, 725. Negative trials include risperidone versus placebo in patients with BD and comorbid GAD and/or panic disorder726 and ziprasidone versus placebo in a similar trial 727…”

Section: Specific Populationsmentioning

confidence: 99%

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Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder

et al. 2018

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The Canadian Network for Mood and Anxiety Treatments (CANMAT) previously published treatment guidelines for bipolar disorder in 2005, along with international commentaries and subsequent updates in 2007, 2009, and 2013. The last two updates were published in collaboration with the International Society for Bipolar Disorders (ISBD). These 2018 CANMAT and ISBD Bipolar Treatment Guidelines represent the significant advances in the field since the last full edition was published in 2005, including updates to diagnosis and management as well as new research into pharmacological and psychological treatments. These advances have been translated into clear and easy to use recommendations for first, second, and third‐ line treatments, with consideration given to levels of evidence for efficacy, clinical support based on experience, and consensus ratings of safety, tolerability, and treatment‐emergent switch risk. New to these guidelines, hierarchical rankings were created for first and second‐ line treatments recommended for acute mania, acute depression, and maintenance treatment in bipolar I disorder. Created by considering the impact of each treatment across all phases of illness, this hierarchy will further assist clinicians in making evidence‐based treatment decisions. Lithium, quetiapine, divalproex, asenapine, aripiprazole, paliperidone, risperidone, and cariprazine alone or in combination are recommended as first‐line treatments for acute mania. First‐line options for bipolar I depression include quetiapine, lurasidone plus lithium or divalproex, lithium, lamotrigine, lurasidone, or adjunctive lamotrigine. While medications that have been shown to be effective for the acute phase should generally be continued for the maintenance phase in bipolar I disorder, there are some exceptions (such as with antidepressants); and available data suggest that lithium, quetiapine, divalproex, lamotrigine, asenapine, and aripiprazole monotherapy or combination treatments should be considered first‐line for those initiating or switching treatment during the maintenance phase. In addition to addressing issues in bipolar I disorder, these guidelines also provide an overview of, and recommendations for, clinical management of bipolar II disorder, as well as advice on specific populations, such as women at various stages of the reproductive cycle, children and adolescents, and older adults. There are also discussions on the impact of specific psychiatric and medical comorbidities such as substance use, anxiety, and metabolic disorders. Finally, an overview of issues related to safety and monitoring is provided. The CANMAT and ISBD groups hope that these guidelines become a valuable tool for practitioners across the globe.

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Section: Bipolar II Disordermentioning

confidence: 99%

Section: Acute Management Of Bipolar Depressionmentioning

confidence: 99%

Section: Specific Populationsmentioning

confidence: 99%

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Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder

et al. 2018

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“…The NICE [16] and CANMAT [11] guidelines now recommend QTP as the first-line drug, especially for the more severe pathophysiology of acute mania, due to its rapid and potent antimanic effects. Meanwhile, the efficacy of QTP monotherapy in acute bipolar depression has been consistently confirmed by such double-blind, placebo-controlled studies as BOLDER (BipOLar DEpRession) I/II [8,20] and EMBOLDEN (Efficacy of Monotherapy SEROQUEL in BipOLar DEpressioN) I/II [17,21]. The latter EMBOLDEN studies also examined the efficacy of QTP monotherapy in relapse prevention for bipolar disorders, and the results suggested that the preventive effect of QTP monotherapy is superior to that of placebo for both manic and depressive recurrence, and is superior to that of Li for depressive recurrence [11], and that the efficacy of Li or VPA for relapse prevention of any mood episode is clearly augmented by QTP coadministration [10,22].…”

Section: Qtpmentioning

confidence: 84%

How can we classify “mood stabilizers” with different properties?

Kondo

2011

CNPT

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Mood stabilizers have been conventionally defined as drugs possessing efficacy in both acute and maintenance therapy for any polarity of bipolar disorder. Only lithium has been regarded as the gold standard mood stabilizer, fulfilling all of these conditions. Recently, evidence for the comprehensive mood-stabilizing effects of second-generation antipsychotics such as quetiapine and olanzapine has been found, although their safety in long-term use is still of great concern. Antiepileptic drugs do not appear to be ideal mood stabilizers because of selective effectiveness on a particular polarity --for example, valproate and carbamazepine are predominantly antimanic, and lamotrigine is predominantly antidepressive. However, the mood-stabilizing effects of combinations of these drugs may be equivalent or even superior to that of lithium alone, especially in pathophysiologies less responsive to lithium, such as dysphoric mania, mixed features and rapid cycling.

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“…32 In 2007, a large trial found no benefit associated with the addition of paroxetine or bupropion to a mood stabiliser; 33 another reported that paroxetine was no better at achieving a durable recovery than placebo. 34 A recent updated meta-analysis of antidepressants in bipolar depression reported a pooled effect no different from placebo (relative risk [RR] of response 1·17, 95% CI 0·82-1·57) with statistically significant heterogeneity. 35 Meta-analyses in patients with bipolar disorder have grouped antidepressant drugs together as one class, despite the observed statistically significant heterogeneity and the evidence in patients with unipolar disorder that antidepressant agents vary to a clinically significant degree in both efficacy and tolerability.…”

Section: Treatment Of Bipolar Depressionmentioning

confidence: 99%

The Treatment of Bipolar Disorder

Möller¹,

Nasrallah²

2017

Oxford Medicine Online

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We review recent developments in the acute and long-term treatment of bipolar disorder and identify promising future routes to therapeutic innovation. Overall, advances in drug treatment remain quite modest. Antipsychotic drugs are effective in the acute treatment of mania; their efficacy in the treatment of depression is variable with the clearest evidence for quetiapine. Despite their widespread use, considerable uncertainty and controversy remains about the use of antidepressant drugs in the management of depressive episodes. Lithium has the strongest evidence for long-term relapse prevention; the evidence for anticonvulsants such as divalproex and lamotrigine is less robust and there is much uncertainty about the longer term benefits of antipsychotics. Substantial progress has been made in the development and assessment of adjunctive psychosocial interventions. Long-term maintenance and possibly acute stabilisation of depression can be enhanced by the combination of psychosocial treatments with drugs. The development of future treatments should consider both the neurobiological and psychosocial mechanisms underlying the disorder. We should continue to repurpose treatments and to recognise the role of serendipity. We should also investigate optimum combinations of pharmacological and psychotherapeutic treatments at different stages of the illness. Clarification of the mechanisms by which different treatments affect sleep and circadian rhythms and their relation with daily mood fluctuations is likely to help with the treatment selection for individual patients. To be economically viable, existing psychotherapy protocols need to be made briefer and more efficient for improved scalability and sustainability in widespread implementation.

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A Double-Blind, Placebo-Controlled Study of Quetiapine and Paroxetine as Monotherapy in Adults With Bipolar Depression (EMBOLDEN II)

Abstract: clinicaltrials.gov Identifier: NCT00119652.

Cited by 273 publications

References 47 publications

Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder

Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder

How can we classify “mood stabilizers” with different properties?

The Treatment of Bipolar Disorder

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A Double-Blind, Placebo-Controlled Study of Quetiapine and Paroxetine as Monotherapy in Adults With Bipolar Depression (EMBOLDEN II)

Abstract: clinicaltrials.gov Identifier: NCT00119652.

Cited by 273 publications

References 47 publications

Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder

Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder

How can we classify &ldquo;mood stabilizers&rdquo; with different properties?

The Treatment of Bipolar Disorder

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Product

Resources

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How can we classify “mood stabilizers” with different properties?